us consumer business slump $1bn in consumer revenues …

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No. 48 • 23 December 2019

WELLNESS

US DoJ Has ‘Key Focus’ On Supplement Industry, Adds 6 Attorneys To Sector, p. 14

BEAUTY

CIR Expert Panel Finds MCI/MI Preservative Combo Safe With Caveats, p. 9

HEALTH

Reckitt Targets UK’s Painful ‘Tweens’ With Double-Strength Nurofen, p. 5

Sanofi Sees OTC Switches Adding $1bn In Consumer Revenues By 2026EILEEN FRANCIS [email protected]

Sanofi has expectations for its stand-alone consumer health care busi-ness to launch OTC switches of erec-

tile dysfunction treatment Cialis and flu remedy Tamiflu by 2026 and add around $1bn to the French pharma’s top line, says CEO Paul Hudson.

During the firm’s investor day on 10 December in Cambridge, MA, Hudson noted a more nimble structure for the consumer business, unshackled from the Sanofi’s Rx division, will expedite developing switch applications for Cia-lis (tadalafil) and Tamiflu (oseltamivir). He said both should be approved for OTC sales and launched between 2023 and 2026. (Also see “Sanofi Forms Stand-alone Consumer Healthcare Unit: Prelude To Spin-Off?” - HBW Insight, 10 Dec, 2019.)

“There is a three-year burn of increasing the revenue because of the rules of the game,” Hudson said, referring to market exclusivity allowed for some OTC switches in the US. “We have an expectation that we could take our consumer health growth rate to 8%, 9%, 10% at that point. We don’t know yet, but it would take a lot of prepa-ration and that’s why we separated it.”

Expanding on reasons for the change, Hudson said the consumer business has slowed behind market growth “because it’s carrying Sanofi infrastructure on top of it. And it’s not agile enough, frankly, to move at the speed” of the rest of the market.

“Whilst in Rx, we can take a little bit more reflection and higher standards on some facets. You really can’t do that on consumer and we were rolling some of

the burden on the consumer business,” he said. Hudson noted Sanofi’s consumer business currently is growing at around 3% to 4% across its top 35 countries, excluding the impact of recent regula-tory investigations and recalls of its OTC Zantac heartburn drug due to regulators’ concerns about a nitrosamine impurity in all ranitidine drugs. (Also see “Zantac Re-call And EU Regulatory Issues Hurt Sanofi In Q3” - HBW Insight, 1 Nov, 2019.)

Before disclosing its plan to investors, Sanofi announced soon after Hudson took the helm in September that it was consid-ering spinning off or moving its consumer health business to a standalone division – alongside the pharmaceutical giant’s three core global business units specialty care, vaccines and general medicines.

US CONSUMER BUSINESS SLUMPHudson said the switch launches could have a “transformational effect” on Sano-fi’s US consumer business. The division’s third-quarter revenues declined 4.4% to $275m on the impact of FDA’s investiga-tion into ranitidine contamination.

“We’ve had some setbacks with the Zantac recall in the US, which will leech in a little bit to the first half of next year,” he said.

Hudson also said separating the unit with dedicated support functions and its own information technology infrastruc-ture, research and development and man-ufacturing will support developing digital health care products.

Days before its conference, Sanofi announced it is partnering with Ber-lin digital therapeutics developer Cara Care to deliver an innovative app-cen-tered treatment for irritable bowel syn-drome. The firms say they will launch in January 2020 an “innovative and holistic treatment approach” for IBS

CONTINUED ON PAGE 4

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Zero Gravity’s OTC Device Anti-Aging Claims Could Get FDA, FTC Scrutinyhttps://bit.ly/38VirPd

OMM Imports didn’t respond to National Advertising Division requests for evidence supporting claims its Perfectio devices could produce anti-aging effects similar to cosmetic procedures. The OTC devices, which work through red and infrared light-emitting diodes, are priced between $1,499-$7,999.

With Added Indication, Amarin Says Vascepa No ‘Fish Oil’ Like Omega-3shttps://bit.ly/2Q7pg7M

In Amarin’s “education process” about indication as an add-on to statin therapy to help cut CV risk in high-risk patients, it “will also be emphasizing how Vascepa is different from” Rx drugs fenofibrate and niacin “and omega-3 mixtures,” says CEO John Thero.

Stephen Hahn Takes US FDA Helm Under Cloud Of Doubt About Vaping Stancehttps://bit.ly/38U1kxe

HELP Committee ranking member Patty Murray said because of Hahn’s evasive responses to questions about curbing youth e-cigarette use during committee meeeting, she would oppose his confirmation. She also said she was not convinced Hahn would uphold FDA standards.

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GNC hires Josh Burris as chief US officer; Clasado BioSciences adds Bellchambers as commercial director; and Barentz plans expansion with Cinven investment.

exclusive online content

COVER / Sanofi Sees OTC Switches Adding $1bn In Consumer Revenues By 2026

Health 4 Vemedia Acquires GSK Brands In Italy, Strikes Deal For

GI Product In Spain

5 Reckitt Targets UK’s Painful ‘Tweens’ With Double-Strength Nurofen

6 Belgium Outlaws OTC Cough And Cold Combination Drugs

6 France Moving Paracetamol and NSAIDs Behind Pharmacy Counter From January

7 New Zealand Reverse-Switches Codeine Judging Risks Outweigh Benefits

8 Australia Looking Into In-Vitro Self-Test Deregulation

Beauty 9 CIR Expert Panel Finds MCI/MI

Preservative Combo Safe With Caveats

11 CIR Tackles Growing Natural Workload Against Backdrop Of Widely Held Safety Assumptions

12 Ulta: ‘Natural Look’ Trend Slowing Makeup Sales, But Offers Room To Innovate

13 Fragrance Creators Association Launches Online ‘Conservatory’ To Bolster Consumer Confidence

Wellness 14 US DoJ Has ‘Key Focus’ On Supplement Industry,

Adds 6 Attorneys To Sector

16 ‘Supplement’ On CBD Product Label A Bullseye For US Litigants, Says Attorney

18 Can Synthetic CBD Overcome Cannabis Stigma And Break EU Novel Foods Deadlock?

18 ‘No B.S.’ In RxBar Package-Front Claims, Advertising Self-Regulation Forum Finds

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HEALTH (OTC DRUGS)

patients in Germany that combines Sanofi’s Buscomint peppermint oil herbal drug with Cara Care’s food and symptom diary digital app to help con-sumers better recognize triggers for the condition.

Hudson also said Sanofi is benefiting from management changes he’s made in his 100 days with the firm (see sidebar ar-ticle). “We have a really formidable team that we’ve recruited, both from the [con-sumer packaged goods] and the con-sumer health care space. And so we’re getting lined up ready for making these switches successful.”

HURDLES FOR SWITCHES ACKNOWLEDGEDWhile noting switching Cialis and Thera-flu is a priority for the consumer business, Hudson also made clear he understands that US switches have slowed because remaining conditions, including ED, not already allowed for OTC indications are asymptomatic and cannot be self-diag-nosed as simply as a headache, upset stomach or heartburn.

“It’s very difficult to get Rx switches to OTC. And there’s only maybe five or six left in the next decade. We have two of them,” Hudson said. Eli Lilly & Co. li-censed exclusive rights to Sanofi to ap-ply for Cialis OTC approval and market the product in the US, Europe, Canada and Australia in 2014.

(Also see “Cialis Or Viagra Switch? Sanofi Survey, Pfizer Help Wanted Ad Could Be Signs” - HBW Insight, 18 Nov, 2016.) In July, Sanofi announced it was licensing OTC Tamiflu from Roche to attempt its first US flu treatment switch. (Also see “Sanofi Li-censes OTC Tamiflu From Roche To Attempt First US Flu Treatment Switch” - HBW In-sight, 23 Jul, 2019.)

Switch consultant Susan Lavine Cole-man says switches of both Tamiflu and Cialis present hurdles but should be pos-sible with the right supportive data.

“The hurdle for ED drugs will be in their self-selection and actual use trials demonstrating that consumers under-stand the label – including de-selection

criteria – and will adhere to it. Without a learned intermediary, it’s all on the con-sumer and that is a big challenge,” said Coleman, president of NCI Consulting Inc., in an email.

In an interview, consultant Edwin Hem-wall said a digital, extra-label component used with an ED drug available nonpre-scription could be effective and reliable in helping advise patients decide whether they should use the product. He is not concerned whether consumers would understand use of the products, but he questions the demand for an OTC ED drug in the US.

“I don’t know if the market opportu-nity for these drugs is as great as it once was, because men are able to get these products from legitimate e-medicine sites, with little or no meaningful physi-cal contact with a physician,” said Hem-wall, a former OTC switch executive in pharma firms.

Coleman added that access to the products online “through alternate and sometimes dubious channels won’t lessen FDA’s concern about what will happen in the retail channel.”

Hemwall expects an OTC Tamiflu would be the later of the two switches, given Sanofi’s recent licensing announcement. “The switches I’ve been involved in over the years, if they weren’t in a new catego-ry, they took a long time.”

