The Current State of Global Cosmetic

Regulations

David C. Steinberg, FRAPSSteinberg & Associates, Inc.

November 19, 2013

FDA ◦ Cosmetic◦ Drugs

FTC◦ Advertising claims

EPA◦ Volatile Organic Compounds (VOC’s)

State Issues◦ California

Proposition 65 Safe Cosmetic Act Green Chemistry

◦ Minnesota Global Issues

◦ EU◦ Canada

Who Regulates Cosmetics in the United States?

Your customers◦ Many retail outlets are now banning ingredients

Or their customers?◦ Consumers, lead by scare tactics, are demanding

companies remove ingredients Or the internet blogs?

◦ They have now replaced the press as the major outlet for junk science

Or

Cosmetics must be safe

Cosmetics must be properly labeled

Cosmetics must make only cosmetic claims

General FDA Regulations

Warning lettersProhibit product importationInspectionsSeizures (Recalls of Cosmetics and Monographed OTC drugs are voluntary)

Injunctions Criminal sanctions and fines[ FDA does not have independent litigating authority so seizures, injunctions and criminal proceedings are all processed by going through the Justice Department]

Enforcement Of FDA Regulations

• Can take actions only if a product is adulterated or misbranded

• In 2011, they sent out 1 warning letter for cosmetic adulteration: Brazilian Blowout

• Other cosmetic warning letters focused on adulteration or misbranding based upon the making of “drug claims”.

FDA-Cosmetics

• Very active in sending out Warning letters for unapproved or miss-labeled drugs. Cosmetic part works in conjunction with the Drug part. They have also requested voluntary recalls.

• Examples or unapproved drugs: Minoxidil with accelerators or products that claim hair growth and do not have a NDA or ANDA, Vagifresh Ball and Vagifresh Gel with benzocaine, Anti-bacteria lotions claiming anti-viral activity against H1N1

• Internet web sites are triggering many warning letters

FDA-Drugs and Cosmetics

Custom holds

Send out for testing

Place you on their “watch” list

Customs

Unapproved colors

Microbial contamination

Incorrect Labels

Unregistered drugs

VOC violations

Major Reasons

Colors that are not allowed in cosmetics in the US Colors that are not allowed in that type of

cosmetic-eye area, lips, etc. Colors not labeled correctly –using CI numbers as

opposed to US names Carmine and non-approved colors or chemicals

listed in “May Contains” section; also listing here colors not permitted for this use

Colors not being batch certified if required Colors not meeting self certification

requirements.

Unapproved colors

The FDA can take samples at Customs for microbial plate counts and identification of microbes

Can declare products adulterated if contaminated.◦In 2011, they declared Bacillus cereus as opportunistic pathogen at levels of 1 cfu/g!

Microbial Contamination

Not having correct disclosure or location of net contents

Incorrect ingredient listings, especially incorrect listing of colors failing to use US names

Country of origin Warnings

Non Compliant Labels

Aqua◦ Water

Natural glycerin◦ Glycerin

Organic Sesame seed oil◦ Sesamum Indicum (Sesame) Seed Oil

Vitamin E (Tocopherol)◦ Tocopherol

Only Colour Index Numbers◦ Blue 1 (CI 42090) or CI 42090 (Blue 1)

Incorrect Ingredient Listings Examples

Requires full US address on the label◦ Street and number may be omitted if the name is

located in the phone directory of the city listed◦ Do they still make phone books?◦ They never heard of 800 numbers, email or

websites◦ Will they ever join the electronic age?

Fair Packaging & Labeling Act

Located on lower 30% of label You can have both Metric and English units Correct Abbreviations mL, g, Oz., Fl.Oz. All Drugs (including OTC) must be labeled in

Metric Only 2 other countries-Liberia and Myanmar

still use the English system The US is officially a Metric country!

◦ Law passed in 1867 established this and was never rescinded

Net Quantity or Contents

• Sunscreen labeled as cosmetics– Simply saying SPF or contains sunscreens, makes you a

drug unless covered by qualifying terms i.e. for hair protection

• Not in FDA’s data base as having been properly registered– Labeler code, site license, product registration, US based

FDA liaison. • Lack of Drug Facts labels• Lack of compliance with PL 109-462– A way for consumers to report serious adverse reactions(

must be in US)• Drug claims for cosmetics– Anti-aging claims are frequently held by customs

