us product labeling guide (josef brinckman)

8/3/2019 US Product Labeling Guide (Josef Brinckman)

1/45

Product Labeling Guide

for Biodiversity Productsin the United States Market

By: Josef Brinckmann, ITC ConsultantDate: 26September 2011


2/45

The Main Points.

What are the FDA labeling rules for health foods, herbal dietarysupplements, herbal homoeopathic drugs and natural cosmetics?

Natural ingredients that can be used in cosmetic, dietary

supplement, drug or food products (e.g. Capsicum Fruit or CocoaButter) and the differences in labeling requirements.

USDA labeling rules for certified organic product labels.

Importance of certifications for natural products to increasemarket chances: ecological (Biodynamic or Organic), religious(Halal or Kosher) and social (FairTrade or FairWild.

2


3/45

Why is this information important andwho should study it?

U.S. labeling regulations are complicated and easy to get wrong.

Our analysis shows that exporters from Latin America often havetheir products held up or refused entry for labeling violations.

This labeling guidance will help exporters of finished naturalproducts to better understand the labeling rules for different typesof products in the U.S. market.

ITCs U.S. Labeling Guide should be studied by your responsibleperson(s) for Legal and Regulatory Compliance as well as yourfirms managers of International Sales and Marketing.

3


4/45

Types of Labels

In the United States, finished natural products could fit into anumber of different regulatory frameworks, depending on theircomposition, dosage form, and intended use(s), each with their ownunique product labeling requirements and different GMP rules.

The FDA enforces different labeling regulations for:cosmetic products: non-drug and drug cosmetics

food products: conventional foods, foods with health claims,foods for special dietary use, herbal dietary supplements, andmedical foods

drug products: over-the-counter (OTC) conventional drugsincluding botanical drugs and herbal homoeopathic drugs, andprescription (Rx) drugs

4


5/45

Types of Labels

5


6/45

VoluntaryCertification and Labeling Schemes

Of increasing importance for natural products are labels showing seals:

Ecological Certification (Demeter Biodynamic ; NOP Organic)

Religious Certification (OK Kosher and IFANCA Halal); and

Social Certification (IMO Fair for Life; FLO FairTrade; FWF FairWild)

6


7/45

Labeling RequirementsNon-drug Cosmetics

The following information must appear on the Principle DisplayPanel (PDP) of a non-drug cosmetic product:

An identity statement, indicating the nature and use of the

product, by means of either the common or usual name, adescriptive name, a fanciful name understood by the public, or anillustration representing the intended cosmetic use. The statementof identity must be shown in bold type and be in a size reasonablyrelated to the most prominent printed matter on the PDP.

An accurate statement of the net quantity of contents, in terms ofweight, measure, numerical count or a combination of numericalcount and weight or measure.

7


8/45


The following information must appear on the Information Panel of anon-drug cosmetic product:

Name and place of business. This may be the manufacturer,

packer, or distributor. Distributor statement. If the name and addressare not those of the manufacturer, the label must say "Manufacturedfor..." or "Distributed by...

Material facts. Examples include adequate directions for safe use,

if a product could be unsafe if used incorrectly. Other examples ofmaterial facts include risk statements (e.g. cautions,contraindications, known side effects, warnings).

8


9/45


The following information must appear on the Information Panel of anon-drug cosmetic product:

Warning and Caution statements (when necessary) must appear

on the Information Panel of the cosmetic label prominently andconspicuously as compared to other words, statements, designs, ordevices and in bold type on contrasting background so that theordinary person can easily read and understand it.

The Ingredients of the product must appear on the InformationPanel of the cosmetic label prominently and conspicuously indescending order of predominance

9


10/45

Labeling RequirementsFood Products

Each different type of food product has different labeling rules:

Conventional foods: including healthy food products eligible forapproved health claims or qualified health claims labeling;

Dietary supplements: regulated as a subset of food regulationand eligible for approved health claims, qualified health claims,and/or structure / function claims labeling;

Foods for special dietary use: hypoallergenic foods, infant foods;

Medical foods: formulated to be consumed or administered under

the supervision of a physician - intended for the specific dietarymanagement of a disease or condition with distinctive nutritionalrequirements.

10


11/45

Labeling RequirementsConventional Food Products

The following information must appear on the PDP of a conventionalfood product (including health foods or functional foods):

Statement of identity, indicating the common or usual name of the

food and its form (e.g. whole, slices, diced, etc). The statement ofidentity must be shown in bold type and be in a size reasonablyrelated to the most prominent printed matter on the PDP.

Declaration of net quantity of content, expressed in the terms of

weight, measure, numerical count, or a combination of numericalcount and weight or measure. The statement must be in terms offluid measure if the food is liquid, or in terms of weight if the food issolid, semisolid, or viscous, or a mixture of solid and liquid.

11


12/45


This information must appear on the Information Panel of a food(unless all essential information already appears on the PDP).

Designation of ingredients: Food ingredients must be listed by

their common or usual (American English) name in descendingorder of predominance by weight .

Name and place of business of manufacturer, packer, ordistributor. If the food product is not manufactured by the business

or person whose name appears on the label, the name must bequalified by a phrase that reveals the connection between thatcompany and the product; such as Manufactured for ___,Distributed by ___, or any other similar wording

12


13/45



Country of origin statement must be conspicuous. If a U.S. firm's

name and address is declared as the firm responsible fordistributing the product, then the country of origin statement mustappear in close proximity to the name and address and be at leastcomparable in size of lettering.

Nutrition labeling. Required nutrition labeling information mustappear on the Information Panel in the Nutrition Facts box format.