Published online 12 December 2019

Vemedia Acquires GSK Brands In Italy, Strikes Deal For GI Product In SpainTOM GALLEN [email protected]

Vemedia – the Dutch subsidiary of Alpha HealthGroup – has inked a deal with GlaxoSmithKline Consumer Healthcare to acquire two OTC brands marketed in Italy in the pain

relief and wound care categories. Separately, the company has snapped up the Zeninas digestive health brand in Spain.

Alpha HealthGroup said the deal with GSK would expand its portfolio in Italy with two reputable brands: the Cibalgina ibupro-fen-based analgesic range and the Bialcol antiseptic product for cleaning wounds.

Securing the acquisition was in line with its strategy to become a leader in the European self-care market with a portfolio of “high profile brands in all major categories,” said Alpha HealthGroup,

CONTINUED FROM PAGE 1

Sanofi CEO Paul Hudson: “We have an expectation that we could take our consumer health growth rate to 8%, 9%, 10%” with OTC switches of Cialis and Tamiflu.



HEALTH (OTC DRUGS)

which is also the parent company of France’s Laboratoire Cooper and Switzer-land’s Laboratoires Diepharmex.

“These two iconic brands enjoy a solid brand equity and awareness amongst con-sumers,” insisted Alpha HealthGroup’s CEO Francis Doblin. “Through this acquisition, Vemedia strengthens its position on the Italian consumer health market, a key mar-ket for our group where Vemedia is mak-ing a remarkable performance this year.”

While GSK did not comment on the deal, it has made portfolio rationalization a priority as it looks to generate the funds needed to integrate Pfizer’s Consumer Healthcare business.

Speaking in October, GSK CFO Iain Mackay said that the firm was “moving forward with other divestments which will continue through next year.” (Also see “GSK Plans Further Divestments As Pfizer Brands Drive Up Q3 Sales” - HBW Insight, 31 Oct, 2019.)

STRIKES DEAL IN SPAINIn addition to the agreement with GSK, Vemedia has also struck a deal with Spain’s Puerto Galiano to acquire the Zeninas con-stipation treatment, which is marketed in Spain as a “100% natural product” based on Aloe vera and Rhamnus purshiana.

Alpha HealthGroup said it planned to develop the Zeninas product line and strengthen its position in the digestive segment in Spain.

“The brand was launched in 1958 and has a strong brand equity amongst con-sumers,” noted Rubén Lupiáñez, CEO of Vemedia Spain & Portugal. “We want to perpetuate this history and build on these foundations to expand the category offer-ing in the coming years.”

Alpha HealthGroup expanded its port-folio significantly earlier this year with the acquisition of Laboratoires Diepharmex.

“Diepharmex completes the group’s offer in the category of hygiene and ear care,” noted the firm at the time. “Diephar-mex will provide the group with extensive experience in launching mass media ad-vertising campaigns and an ability to de-velop a brand in an international setting.” (Also see “Cooper-Vemedia Strengthens In Europe With Diepharmex Acquisition “ - HBW Insight, 14 Jun, 2019.)


Reckitt Targets UK’s Painful ‘Tweens’ With Double-Strength Nurofen DAVID RIDLEY [email protected]

British “tweenagers” aged 7 to 12 years old are the focus of Reckitt Benckiser’s two new Nurofen for

Children line extensions in the UK. Available in strawberry and orange fla-

vors, RB said its new Nurofen for Children Double Strength (200mg/5ml liquid ibu-profen) analgesic was designed to help parents find a suitable pain relief option to manage their children’s “growing pains.”

Finding a suitable product was a “priority for parents,” according to a recent OnePoll survey conducted by the firm, with over half (51%) reporting that “they want to feel assured their child has the correct dose of pain relief to last throughout the day.”

However, finding the right product was no easy task, RB found: “When it comes to managing their children’s physical pains, finding the a suitable pain relief option can be a real challenge for parents, with nearly a quarter (24%) saying their chil-dren find syrups too childish, while 40% of parents say their children struggle to swallow pain relief tablets.”

More than a third of parents (35%) said they had “resorted to disguising their child’s pain medicine to get them to take it,” the firm continued, for example “hiding it in peanut butter (53%) or dissolving it in orange juice (67%).”

“These survey findings are important to highlight the challenging times this age group and their parents can go through as their children transition to adulthood,” commented RB’s senior brand manager for Nurofen in the UK, Marcella Christophersen.

“It’s clear that finding a suitable product for pain relief is a priority for parents, so they can feel assured their child has the correct dose of medicine to last through-out the day,” she continued. “Yet they can often struggle with formulations available for this ‘in-between age group’.”

ADOLESCENTS ALSO FEEL PAIN Finding that adolescents (12-15 years) also experienced certain types of every-day pains – including headache (66%), body pains (53%), braces pains (22%), post-sport aches (39%), and period pains (39%) – RB has also launched a product aimed at this older age group.

“For nearly one in five (18%), experienc-ing pain was cited as a worry,” RB reported. “This, combined with the fact that more than a third (36%) are away from their par-ents more than they have ever been before, means that special consideration may need to be placed on their pain relief options.”

Specifically designed for children from 12 years suffering from headaches and migraines relief, the firm said its new Nurofen Meltlets Orodispersible Tablets’ “convenient on-the-go format” meant that they could be taken without water “as soon as pain strikes.”


RB’s Nurofen For Children Double Strength

An RB survey showed

more than a third of

parents (35%) “resorted

to disguising their child’s

pain medicine to get them

to take it,” for example

“hiding it in peanut butter

(53%) or dissolving it in

orange juice (67%).”




HEALTH (OTC DRUGS)

Belgium Outlaws OTC Cough And Cold Combination DrugsTOM GALLEN [email protected]

Fixed combination OTC drugs for treating coughs and the common cold will no longer be available in Belgium from 1 January 2020.

National drug regulator AFMPS said it was pre-paring to pull all such products from shelves as not one marketing authorization holder had demonstrated their fixed combination prep-aration complied with European Medicines Agency guidelines.

A number of firms had applied for a new marketing authorization for their product af-ter reformulating it with a single active ingre-dient, the agency said.

As a result of the law change, many popular OTC fixed combinations will be withdrawn from the market including dextromethorphan and guaifenesin; codeine and guaifenesin; and noscapine and guaifenesin.

The full list of products which must be removed from pharmacy shelves by the end of the year is:● Acatar 15mg/5ml;50mg/5ml syrup (dextromethorphan hydro-

bromide/guaifenesin) from Laboratories SMB● Broncho-Pectoralis Pholcodine 15mg/300 mg syrup (pholco-

dine/guaiacolsulfonate) from Medgenix Benelux● Inalpin 9.48mg/15ml; 94.8mg/15ml syrup (codeine phosphate

hemihydrate/guaifenesin) from Laboratoria Qualiphar● Longbalsem 10mg/15ml; 100mg/15ml syrup (ethylmorphine

hydrochloride/guaifenesin) from Pharinex

● Noscaflex Expectorans syrup (noscapine hydrochloride/guai-fenesin) from Pharinex

● Pholco-Mereprine syrup (doxylamine succinate/pholco-dine/sodium benzoate/guaiacolsulfonate) from Veme-

dia. (Granted extension until May 2020).● Toplexil syrup (guaifenesin/paracetamol/oxome-

mazine/sodium benzoate) by MelisanaThe motivation for AFMPS’ move dates

back to 2012 when the EMA’s Committee for Medicinal Products for Human Use reviewed the benefit-risk balance of drugs used to

treat coughs and colds in children, including cough suppressants, expectorants and topical

nasal decongestants. Following the CHMP’s review, AFMPS asked MAHs of

all combination drugs for coughs and colds to either submit a new dossier reformulating products with a single active ingredi-ent, or demonstrate compliance with EMA’s Guideline on Clinical Development of Fixed Combination Medicinal Products (2009).

The guideline states that fixed combination products can only be considered acceptable if the proposed combination is based on valid therapeutic principles. “For any individual fixed combination it is necessary to assess the potential advantag-es in the clinical situation against possible disadvantages, in order to determine whether the product meets the require-ments of the standards and protocols with respect to efficacy and safety,” it states. Published online 16 December 2019

France Moving Paracetamol and NSAIDs Behind Pharmacy Counter From JanuaryTOM GALLEN [email protected]

Paracetamol, ibuprofen and acetylsal-icylic acid will from 15 January 2020 only be available to French consum-

ers after consultation with a pharmacist. The rationale for the move, accord-

ing to France’s drug regulator ANSM, is to promote the proper use of OTCs by strengthening the pharmacist’s advisory role. The decision will affect numerous OTC brands, notably Sanofi’s Doliprane and Bayer’s Aspirin.

Following a consultation period, ANSM said it was amending the public health code to remove the three drugs – sold alone or in combination with other active ingredients – from the country’s ‘free ac-

cess’ scheme, which allows consumers to self-select certain non-prescription prod-ucts in pharmacy. (Also see “France Wants To Move Paracetamol, Ibuprofen And As-pirin Behind The Counter” - HBW Insight, 4 Oct, 2019.)

Selling paracetamol (acetaminophen) and the two non-steroidal anti-inflam-matory drugs (NSAIDs) as free access drugs was encouraging consumers to self-treat ailments without awareness of essential information for safe and effec-tive use, ANSM claimed.