Unregistered Drugs

EPA requirements

California

VOC Violations

Hair Mousse, shines, gels, styling products, sprays

Nail polish remover Fragrances Shaving creams and gels Temporary aerosol hair colors Antiperspirants Astringents Deodorant body sprays

Cosmetics Regulated under VOC Regulations

Latest change is labeling carmine◦ Must be on all labels◦ Cannot be a “may contains” ingredient

Only in US-causing harmonization issues

New Federal Regulations???◦ Several Bills Submitted◦ Mostly EWG promoted◦ Not going anywhere

Talks between industry & FDA have not been successful

Latest Changes to FDA Regulations of Cosmetics

House leader of the sub committee will only accept a bill that both industry and FDA will agree to (not the EWG!)◦ FDA wants user fees

Industry may accept if only used for cosmetics◦ Industry wants Federal Preemption

California, Minnesota Calendar issues

Why?

2013-budget and debt ceiling 2014-silly season for House and 1/3 of Senate 2015-silly season for President (it has already

started!) 2016-silly season for President and Congress 2017-earliest I think Congress will consider any

action

General thought-more important issues for Congress than cosmetics◦ PS: Do you trust Congress?

Calendar

State of California

Proposition 65 is a requirement to warn if your product contains a chemical that the State has deemed to cause cancer or reproductive harm

New cosmetic chemical additions◦ Methanol◦ Benzophenone (note only Benzophenone not Benzophenon with a

number)◦ Cocamide DEA◦ Titanium Dioxide

Current issues◦ Acrylamide for reproductive toxicity now has a Safe Harbor limit and

is no longer an issue◦ DEA content in TEA, MEA, amides

Proposition 65

The California Safe Cosmetic Act of 2005

Titanium dioxide Black 2 Retinol or its esters BHA Cocamide DEA Methanol Formaldehyde

solutions

Benzophenone Coffee extract Diethanolamine

You are Required To Register Your Product if it Contains As an Ingredient

There are 700+ chemicals but few other than those listed are used.

No distinction between cosmetics or drugs that also make cosmetic claims.

Name of company on the label is who must register.

No minimum levels, only detection is needed.

No money to enforce but is being cited in Prop 65 law suits.

Other Ingredients

The California lawyers who thrive on Prop. 65 lawsuits, are now filing false advertising suits under the California Consumers Legal Remedies Act.

As with Prop 65 letters, the goal is to force settlements as quickly as they can by threatening major litigation

Lawyers

Identify and prioritize chemical ingredients in consumer products that may be chemicals of concern, and to determine how best to limit or reduce the potential hazards posed by such chemicals.◦ Exempted: Foods, prescription drugs, insecticides

Will identify "candidate" chemicals of

concern and identify and prioritize products containing candidate chemicals.

California’s Green Chemistry

Must analyze alternatives to eliminate or reduce potential exposure to chemicals of concern in priority products.

Prohibiting the sale and distribution of the product in California.

11/1/13 Post List of Chemicals

4/1/14 Priority List of 5 Chemicals

10/1/14 Proposed Candidates

12/1/14 Companies must notify the DTSC

12/1/15 Compliance required

Department of Toxic Substances Control(DTSC)

Aluminum (includes powder) D-4: Cyclotetrasiloxane DEA D-6: Cyclohexasiloxane Formaldehyde Methyl Alcohol Parabens Toluene

Candidate List – Used in Cosmetics

Proposition 65 requires you to warn

Safe Cosmetic Act requires you to register

Green Chemistry can force you to remove your product

Summary

Minnesota

Passed 5/13/13 Prohibits formaldehyde, or

formaldehyde releasers from children's products as of 8/1/14

Children are defined as under 8 years Cannot replace in cosmetics this with

any chemical known or suspected to:

HF 458

Development toxicity Cause cancer, genetic damage or reproductive harm

Disrupt endocrine or hormone system

Damage nervous system, immune system, or cause systemic toxicity

Suspected (continued)

• Limited problems for anhydrous products or emulsions

• And no known preservatives that work in surfactant based cleansers.

• What about traces of HCHO found in fatty alcohols which are the base for all surfactants and esters?

Leaving

Diazolidinyl Urea Imidazolidinyl Urea DMDM Hydantoin Quaternium-15 Sodium Hydroxymethylglycinate Methenamine* 5-Bromo-5-Nitro-1,3-Dioxane* 2-Bromo-2-Nitopropane-1,3-Diol*

*rarely used

Formaldehyde Releasing Preservatives

• Your retail customers are now requiring you to comply with their rules on product substantiation claims and ingredients.