Specifically for the two NSAIDs, the agency said the drugs had numerous contraindications and precautions for

Introducing a mandatory pharmacist consultation for sales of paracetamol and NSAIDs would verify

treatment was ap propriate and reduce risk, says ANSM,

which is also looking to move alpha-amylase sore

throat treatments behind the pharmacy counter due to fears of severe allergic reactions.




HEALTH (OTC DRUGS)

use, which needed to be observed to be used safely. ANSM highlighted the risk of serious renal or infectious complications related to ibuprofen use in particular. (Also see “France Warns Of Serious Complications Related To OTC Ibuprofen Use” - HBW Insight, 25 Apr, 2019.)

Regarding paracetamol, the regulator noted that an overdose could lead to serious liver damage requiring a liver transplant or even result in death. The agency this year introduced prominent liver damage warnings to packs of both OTC and prescription paracetamol medicines to help mitigate this risk. (Also see “France Orders On-Pack Warnings For Paracetamol Over Liver Damage Fears” - HBW Insight, 10 Jul, 2019.)

Introducing a mandatory pharmacist consultation for the sale of paracetamol and NSAIDs would verify the treatment was ap-propriate for the individual and reduce risk, ANSM argued.

Moving the drugs behind the counter would not hinder pa-tients’ access to these treatments when they were justified, ANSM said, adding that the decision was a “proportionate” response to the risks and did not impose constraints “exceeding those made

strictly necessary by the requirements of the protection of pub-lic health.” France’s OTC industry appealed to ANSM not to go ahead with the move and suggested alternative measures which could be used to ensure patient safety. These included logging all paracetamol and NSAID purchases in a patient’s medical records and launching a public information campaign.

However, ANSM rejected these options, judging them to be nei-ther suitable nor sufficient to mitigate against the perceived risks to patients.

ANSM is also looking to move sore throat treatments contain-ing alpha-amylase behind the pharmacy counter over fears the products could trigger severe allergic reactions.

Sanofi’s Maxilase Maux de gorge Alpha-Amylase, along with Alfa-amylase Biogaran conseil and Alfa-amylase Top Pharm are the products affected by the decision. (Also see “Sore Throat Drugs Heading Behind The Counter In France Over Safety Fears” - HBW In-sight, 2 Dec, 2019.)


New Zealand Reverse-Switches Codeine Judging Risks Outweigh BenefitsTOM GALLEN [email protected]

New Zealand is set to reverse-switch from OTC to prescrip-tion status all medicines containing codeine over patient safety concerns.

Following three years of deliberation and consultation, drug regulator Medsafe’s Medicines Classification Committee (MCC) has recommended that all medicines containing codeine sold in New Zealand should be classified as prescription medicines, ending their pharmacy-only or pharmacist-only availability. This move will harmonize the classification with Australia, which re-verse-switched codeine in 2018.

A time frame for implementing the decision has not yet been finalized, with Medsafe promising to set this out in consultation with all stakeholders.

Reverse-switching codeine was justified, the MCC judged, by patient safety concerns, in particular the risk of exceeding the

maximum dosage of paracetamol and ibuprofen in codeine com-bination products, as well as the abuse of the opioid drug in New Zealand and globally.

Noting that patients using codeine were often seeking addition-al pain relief to that provided by less potent OTC drugs, the MCC argued that there was a real risk of overdosing on the other ingre-dients in codeine combination products – such as paracetamol or ibuprofen – which could lead to damage to the liver or kidneys.

Furthermore, the efficacy of these combination products con-taining a low dose of codeine was poor, the regulator argued, so as OTC drugs were not satisfying an unmet need for pain relief.

Adding to the safety concerns, ultra-rapid metabolisers were at increased risk of morphine toxicity with codeine use, the MCC noted, given that codeine was a pro-drug for morphine.

PROTESTS FALL ON DEAF EARSIn confirming the reverse switch, Medsafe rejected the protesta-tions of local OTC industry association NZSMI which argued that adverse events related to codeine were low in comparison to the volume of sales, and warned that the reclassification would lead to increased costs to government through prescription subsidy, as well as additional pressure on general practitioners.

To allay Medsafe’s concerns, NZSMI proposed that all codeine containing products could be restricted for sale by pharmacists only, with the additional safety measure of recording all purchases in a real-time monitoring system. However, the regulator said this was not a practical solution as national coverage of electronic monitoring systems was incomplete and insufficient to be con-sidered adequate for continuing non-prescription codeine sales.




HEALTH (OTC DRUGS)

Medsafe initially announced plans to reverse switch all co-deine combination medicines to prescription-only status by the end of January 2020, but at the time stopped short of reverse-switching products containing codeine as the only ac-tive ingredient.

The MCC recommended that medicines containing codeine as the only active ingredient should be reclassified to restricted medicine; for oral use in adults and children over 12 years of age in medicines containing not more than 15 mg per solid dosage unit with a maximum daily dose not exceeding 90 mg of codeine for use as an analgesic and when sold in a pack of not more than three days’ supply.

However, before implementing this decision the Ministry of Health’s delegate requested further information from Medsafe. After a longer period of reflection and consultation, the MCC ul-

timately determined that giving codeine restricted status did not go far enough. New data which came to light during this period from Australia also appears to have influenced the Committee’s decision. Earlier this year, the Australian Medical Association re-ported that the reverse-switch of codeine in Australia had been “vindicated” by a 50% drop in the drug’s supply. (Also see “Austra-lia’s Codeine Reverse-Switch “Vindicated” By 50% Drop In Supply” - HBW Insight, 15 May, 2019.)

Medsafe is the latest national drug regulator to reverse-switch codeine over safety fears, with authorities across Europe either en-acting or weighing similar moves. (Also see “OTCs Under Threat In Europe: Calls To Reverse-Switch Codeine And Others In Poland And Ireland” - HBW Insight, 19 Mar, 2019.)


Australia Looking Into In-Vitro Self-Test DeregulationDAVID RIDLEY [email protected]

Access to direct-to-consumer (DTC) self-tests for a variety of serious diseases and conditions could be widened in Aus-tralia, according to a recent consultation by the country’s

Therapeutic Goods Administration. Part of its “deregulation agenda,” the Australian government

is revisiting the “Excluded Purposes Specification” (EPS) – due to “sunset” on 1 October 2020 – which specifies self-testing in-vitro medical devices (IVDs) that are currently excluded from supply to consumers.

“Technological developments in recent years have made IVDs for self-testing less expensive and more readily available,” TGA notes. “There is also a growing desire by consumers to have more say in their healthcare decisions.”

As with many other countries, Australia does not prohibit the DTC supply of self-tests to monitor health-related factors such as cholesterol or glucose levels, to provide personalised dietary rec-ommendations and weight management solutions or to test for pregnancy.

However, it does prohibit the following:● Tests for the presence of, or exposure to, pathogenic organisms

or transmissible agents (other than HIV), including agents that cause notifiable infectious diseases;

● Genetic tests to determine the presence of, or susceptibility to, diseases in humans;

● Tests to diagnose, aid in diagnosis or indicate the presence of a serious disease or condition, such as cancer or myocardial infarction;

● Tests for the presence of markers that are precursors to a seri-ous disease or condition, such as Pap smear tests (marker for cervical cancer) or prostate specific antigen tests (marker for prostate cancer).The problem, according to TGA, is that “some consumers are

making use of an exemption in [Australia’s medical devices regu-lations] that allows them to order self-tests over the internet and import them into Australia for personal use, circumventing the Excluded Purposes Specification.”

To address the concern that consumers were using self-tests whose “safety and performance … has not been assessed by the TGA” – and also following the successful exemption of HIV self-tests in 2014 – the agency’s consultation asks whether any or all of the above categories should also be exempted from the EPS, outlining in the process the pros and cons of such a move in each case.

GOING VIRAL With regards self-tests for “notable” infectious diseases other than HIV, such as influenza and hepatitis C, making such devices avail-able DTC would “allow for early screening and intervention if re-quired” and would also in some cases make testing accessible to consumers who “would not otherwise be tested,” TGA explained, for example individuals “who are not comfortable accessing cur-rent health services” or “people in remote communities.”

Viral infections such as influenza placed an “overwhelming de-mand” on Australia’s healthcare services, particularly Emergency Departments (EDs) and general practitioners (GPs), TGA pointed out, especially during “seasonal peaks.”

By allowing consumers with flu-like symptoms to be tested at home before deciding whether to seek medical treatment, TGA ar-



HEALTH (OTC DRUGS)

gued that making flu tests available DTC would reduce the demand on these already overstretched services. “Earlier use of rapid screen-ing for influenza could also reduce the severity of the disease by allowing for earlier treatment with antiviral drugs,” TGA added.

Furthermore, self-testing for sexually transmitted and other infec-tious diseases (e.g. human papilloma virus, syphilis and chlamydia) would encourage earlier medical intervention and treatment when required, TGA continued. “The availability of self-tests for viruses such as hepatitis C may help increase testing rates and improve outcomes particularly in hard-to-reach populations,” the agency insisted.

However, a major concern relating to self-tests for these infec-tious diseases – a concern also raised in relation to HIV self-tests – was the accuracy of tests and risk of false negative or false positive results, TGA explained.

“Consumers with a false negative result may incorrectly assume they do not have a particular infection while a false positive result may cause undue distress to an individual,” TGA warned.

If flu or STI self-tests were to be made available DTC in Australia, the agency said that these concerns “would need to addressed” and as is the case with self-testing IVDs for HIV, “risk mitigations would need to be put in place to ensure that the benefits from use of the devices outweigh the risks.”

These mitigations could include ensuring, TGA suggested:● that sample collection and test procedures are straightforward

and easy to perform;● the test kit or device is robust and stable under a range of envi-

ronmental conditions;● that the sensitivity and specificity of the test is suitable to mini-

mize the risk of false negative and false positive results;● the interpretation of test results is clear and unambiguous and

appropriate advice is available about follow up actions required and support services.

GENE OUT OF THE BOTTLE DTC genetic tests were particularly problematic from the point of view of online sales, TGA said, as such tests were “currently outside the reach of Australia’s legislation” and had in many cases “limited clinical evidence to support their use.”

Exact numbers of such self-tests supplied via the internet could not be determined, TGA acknowledged, but the agency said that

consumers were increasingly turning to them to “predict suscep-tibility to common multi-factorial conditions, such as diabetes, obesity and heart disease” or to “determine carrier status for preg-nancy planning or for pre-natal testing.”

As with self-tests for infectious diseases like HIV, hep C and the flu, the main challenge for DTC genetic tests was interpreting the results, TGA warned.

“While genetic testing can be a very powerful tool in diag-nosing or predicting the risk of some serious diseases or condi-tions, the interpretation of many of those risk factors can be quite challenging and may have implications for family mem-bers,” TGA noted.

“A lay person may be unnecessarily alarmed by results if the risks are misinterpreted or are not adequately explained in the re-port they receive,” it added.

However, DTC genetic tests had the potential to significantly “em-power” consumers to “take greater responsibility for their health, and adopt health promoting behaviors, particularly if a higher risk of developing a particular disease is identified,” TGA insisted.

Making supply of these tests “conditional on the provision of appropriate consumer information and referrals to health profes-sional services” was one way that the risk-benefit balance could be restored, TGA suggested.

DTC genetic tests that were “not supported by appropriate clini-cal evidence and analytical performance data” could also be pro-hibited from supply by TGA, the agency added.

“The risks associated with DTC genetic tests can be minimized if the tests are regulated and evaluated by the TGA to ensure that any risks are appropriately mitigated,” the agency commented. “If DTC genetic tests that meet acceptable quality and performance standards could be supplied as self-testing IVDs in Australia they would offer consumers an alternative to overseas services of un-known quality and performance.”

TGA also asked whether self-tests for other serious diseases or conditions such as diabetes, cancer or myocardial infarction should be made available DTC, pointing out that these tests in-volved similar risks and benefits to the other tests considered in the consultation, which closed on 6 December.


� B E A U T Y �

CIR Expert Panel Finds MCI/MI Preservative Combo Safe With CaveatsRYAN NELSON [email protected]

T he Cosmetic Ingredient Review’s Expert Panel determined the preservative mixture of methylchloroisothiazolinone and methylisothiazolinone (MCI/MI) safe for use at its 9-10

December meeting in Washington, albeit with stipulations con-cerning sensitization potential.

The MCI/MI combo (in a roughly 3:1 ratio) can be used safely in rinse-off and leave-on cosmetics at maximum concentrations of 15 parts per million and 7.5 ppm, respectively, when formulated

to be non-sensitizing, according to the final panel decision sum-marized in CIR’s post-meeting announcement.

The Expert Panel’s MCI/MI assessment should shore up industry confidence in the preservative system’s use in the states.

NGOs, on the other hand, are likely to be critical of the review’s outcome.

The CIR panel’s newly finalized report essentially reaffirms its safety finding for MCI/MI back in 1992. Since then, concerns




BEAUTY (COSMETICS)

have risen sharply about the preservative ingredients’ escalating use in cosmetics and widespread reports of increased allergenic-ity, which prompted the American Contact Dermatitis Society to name MI the 2013 Contact Allergen of the Year.

In 2014, the European Commission banned the MCI/MI mixture’s use in leave-on cosmetics. (Also see “Europe Bans Preservative Mixture MCI/MI In Leave-On Cosmetics” - HBW In-sight, 26 Sep, 2014.)

CIR’s experts are well aware of the global regulatory picture and available sensitization data, as compiled by CIR staff from pub-lished literature and stakeholder submissions. They also examined an updated quantitative risk assessment for skin sensitization pro-vided by industry.

Regarding the QRA, its results signaled to the panel “that some leave-on products comprising MCI/MI at the recommend-ed maximum safe concentration of 7.5 ppm may yet increase

CIR Expert Panel Assessments: December 2019

INGREDIENT/GROUP FUNCTION (NON-INCLUSIVE)INDUSTRY USES

(ESTIMATES BASED ON 2019 FDA/VCRP DATA)

REPORT STATUS DECISION

Alkyl Amide MIPA (14 ingredients)

Surfactant-foam booster, viscosity-increasing agent

>800 FinalSafe with qualifications (a)

Capryloyl Salicylic Acid Skin conditioning 104 Insufficient (b) N/A

Mannitol, Sorbitol, & Xylitol (3 ingredients)

Humectant, skin conditioning >2,800 Final Safe

MCI/MI (1 ingredient mixture) Preservative N/A FinalSafe with qualifications (c)

Honey (7 ingredients)

Skin conditioning, flavoring, abrasive, binder, depilating, exfoliant, hair conditioning, nail conditioning

>1,300 Tentative Safe

Palm (açaí and juçara) (8 ingredients)

Skin conditioning >430 Tentative Split conclusion (d)

Pomegranate (18 ingredients) Skin conditioning >480 Tentative Split conclusion (e)

Soy (28 ingredients) Antioxidant, skin protectant, skin conditioning, hair conditioning

>450 Tentative Split conclusion (f )

Vanilla (9 ingredients)Skin conditioning, abrasive, antioxidant

>370 Tentative Split conclusion (g)

Amino Acid Diacetates (2 ingredients)

Chelating agent 796Insufficient Data Announcement (h)

N/A

Cocos Nucifera (Coconut)-De-rived Ingredients (9 ingredients)

Skin conditioning, humectant, abrasive, hair conditioning

>500Insufficient Data Announcement (h)

N/A

Glycerin Ethoxylates (8 ingredients)

Skin conditioning, viscosity-decreasing agent

>460Insufficient Data Announcement (h)

N/A

Polysilicone-11 Film former 420Insufficient Data Announcement (h)

N/A

Caprylhydroxamic Acid Chelating agent 227 Tabled (i) N/A

(a) When formulated to be non-irritating;

(b) Data needed on impurities and phototoxicity;

(c) Safe at concentrations of 15 ppm in rinse-off products, or 7.5 ppm in leave-on products, when formulated to be non-sensitizing;

(d) Seven palm ingredients are safe for use in current practices of use and concentration. However, available data are insufficient for Euterpe Olera-cea Palm Heart Extract, which lacks composition data and, based on that information, potentially dermal irritation and sensitization data;

(e) Eight pomegranate ingredients are safe as currently used, but 10 require additional data on method of manufacture (especially with regard to solvent used for the extracts), composition and impurities data, systemic toxicity data, and dermal irritation and sensitization data;

(f ) Four soy ingredients, none reported to be used at present, require data on composition, impurities, method of manufacture, 28-day dermal toxic-ity and dermal sensitization/irritation;

(g) Two ingredients, Vanilla Planifolia Flower Extract and Vanilla Planifolia Leaf Cell Extract, lack data on method of manufacture and impurities, composition, concentration of use, 28-day dermal toxicity, and potentially other toxicological endpoints;

(h) See CIR’s post-meeting announcement for data specifications;

(i) The Expert Panel awaits human repeat insult patch testing (HRIPT) requested from industry, which it expects to be available for consideration at its March 2020 meeting.


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the risk of inducing dermal sensitization,” CIR notes in its meet-ing recap. The panel determined that “individuals previously sensitized to MCI/MI should avoid products that contain this ingredient mixture.”

CIR’s experts are known to include such language when evalu-ating ingredients with well-documented sensitization potential, including those derived from natural (eg, botanical) sources.

The onus falls on industry to formulate responsibly, and on consumers with allergy histories to know their enemy and check product labels accordingly.

But cosmetics-related allergy is an issue of growing interest around the world, including in the US, where legislative reform proposals in Congress – including the Cosmetic Safety Enhance-ment Act of 2019, recently introduced by Rep. Frank Pallone, D-NJ – would require companies to disclose fragrance allergens on product labels. (Also see “US House Cosmetics Hearing: Preemp-tion, FDA Ingredient Review Could Be Regulatory Reform Snags” - HBW Insight, 5 Dec, 2019.)

Meanwhile, the US Food and Drug Administration is working to get a better sense of how prevalent cosmetics allergies are in the US. (Also see “FDA Moves Forward With Planned Cosmetic Allergy Survey, Defends Practical Utility, Statistical Power “ - HBW Insight, 20 Nov, 2019.)

CIR NOT TELLING WHOLE STORY, NGO SUGGESTS Advocacy group Women’s Voices for the Earth had concerns about the MCI/MI review going into the December meeting.