• These include QVC and HSN; Wal-Mart, Boots, Whole Foods, Target and the trend is growing.

• Why?– The constant attacks by you against your

competitors who use “bad” ingredients, which, of course, you label as “Free”; has convinced stores to prohibit the use of many ingredients which are safe and confirmed to be safe by independent experts and the FDA.

Companies

Can you make us a cosmetic line without any: Parabens, Alkyl or Alky Ether Sulfates, Petrochemicals, Carmine, tallow?

Well I guess we can make vegetable soap and use vegetable oils as emollients; soap emulsifiers (and GMS) and thicken them with natural gums, but we can’t preserve any products and they will stink without any antioxidants and fragrances!

Formulating Request From One Company

• Possibly Federal Legislation to require the FDA to pre-approve your products and all ingredients.

• This is the goal of many NGO’s

• This will kill innovation and new products

• You can then claim innovation free!

The Final Result

European Union

European UnionUnited Kingdom Malta Sweden

Denmark Cyprus Austria

Ireland Estonia Finland

France Bulgaria Czech Republic

Germany Luxembourg Latvia

Italy Netherlands Lithuania

Belgium Greece Slovakia

Poland Spain Slovenia

Hungary Portugal Romania

Croatia

CzechEstonianGermanLithuanianSlovakDutchFinnishItalianPolishSpanish

DanishGreekHungarianMalteseSloveneEnglishFrenchLatvianPortugueseSwedish

Official Languages

Norway, Iceland, Lichtenstein

Switzerland

Most of Middle East, South Africa, Latin and South America China and Asean Countries

Not Members but follow the Rules

The Cosmetic Directive 76/768/EEC

8th Amendment 2013 changes this to a regulation

40 Articles

10 Annexes

European Regulations

Must have an EU addressMust have a Responsible PersonMust have a Product Information Package

Must be RegisteredMust have correct labelingMust be compliant with REACH

Short Version

You may put this symbol on the net contents line by voluntarily complying with the EU regulations for average fill.

The US is a minimum fill country. By placing this on your product, you admit to violating our regulations!

This mark only impacts intra European shipments and now has little value.

Placing this mark on your label and not complying results in severe penalties in the EU.

Minimum type size makes it look ugly!

Estimated Symbol

℮

Sometimes called the “e” mark

Type of Product Qualitative Formulation Adverse health affects Quantitative amounts of “Dangerous

Substances”

Consumers Right to Know

Canada

Prior to or within 10 days of first sale, all cosmetics must be registered in Canada by filing a Cosmetic Notification Form with Health Canada.

Electronic version called CosMOS is now available

Registration of Cosmetics

Very user friendly

Integrated with INCI Dictionary

Can’t submit incorrect forms

Hot list and DSL are also integrated

Can check status

Previous submissions will be uploaded automatically

On Line Cosmetic Notification

June 2010 Health Canada issued new lists of acceptable cosmetic claims and claims that make you a drug.

They are listed by Substrate, Product or Claim

Clearly spell out what is a cosmetic claim and what is a drug claim

Advertising and Labeling Claims

Ingredients that are prohibited or restricted in cosmetics.

Ingredients are added and can be removed at any time.

Latest Changes are June 2010. New Proposals are open to current public comments

Hot List

Competition Bureau and Advertising Standards consider “free” claims to be false and misleading.

Example: dynamite free

They have issued conditions which must be met to make such a claim

Critical New Rules on Advertising

The product must have contained this ingredient and was on the Canadian market with established registrations and dates.

The Government must be notified that you removed this ingredient.

Outside analysis must show that ZERO amount of this ingredient can be detected

You are than allowed to make the claim…..free for only 1 year.

At the end of 1 year, all products must be removed from the shelf.

Conditions for “free” Claims

• This product was never formulated with dynamite

• This product naturally contains no dynamite

• We do not have dynamite in this product

• However all of these claims must be true and provable.

What You Can Say

Domestic Substance List◦ All ingredients must be on the DSL or In

Commerce list◦ If not, they are subject to New Substance

Notification Regulations◦ Threshold is 100 kg/year in Canada

Environment Canada

The US is still the best place to introduce new ingredients and cosmetics!

The US will soon be the only country to regulate sunscreens as drugs!

European regulations make Japanese regulations look easy!

Harmonization of regulations will never happen!

Read my next (and last) column in Cosmetics & Toiletries magazine on how I think cosmetics should be regulated.

Conclusions

davidpreserve@comcast.net

Questions?

Thank You!