“There is some very important contextual information miss-ing from the MCI/MI Safety Assessment – which is that the con-sensus of dermatological experts around the world is that there has been an epidemic of sensitizations to MI and MCI/MI caused by the significant increases in the use of these chemicals in cos-metics in recent decades,” asserts Alexandra Scranton, WVE’s director of science and research, in comments submitted to CIR in late November.

She adds, “The rate and speed at which MI and MCI/MI became known as significant skin sensitizers was unprecedented and caused alarm internationally. … This aspect is not currently mentioned in this safety assessment which appears to be a major oversight.”

Scranton further alleges that MCI and MI sensitization rates have continued to climb in the US in recent years, compared with apparent declines in foreign markets where tighter controls have been instituted.

“We now know that an epidemic of sensitization among the current generation could potentially have been avoided if the CIR had made a different decision on MCI/MI in cosmetics back in 1992. … Making the wrong decision [again] means thousands of additional Americans could be unnecessarily sensitized to iso-thiazilinones. This is a responsibility that the CIR must take very seriously,” she says.

WVE has established itself as the most active NGO participant in the CIR’s public exchanges and one of the industry-funded pro-gram’s most outspoken critics. (Also see “CIR Panel Not Changing Its Mind About Parabens Safety, Renewing NGO Accusations Of Bias “ - HBW Insight, 4 Oct, 2018.)

Use of MCI/MI has increased in the past decade at least in part due to industry’s loss of alternative preservative systems under bans and restrictions established by regulatory authorities and pressure imposed on manufacturers by activist elements.

It is not entirely clear the extent to which industry’s shrinking pre-servative palette threatens the diversity of cosmetic products avail-able to consumers or their microbiological safety, though the issue continues to be a significant concern for industry and regulatory authorities. (Also see “EC Trims Permitted Cosmetic Preservatives List, Warns About ‘Stigmatizing’ Safe Options” - HBW Insight, 24 Jul, 2017.)

The CIR Expert Panel issued four final safety assessments over-all at its December meeting, along with five tentative reports and four insufficient data announcements.


CIR Tackles Growing Natural Workload Against Backdrop Of Widely Held Safety AssumptionsRYAN NELSON [email protected]

The Cosmetic Ingredient Review Expert Panel’s 153rd meet-ing in Washington focused heavily on naturally derived ingredients, reflecting the group’s shifting priorities in line

with trending formulation practices in the personal-care industry.The overall majority of palm, pomegranate, soy and vanilla in-

gredients evaluated by the panel are safe as currently used by the cosmetics industry, according to tentative decisions rendered at the panel’s 9-10 December meeting.

Exceptions and outstanding data needs are identified in CIR’s post-meeting announcement.

Additionally, honey- and coconut-derived ingredients – seven and nine ingredients in each group, respectively – received first looks from the panel at the meeting.

CIR’s experts issued a tentative safe-as-used decision for the hon-ey ingredients, which feature in more than 1,300 known cosmetic products on the US market, according to data from the US Food and Drug Administration’s Voluntary Cosmetic Registration Program.

Per CIR’s announcement, sensitization data was lacking for six of the seven honey ingredients, but the panel was comfort-able extrapolating findings for honey extract to support the remaining substances.

The panel also noted the ingredients’ medical use in wound dressings and long use in foods, without a history of reported adverse events, as further evidence of their demonstrated safety.

“The panel suggested the inclusion of language suggesting limitations of pesticides and endotoxins, as well as avoiding the




BEAUTY (COSMETICS)

use of honey derived from toxic plant sources (e.g., oleander) when formulating with these ingredients,” CIR says.

The Expert Panel was less confident in the body of data available for coconut-derived ingredients, used in more than 500 cosmetics voluntarily registered with the FDA.

Ingredients in the group lack information on manufacturing methods, composition and impurities, dermal toxicity, genotoxic-ity, and dermal irritation and sensitization, among other potential safety endpoints, according to CIR’s meeting recap.

CIR’s focus on natural ingredients in-creased sharply in 2019.

The industry-funded organization has noted that botanical ingredients can pose unique review challenges, given that in-gredients of the same designation can have different chemical makeups and safety profiles, depending on how they are derived and manufactured. (Also see “CIR’s Ginkgo Biloba Review Illustrates Growing Botanical Challenges” - HBW In-sight, 13 Mar, 2018.)

In light of such complexities, CIR’s Expert Panel has not been reserved about requesting additional data from industry. For example, soy- and vanilla-derived ingredients were subject to in-sufficient data announcements issued by the panel in June.

A group of brown algae ingredients, 82 in total, also required additional data submissions before the panel could de-termine 68 of the ingredients safe as used, a final decision it reached in Sep-tember. (Also see “CIR Expert Panel Issues

Three Final Safety Assessments, Six Tenta-tive, At 152nd Meeting” - HBW Insight, 24 Sep, 2019.)

NATURAL NOT SYNONYMOUS WITH SAFE Overall, industry has been largely success-ful in supporting the safety of naturally derived ingredients to the CIR Expert Pan-el’s satisfaction.

However, CIR Executive Director Bart Heldreth seems intent on managing ex-pectations around the group’s burgeon-ing natural ingredient work, as well as its ongoing review of synthetics.

In his director’s report included in the post-meeting announcement, Hel-dreth points to a pair of commentaries published in scientific journals in re-cent months, each contesting widely held assumptions about natural ingre-dient safety.

One of the editorials, published in JAMA Dermatology in late September and freely available in full, offers perspective from Bruce Brod of the University of Pennsylva-nia’s Department of Dermatology.

Titled “Natural Does Not Mean Safe – The Dirt on Clean Beauty Products,” Brod’s commentary notes the ambigu-ity of terms such as “natural” and “clean,” which lack regulatory definitions if not the fascination of bloggers and celebrity influencers. He cites Goop’s Gwyneth Pal-trow in particular.

“Many of the ingredients that have been denounced by clean beauty evan-gelists seem to be selected haphazardly as companies attempt to ‘greenwash’ their

products to make them more attractive to conscientious shoppers,” he observes.

He highlights ingredients blacklisted by retailers in the name of green chem-istry, such as petrolatum, which appears on Whole Foods Market Inc.’s “unaccept-able” list for Premium Body Care.

“Dermatologists have consistently rec-ommended [petrolatum] to patients with skin barrier disruption owing to its nonal-lergenicity, superior qualities as a humec-tant, and economical cost that makes it accessible to patients of all backgrounds,” Brod points out.

The dermatologist also notes growing distaste for parabens, some of the least allergenic preservatives available, he says.

Meanwhile, many “natural” products on the market contain heavy concentrations of botanical extracts linked to high rates of irritant and allergic contact dermatitis and photosensitization, according to Brod.

“Unwarranted avoidance of low-aller-gen and safe preservatives and increased use of botanicals has been associated with a new epidemic of contact dermati-tis, which is responsible for high medical bills, time away from work and family, and a diminished quality of life,” he says.

The dermatologist goes on to contrast the safety findings, methodology and agenda of clean beauty advocate the Environmental Working Group against the work of CIR, which he character-izes as a transparent, science-based program driven by dermatological and toxicological expertise.


Ulta: ‘Natural Look’ Trend Slowing Makeup Sales, But Offers Room To InnovateLAUREN NARDELLA [email protected]

T he trend of consumers embracing the “natural look” is caus-ing a downward impact on color cosmetics sales in the US but also offers cross-category opportunities for marketers,

according to executives from retailer Ulta Beauty, Inc.During a 5 December earnings call, CEO Mary Dillon empha-

sized that while cosmetics sales are declining, consumers are still wearing and buying makeup.

“We’re seeing interest in a more natural look, which is different than bare face and actually requires multiple products to create

a neutral and glowy look,” she said. But with the “more natural look” not requiring as many products as the contouring, high-lighting and eyebrow styling trends that filled consumers’ shop-ping baskets from 2014 through 2018, current makeup sales are in a downcycle.

Dillon expressed confidence that manufacturers will “bring newness and innovation to the category,” characterizing it as a “solvable” problem but acknowledging that it will take some time to return to color cosmetic growth.



BEAUTY (COSMETICS)

“There’s always shifting preferences, the demographic trends really continue to be favorable for us, and our brand partners are very laser-focused on white space, in-novation and category-growing opportu-nities,” she added.

Analysts during the call pressed the ex-ecutive on when she sees the market turn-ing around, but Dillon held firm and didn’t give specific guidance.

However, she suggested Ulta is well-positioned to weather the headwinds impacting makeup sales with its diverse product lineup, specifically within skin care, as it has added more than 30 skin-care brands to its offerings across both mass and prestige.

Ulta hopes the offerings will be attrac-tive to Generation Z, consumers born between roughly 1996 and 2015, and en-courage them to continue as customers.

“We’re seeing that the Gen Z demo-graphic is more engaged in skincare than other cohorts who were at the same age, which bodes well for longer-term growth for the category,” Dillon said.

Additionally, they may swing back to-ward makeup as they begin to enter the workforce in the coming years, she added.

Ulta sales advanced 7.9% to $1.7bn for its fiscal 2019 third quarter end-ing 2 November while net income dropped 1% from the year-ago period to $129.7m.

Comparable sales – derived from e-commerce and sales from stores open at least 14 months – increased 3.2% on a

2.3% transaction growth and 0.9% uptick in average ticket.

While Bolingbrook, IL-based Ulta doesn’t break down sales by product cat-egory, it reported cosmetics sales com-prised 51% of total sales in the quarter, down from 53% percent.

Barclay’s analyst Adrienne Yih asked executives during the call about how the pending deal between Coty Inc. and Ky-lie Cosmetics would impact Ulta, as it has an exclusive partnership with the power-house brand.

Dave Kimbell, president and chief merchandising and marketing officer, said Ulta has a good relationship with both Kylie and Coty, “and we anticipate a lot of positive opportunities to con-tinue to grow those brands together going forward.”

Coty recently purchased 51% of Ky-lie, created by reality TV star Kylie Jen-ner, for $600m, with plans to take the brand global.


Ulta CEO Mary Dillon: “There’s always shifting preferences, the demographic trends really continue to be favorable for us.”

Fragrance Creators Association Launches Online ‘Conservatory’ To Bolster Consumer ConfidenceRYAN NELSON [email protected]

The Fragrance Creators Association is touting its new on-line Fragrance Conservatory as a first-of-its-kind resource to inform the public and bolster consumer confidence in

scented product use. “For the first time, the fragrance industry is sharing its story

to help consumers better understand the crucial role fragrance plays in our emotions, our memories, our relationships, and our everyday lives,” states FCA President and CEO Farah Ahmed in the group’s 12 December launch announcement.

The niftily designed website also provides a look at the art and science of perfumery, allows visitors to explore the history of fragrance from antiquity to modern day, highlights indus-try sustainability advances, and breaks down the regulatory landscape and voluntary safety programs governing fragrance ingredient use.

The site’s Ingredient Directory offers a deeper look, featuring 50 fragrance “stories” with detail about their olfactory profiles, origins in nature, synonyms, chemical structure and safety.

For example, the first entry, acetaldehyde, is primarily fruity, sec-ondarily appley, found in whiskey, cheese and cucumbers, and is also known as Eastman acetaldehyde and octowy aldehyde, ac-cording to FCA.

Some ingredients, such as limonene and alpha-amylcinnamal-dehyde, are identified as potential skin sensitizers, based on as-sessments conducted by European Union scientific bodies.

“This means that it has the potential to cause a temporary skin reaction (such as red, bumpy or itchy skin). These reactions can be hard to identify, and they are just as likely to be caused by natural ingredients as synthetic ingredients,” FCA says.

For every ingredient, the group provides a summary of find-ings from the Research Institute for Fragrance Materials including

At minimum, the Fragrance

Conservatory offers an enlightening ride

through a complex world that is widely

misunderstood and likely too often

taken for granted.




BEAUTY (COSMETICS)

US DoJ Has ‘Key Focus’ On Supplement Industry, Adds 6 Attorneys To SectorMALCOLM SPICER [email protected]

T he dietary supplement industry is among the Department of Justice’s five key focus areas in medical and health care products, and for good reason, say attorneys in the Con-

sumer Protection Branch.“The Department of Justice has recognized the need for greater

action against abuse in the dietary supplement space. It is just common sense that there’s going to be fraud where you have the combination of high growth, developing science, imported products or ingredients and limited oversight,” said David Morrell,

deputy assistant US attorney in the branch’s Civil Division, on 11 December at a Food and Drug Law Institute conference.

In a separate presentation on the same day at the confer-ence in Washington, Patrick Runkle, a trial attorney in the CPB, said the prevalence of the stimulant 1,3-dimethylamylamine and other non-compliant ingredients in products marketed as supplements available in the US raises questions about whether the Dietary Supplement Health and Education Act passed in 1994 gives the Food and Drug Administration ad-

discussion, when applicable, of No Expected Sensitization Induc-tion Levels, voluntary use standards established by the Interna-tional Fragrance Association, and patch test study findings.

“Over the last 50 years, the fragrance industry has remained committed to evaluating and substantiating the safety of fra-grance ingredients used in everyday consumer products. The Fragrance Conservatory advances that mission by providing ev-eryone with a go-to digital resource with credible, contextualized, and sound science-based information about the fragrance indus-try,” FCA states in its release. (Also see “Fragrance Creators Associa-tion Readies New Consumer Website To Cap ‘Year For The Public’” - HBW Insight, 8 Dec, 2019.)

Driven in large part by NGO campaigns and its fierce protection of intellectual property, the fragrance industry has come to be seen among critics as a cloistered society steeped in toxic chemi-cal secrets.

Legislative proposals are on the rise, and succeeding in Califor-nia, to “unmask” fragrance compositions. (Also see “California Fra-grance Disclosure Bill Screeches To Halt As Legislature Adjourns For Year; Now What?” - HBW Insight, 25 Sep, 2019.)

“Like a treasured family recipe, every fragrance is a unique work of art,” FCA asserts on the new site.

It continues, “As such, these ‘recipes’ are not shared publicly to ensure others cannot create counterfeit versions. Unfortunately, this practice has led people to believe the fragrance industry has something to hide. This is not true.”

The Fragrance Conservatory could go some distance in reassur-ing consumers of that. At minimum, it offers an enlightening ride through a complex world that is widely misunderstood and prob-ably too often taken for granted.


� WE L L N E S S �

Enforce By Regulation, Not Guidance Stakeholders in the supplement and other industries subject to FDA oversight could expect the branch to be more circumspect about alleged violations executive agencies bring to the DoJ division for litigation.

Morrell said CPB is adhering to an executive order President Trump made earlier in 2019 instructing federal agencies to file charges of regulatory violations based on noncompliance with actual rules and laws.

“The executive order is designed to prevent unfair surprises and to ensure that agency guidance does not become a back door means of regulation,” he said, adding that “violations of law should be based on statutes and regulations enacted in proper notice and comment.”

Morrell pointed out that the president noted when he issued the order on 9 October, “many federal agencies have issued thousands of guidance documents and instead of serving their purported and intended purpose, namely guidance, the docu-

ments often morph into requirements used to assign liability.”

He added that the executive order reinforces the approach the DoJ always has followed when litigating regulatory complaints brought by other federal agencies. “Nothing here has changed and the department may still take enforcement action consis-tent with agency policy statements including FDA’s compliance policy guidelines so long as those statements are not the sole basis for enforcement and are firmly based in statute or regula-tion,” Morrell said.

The DoJ’s emphasis on enforcing against actual regulatory noncompliance opposed to running afoul of agency guid-ance should be important to the supplement industry, which occasionally has accused the FDA of “regulation by guidance” for compliance with the new dietary ingredient notification re-quirement. The two draft guidances the agency has published on the requirement don’t align with the NDI notification lan-guage in DSHEA, some stakeholders say.



WELLNESS (DIETARY SUPPLEMENTS)

equate authority for effective oversight of the industry.

“I think it would be surprising to the senators and congresspeople who voted for DSHEA that something like DMAA could possibly be a part of what they vot-ed to allow,” Runkle said.

Morrell said CPB’s other key areas in FDA-related cases are illegal sales and imports of opioid-containing drugs; drug compounding; regulatory interference; and vaping product sales. He and Runkle both discussed the branch’s criteria for considering whether to file civil com-plaints or seek criminal charges following FDA investigations. The DoJ litigates civil complaints and prosecute criminal charg-es from FDA investigations.

“They have their own enforcement tools, but we get involved if those tools fail to bring a company back into compli-ance. We exercise our independent litiga-tion authority and judgment to seek relief,” Morrell said.

And the CPB’s Civil Division prosecutes criminal charges, too. “Don’t let the civil moniker fool you We advance our work using both civil and criminal tools, includ-ing criminal enforcement action,” he said.

CPB STAFFING INCREASINGMorrell pointed out the CPB litigates civil complaints from FDA investigations particularly when the agency provides evidence that firms aren’t compliant after multiple opportunities to correct their problems.

“We’ve also used our civil tools to en-join various supplement manufacturers and distributors who were making unap-proved drug claims about their products and failing to adhere to current good manufacturing practices, which are essen-tial to ensuring that supplements contain what is promised and are not adulterated,” he said.

“We share the FDA’s concern that the making of unapproved new drug claims risks leading patients to forego approved and safe medical treatment, which obvi-ously leads to predictable patient harm.”

Morrell also noted that CPB staffing has increased during the Trump admin-istration, from less than 40 prosecutors in 2017 to nearly 70 currently and by tri-pling its support staff of clerks, paralegals and investigators.

The increase, he said, will have a direct impact on the branch’s supplement indus-try work – an additional six attorneys join-ing CPB will focus on it. “You can expect DoJ to increase its resources devoted to investigating and litigating in this area.”

Morrell also noted that CPB staffing has increased during the Trump administra-tion, from less than 40 prosecutors in 2017 to nearly 70 currently and by tripling its support staff of clerks, paralegals and in-vestigators.

The increase, he said, will have a direct impact on the branch’s supplement indus-try work – an additional six attorneys join-ing CPB will focus on it. “You can expect DoJ to increase its resources devoted to investigating and litigating in this area.”

He noted DoJ’s work following FDA investigations that has led to criminal convictions in 2019. Five convictions an-nounced in March were from charges stemming from the FDA’s investigation of USPlabs LLC, which continued, after it and nine other sports nutrition firms were warned by the agency in 2012, to mar-ket DMAA-containing OxyElite Pro and Jack3D strength-training supplements.

USPlabs argued that DMAA is a natu-rally occurring substance found in gera-nium plants and that studies show it is a dietary ingredient and should be allowed for use in supplements, but the Dallas firm remained in FDA’s crosshairs when its Oxy-Elite Pro products, which it said had been reformulated without DMAA, were linked in 2013 to around 30 non-viral hepatitis cases in Hawaii.

Another criminal case CPB is prosecut-ing, from charges announced in March following an FDA investigation, marks its first on charges under the Designer Ana-bolic Steroid Control Act of 2014, Morrell

said. Florida firms Blackstone Labs LLC and Ventech Labs LLC and executives with both were indicted in March.

The act, strongly backed by supplement industry trade groups, closed a loophole exploited by some steroid manufacturers to market products they say are all-natural but actually contain chemically altered versions of anabolic steroids. DASCA also creates enhanced civil and criminal pen-alties for importing, manufacturing or distributing anabolic steroids under false labels. (Also see “Industry News Roundup” - Pink Sheet, 15 Dec, 2014.)

DSHEA COMPLIANCE ‘A VERY FRAUGHT FIELD’The CPB is aware of the dispute between the FDA and the industry over the agen-cy’s new dietary ingredient notification re-quirement, and Runkle said it’s a reason to consider whether DSHEA could be made better for compliant industry’s interest as well to protect consumers from noncom-pliant businesses in the space.

“You only to need to look at the NDI guidance to really see that it’s just a very fraught field,” he said.

“We have our concerns from a regulato-ry standpoint about DSHEA and whether it’s a strong enough regime to protect the public. But on the other hand … is DSHEA clear enough, does it give guidance to both the government and the industry? Everybody has concerns about that since the law was passed,” he said.

Still, disputes focused narrowly on whether an NDI notification is needed for a substance used in a supplement aren’t likely to generate DoJ litigation or prose-cution. CPB responds to evidence of firms making or marketing products labeled as supplements but spiked with drugs not-withstanding whether the FDA also con-tends that its NDI notification guidance has been violated, Runkle said.

“When you’re talking about the current state of dietary supplement enforcement, what we’re looking for, especially when we’re going to enforce criminal charges, is clear conduct that has a public health as-pect to it,” he said.

Imports of substances purported to be dietary ingredients is a CPB focus cur-rently. That’s partly because drug-spiked supplements are available in myriad retail channels, even though infrequently at




mainstream retailers, and the DoJ, like the FDA, has limited staff-ing. “Playing the game of whack-a-mole with dietary supplements companies in the United States who are buying these products and selling them by and large is difficult to play,” Runkle said.

With online sales rampant and countless one-store businesses offering supplements from suppliers that, intentionally or not, are noncompliant with FDA regulations, “it’s difficult to make a whole lot with that,” he said.

A common result is a plea of ignorance by businesses FDA in-vestigators find to have drug-spiked supplements, he added. “They really don’t even know what’s in there. They might suspect that something’s wrong, but the evidence isn’t really there to show that they know it was adulterated.”

RESOURCES FACTOR IN INVESTIGATION DECISIONSSimilarly, supplement GMP violations won’t generate DoJ action unless a firm repeatedly fails to become compliant while continu-ing to make or sell products.

“I haven’t seen a case where I’m going to just say, ‘OK, this plant is so dirty we’re going to go criminal on this’,” Runkle said.

CPB decisions on GMP violations complaints, like others the FDA may have, are influenced heavily by DoJ resources, he added. A small business found selling spiked supplements, for instance, probably isn’t going to be targeted by the DoJ.

“I don’t know in my practice that that’s the best use of my resources because I think there are a number of cases out there and there’s a lot more enforcement that can be done on im-porters, the people who are actually importing the substance,” Runkle said.

And on supplement GMP compliance, CPB acknowledges that the FDA finds many violations. “In terms of the regulatory world, yes FDA needs to be out there making those cases and doing, I think, many more injunction cases against dietary contract manu-facturers that aren’t doing ingredient testing,” he said.


‘Supplement’ On CBD Product Label A Bullseye For US Litigants, Says AttorneyEILEEN FRANCIS [email protected]

Companies selling cannabiniod-containing products adver-tised as supplements or bearing a Supplement Facts label are at higher risk of being targeted in complaints for dam-

ages, suggests food and drug attorney Frederick Ball.At least hundreds of CBD-containing products have been sold

in the US over the past few years without spurring attention from litigants, but warning letters the US Food and Drug Administra-tion recently sent to 15 CBD marketers – most identifying supple-ment labeling as problematic in addition to unsupported claims – likely will stir things up, suggested Ball, a partner at Duane Mor-ris LLP in Boston, during a Food and Drug Law conference on 12 December in Washington.

Two of the companies the FDA warned in November – Infi-nite Product Co. LLC and KOI CBD LLC – were named in pend-ing class action suits filed in US Circuit Court for the California Central District. Other companies that received FDA warnings about CBD separate from the November blitz and some that have not received warnings also are targeted in complaints from consumers seeking damages and alleging their products are illegal and unsafe

Notably, class action litigations seem to be seizing not only on unsupported claims cited in FDA warning letters, but also that the agency identified products as falsely labeled as dietary supple-ments or containing a Supplement Facts label.

In the 15 warning letters FDA sent on 25 November, it noted CBD is excluded from being used as a dietary ingredient under FDA regulations because it was approved as an active drug in-gredient in 2018 and previously was studied as a drug. The letters also focused on companies making structure/function or disease-treatment claims that render the products as unapproved drugs.

(Also see “FDA Warns 15 CBD Product Marketers For Violations, Cau-tions Consumers: CBD May Harm You” - HBW Insight, 27 Nov, 2019.)

In October, the FDA and the Federal Trade Commission filed a joint warning letter against Rooted Apothecary LLC, a firm mar-keting CBD-containing pain relief products for teething babies and children. The agencies said the firm mislabeled its products as dietary supplements due to the presence of CBD.

The FDA has targeted CBDs in supplements since at least 2016, when it sent warning letters to six firms making disease claims for products. Those letters noted that because CBD had been used in an investigational new drug study, it was unlawful for use in supplements. Prior to that, FDA had not issued any warning letters to companies taking issue with CBD oil as a dietary ingredient or food, according to food and drug law attorneys.

The FDA has made clear since it approved the first, and so far only CBD-based drug in July 2018 that while the substance is un-lawful as a dietary ingredient, the agency will target firms market-ing CBD-containing supplements with disease claims.

WAKE-UP CALL TO MARKETBall said he continually urges his clients not to label or market their CBD products as supplements. Statements he FDA and the FTC included in warning letters explaining that CBD is unlawful for use in supplements vindicates his position, he said.

He also notes his advice runs counter to the positions of other industry lawyers and consultants who advise companies to follow all dietary supplement labeling requirements for CBD products.

“Do not label the products as ‘supplements’ or ‘dietary supple-ments.’ Do not use the supplement facts panel. Have a lawyer re-view your label and promotional material for potential hot button




issues with the FDA, FTC and state agen-cies,” Ball told HBW Insight.

Additionally, he advises companies to keep track of their websites and other sites that may sell their products to ensure false claims are not posted.

Ball says the spate of warning letters and the lawsuits should be a wake-up call to other CBD marketers making noncom-pliant claims that they can no longer sim-ply claim ignorance.

“It is impossible for anyone in industry to claim they didn’t know. At this point they’re being willfully ignorant. All the person suing needs to do is point to the warning letter and the 40 other warning letters [already sent to CBD marketers] and say, ‘you had to know’,” Ball said at the FDLI conference.

AT LEAST FOUR CLASS ACTION CBD SUITS NEWLY FILEDThe lawsuit seeking class action certifica-tion were filed against Infinite Product on 27 November, two days after the Lake-wood, CA, firm received its FDA warning letter. Another one was filed on 3 Decem-ber against San Diego-based CV Sciences

Inc., which did not receive an FDA warn-ing but manufactured products for two companies that received warning letters in 2016, according to the complaint.

The complaint against Infinite Product was filed by a California resident who cited the FDA warning letter and argued the firm marketed products with disease-treatment claims and that the formulas were “illegal to sell” because they were marketed as dietary supplements but contain CBD, a “mislabeled drug.” The plaintiff, who cited false advertising, un-fair competition and warranty claims, was represented by Kohn, Swift & Graf PC in Philadelphia, Barbat, Mansour & Suciu PLLC in Bloomfield, MI, and Greg Coleman Law Firm, Knoxville, TN.

The plaintiff identifies products including Infinite Product’s Absolute Zero 99%+ CBD Isolate and Afterglow Healing Oil 100mg CBD Total. He points to the FDA warning letter citing claims the products could treat the symptoms of diseases including cancer, diabetes and hepatitis and could also serve as an alternative to opioids.

The consumer seeks damages in excess of $5m on part of the entire class of con-sumers in the US who purchased the firm’s products, the suit says. Alternatively, he re-quests a sub-class of California consumers who purchased the products.

A similar suit was filed by the same law team 5 December against Koi CBD LLC, a Norwalk, CA, company that mar-kets namesake brand gummies, tinctures vape oils and soft chews. Consumers from Arizona and California who filed the com-plaint allege misleading claims, including that the products fight brain cancer cells, diabetes and opioid addiction. They also argue the products are illegal to sell as supplements.

The suit seeks to represent a nationwide class of consumers who purchased the products or as an alternative, consumers in Arizona and California, with at least $5m in damages sought.

The same lawyers represented consum-ers in a complaint against CV Sciences, claiming it sold “illegal CBD products” in-cluding sprays, oil drops and gummies. “Every product contains a Supplement Facts section on the back of the container which is reserved for dietary supplements and explicitly state ‘Dietary Supplement’ on the front of the packaging,” the com-plaint states.

The consumers bring the case on be-half of all US consumers who purchased the products or a sub-class of Arizona and California residents. They seek at least $5m in damages.

Other complaints have been filed against CBD firms unrelated to the No-vember warning letters. On 2 December, Boulder, CO-based Charlotte’s Web Hold-ings, Inc. – one of the largest US CBD prod-uct marketers – released a statement that it was aware of a “yet-to-be-served” class action suit filed in the Northern District of California alleging its products are misla-beled as dietary supplements.

The firm, which has not received a warn-ing letter from FDA, sells CBD tinctures, capsules and topicals. The company says it believes its products are “accurately labeled and that the claims are without merit” and will “vigorously” defend itself against any such suits.

In California and New York, consumers have filed complaints claiming they pur-chased CBD products claiming to be “THC free” or to contain “0 THC” and that they were later terminated from their employ-ment after testing positive for the ingredi-ent. Industry attorneys have been warn-ing CBD and hemp firms, urging them to develop a strategy for thoroughly vetting ad claims and anticipating a wave of litiga-tion. (Also see “CBD Suits Challenge ‘THC-Free’ Claims After Users Fail Drug Tests; Plaintiffs Bar May Just Be Warming Up “ - HBW Insight, 22 Aug, 2019.)


Frederick Ball: “It is impossible for anyone in industry to claim they didn’t know” about FDA’s CBD policy.

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‘No B.S.’ In RxBar Package-Front Claims, Advertising Self-Regulation Forum FindsEILEEN FRANCIS [email protected]

The simplicity of the RxBar protein bar package front isn’t misleading with a list of the numbers of egg whites, al-monds, cashews and dates used in each bar followed by

“No B.S.”, a Council of Better Business Bureau industry self-regula-tion unit decides on a challenge by Kind LLC.

“It is common for food products to tout ingredients on their

labels without specifying their relative prominence by weight, volume, or any other measure within the product,” attorneys for the National Advertising Division in the council’s BBB National Programs Inc. said in a report published 11 December analyzing claims for the clean-label protein brand product marketed by In-surgent Brands LLC, a division of Kellogg Co.

Can Synthetic CBD Overcome Cannabis Stigma And Break EU Novel Foods Deadlock?TOM GALLEN [email protected]

European Union regulators’ slow progress on authorizing cannabidiol derived from Cannabis sativa L. for use in di-etary supplements has prompted a Czech Republic-based

manufacturer to seek approval for synthetic CBD as a novel food. The firm believes intransigence on the part of regulatory authorities may be caused by the stigma attached to cannabis-derived CBD, a stigma which it says a synthetic product has the potential to overcome.

The manufacturer, CBDepot, is a subsidiary of Cannabis Phar-ma, the first company to lodge a novel food application with the European Food Safety Authority for cannabis-derived CBD.

“By filling an application for authorization of synthesized canna-bidiol, CBDepot hopes to lift the legal prejudices on this molecule based on its source,” the company said in a statement. CBDepot claimed cannabis-derived CBD had been to date treated unfairly be regulators. “[The firm] believes the source of a chemical substance does not matter in its assessment of legality, provided it was manu-factured according to legal requirements in the country of origin.”

NO DETECTABLE THCCBDepot’s application to place on the EU market trans-cannabidi-ol manufactured by chemical synthesis as a novel food ingredient has been logged in EFSA’s Register of Questions, the first step on the path to approval. The synthetic ingredient is manufactured to guarantee a trans-cannabidiol with a minimum 99% purity and no detectable tetrahydrocannabinol (THC), according to the novel food filing, and is intended for use as a supplement by the healthy adult population excluding pregnant and breastfeeding women.

While admitting the use of synthesized trans-cannabidiol in foods and food supplements has not yet been documented, CB-Depot claims in its application that there is evidence to suggest that intake of CBD “results in well-being, feeling fitness and ho-meostasis in general.”

Cannabis Pharma’s original application for CBD as a novel food was filed back in 2016 through the Czech Ministry of Agriculture,

and re-filed in early 2018 with EFSA, which logged the application in the Register of Questions in June of that year.

COMMISSION DRAGGING ITS HEELSAccording to CBDepot, EFSA deemed the dossier as “suitable” for the novel food pathway in July 2019, but the European Commission is yet to give the go ahead for its review. “This is the reason ESFA has not started a risk assessment of this appli-cation,” the firm claims.

Under Regulation (EU) 2015/2283 on novel foods, centralized, safety evaluations of applications are carried out by EFSA. The Commission consults EFSA on the applications and bases its au-thorization decisions on the outcome of the agency’s evaluation.

Novel food applicants can request data protection for their sub-mission – which can last up to five years – meaning CBD firms will likely have to make individual applications to EFSA.

“All novel foods are closely linked to the process of extraction or production,” consultant Janet Worrell told HBW Insight earlier this year. “A novel food application needs to provide data on the speci-fication of the product, its production process, use and intakes, nutrition, microbiology, toxicology and allergy information.”

Under the regulation, each production process results in a dis-tinct approval, which is then valid across all EU member states.






“For example, food products will promote flavor ingredients by order of importance to the flavor profile but not weight or high-light an ingredient that is nutritionally beneficial that is not the most prominent ingredient in the product,” they added.

New York-based Kind, which markets namesake brand meal-replacement bars, challenged RxBar front-of-package claims, including arguing that the whole, protein-rich ingredients in the product are “3 egg whites,” “6 almonds,” “4 cashews” and “2 dates.” The FOP label, which ends with “No B.S.”, is notable for its simple design with the brand printed in color in a white box over a single-column list printed in white and each flavor in a differ-ent color package.

Kind contended “3 egg whites” at the top of the list conveyed that whole egg whites are the most prominent ingredient in the product, even though it is egg white powder. It also contended RxBar is 60% date paste, accounting for a bigger portion of the bar then the eggs or nuts that were listed above the reference to dates.

Kind also asserted the FOP ingredient list would appear to con-sumers similar to the ingredient statement required by the US Food and Drug Administration on the back label, further sending the wrong message about the presence and quantity of ingredi-ents in the products.

Additionally, it argued the “No B.S.” at the end of the list can in-dicate to consumers that no other ingredients are used in the bar.

EGG POWDER CAN BE LISTED AS ‘EGG WHITE’In support of its position, Kind submitted a survey of more than 1,600 consumers of nutrition and snack bars shown the FOP of one of two RxBar products, or one of three control images for either bar. It said the survey demonstrated consumer confusion over the contents of the bar. For example, 65% of respondents for one bar though an ingredient other than dates is the most domi-nant in the bar, the challenger pointed out.

However, NAD attorneys determined the survey had “signifi-cant” flaws and did not support KIND’s argument the RxBar label

conveys the unsupported message that dates are not the most prominent ingredient in the bars. “Many of the central survey questions were vague, such that they did not elicit clear answers from the respondents” and the “substantive” portion of the survey featured open-ended questions, according to the report.

NAD attorneys evaluated the case without considering the sur-vey results as evidence.

Addressing Kind’s claim that consumers would believe the RxBar products contained three whole egg whites, NAD attorneys said no evidence supported that position. Each bar contains three egg whites, but dried, similar to nuts being crushed or ground into a butter and dates turned into a paste to use in the bars, they stated.

“FDA regulation allows dried egg whites to be referred to as ‘egg whites’ on a product ingredient list,” the attorneys said, noting that NAD harmonizes its standards with relevant regulatory guidance.

Consumers likely will view the simple claims stated in terms they understand and will not extrapolate meanings about weight and proportions of the protein bar inside, they stated.

“NAD determined that this straight forward, literal message is supported and that the proportions of ingredients in the bar do not contradict the message conveyed by the label.”

The attorneys had no problem with the “No B.S.” claim on the label. Insurgent’s explanation that RxBar uses “recognizable ingre-dients that are readable and understandable” provided a reason-able basis for the message, they said.

In its response included in the NAD report, Chicago-based In-surgent said the RxBar brand “was founded on the principle that a protein bar could be made with real, simple ingredients, a mes-sage we hope to convey with our product packaging.” The firm added that NAD attorneys “appropriately and thoughtfully deter-mined that consumers understand the claims on our packaging.

Kellogg added the RxBar brand in 2017 when it firm acquired parent company Chicago Bar Co. LLC for $600m and changed the business’ name to Insurgent Brands.


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