13


14/45



Nutrient content claims (high in antioxidant vitamin C or good

source of fiber) are permitted under certain conditions on labels offood products that meet the requirements. These statements mustappear on either the Information Panel and/or the PDP.

Material facts. For example directions for safe use, if a product

could be unsafe if used incorrectly. Other examples of material factsinclude risk statements (e.g. cautions, contraindications, knownside effects, warnings)

14


15/45



Warning and Caution statements (when necessary for safe use)

must appear on the Information Panel or PDP of the food labelprominently and conspicuously.

Allergy labeling (Contains statement). All packaged foodproducts must comply with the food allergen labeling requirements

of the Food Allergen Labeling and Consumer Protection Act of2004 (FALCPA). Under FALCPA, major food allergens must belisted on the Information Panel in a Contains statement. Forexample: Contains Brazil nuts.

15


16/45

Example of Nutrition Facts BoxFormat Requirements

16


17/45

What About Bilingual Labels?

Label text must be in English except in the Commonwealth of

Puerto Rico where the labeling may be presented in Spanishlanguage (or in bilingual labeling) or in other U.S. territories wherethe predominant language is one other than English.

Bilingual labels are permitted in the U.S. market so long as all ofthe required elements are provided in both languages (e.g. in bothEnglish and Spanish).

Chamorro language could be used on product labels in theAmerican territory of Guam and in the U.S. Commonwealth of theNorthern Mariana Islands. Hawaiian is an official language of theState of Hawaii and could be used in bilingual labeling with English.

17

18


18/45

Example of Acceptable BilingualNutrition Facts Labeling

18

19


19/45

Labeling RequirementsDietary Supplement Products

The following information must appear on the PDP of a DSP:

The statement of identity is the common or usual name of thedietary supplement or an appropriately descriptive term. The term

"dietary supplement" must be used as part of the statement ofidentity, except that the word "dietary" may be replaced with thename of the dietary ingredient(s) (cats claw supplement) or anappropriately descriptive term indicating the type of dietaryingredient(s) (herbal supplement).

The net quantity of contents statement must be located as adistinct item in the bottom 30% of the PDP. Both metric (grams,kilograms, milliliters, or liters) and U.S. Customary System (ounces,pounds, or fluid ounces) terms must be used.

19

20


20/45

Permitted Structure/Function StatementsDietary Supplement Labeling

Dietary supplement labels may bear statements that describe therole of a nutrient or dietary ingredient intended to affect thestructure or function in humans or that characterize the documentedmechanism by which a nutrient or dietary ingredient acts tomaintain such structure or function, provided that such statementsare not disease claims.

If the label of a dietary supplement product bears a disease claim,the product will be subject to regulation as a drug unless the claimis an authorized health claim for which the product qualifies.

20

21


21/45

Required Disclaimer StatementDietary Supplement Labeling

Each structure / function claim statement appearing on a DSP labelmust be followed by an asterisk * which refers to the requiredDisclaimer Statement shown on the same panel of the product label:

*These statements have not been evaluated by the Food and DrugAdministration. This product is not intended to diagnose, treat, cure,or prevent any disease.

The disclaimer must appear on every panel of the label where aclaim is made. The disclaimer can be placed adjacent to the claim orset off in a box when it is not placed adjacent to the claim statement.

21

22


22/45


This information must appear on the Information Panel of a DSP:

The Supplement Facts Box must appear as specified in theregulation 21CFR 101.36: Nutrition labeling of dietary supplements.

Designation of ingredients: The common name of ingredients ofdietary supplements that are botanicals (including fungi and algae)must be consistent with the names standardized in the AmericanHerbal Products AssociationsHerbs of Commerce. The part of the

plant (e.g., root, leaf) (e.g., Cats claw bark or Cats claw (bark))is required except for algae. The name of the part of the plant mustbe expressed in English (e.g., flower rather than flos).

22

23


23/45


23

24


24/45


The following information must appear on the Information Panel of aDSP (unless all essential information already appears on the PDP):

Name and place of business of manufacturer, packer, or

distributor. The street address, city, state and zip code must beshown. If the dietary supplement product is not manufactured by thebusiness or person whose name appears on the label, the namemust be qualified by a phrase that reveals the connection betweenthat company and the product; such as Manufactured for ___,

Distributed by ___, or any other similar wording.

24

25


25/45



Country of origin statement must be conspicuous. If a U.S. firm'sname and address is declared as the firm responsible fordistributing the product, then the country of origin statement must

appear in close proximity to the name and address and be at leastcomparable in size of lettering.

Material facts. An example is directions for safe use, if aproduct could be unsafe if used incorrectly. Other examples of

material facts include risk statements (e.g. cautions,contraindications, known side effects, warnings).

25

26


26/45



Warning and Caution statements (when necessary for safe use)must appear on the Information Panel or PDP of the dietarysupplement label prominently and conspicuously. Certain dietary

supplements require specific statements defined in regulation.

Allergy labeling (Contains statement). All dietary supplementsmust comply with the food allergen labeling requirements of theFood Allergen Labeling and Consumer Protection Act of 2004

(FALCPA). Under FALCPA, major food allergens must be listed onthe Information Panel in a Contains statement. For example:Contains Ginkgo Nuts.

26

27


27/45

Labeling RequirementsHerbal Homoeopathic Drug Products

Most U.S. Health Food and Natural Food Stores as well asPharmacies stock a good range of herbal homoeopathic drugs,often placed right alongside herbal dietary supplements.

Most homoeopathic medicines are labeled as over-the-counter

(OTC) drugs and some are available by doctors prescription (Rx)only. As such, OTC homeopathic drug products are subject to nearlythe same labeling requirements as for conventional drug products.For example, they must bear a DRUG FACTS box.

Products labeled as homoeopathic drugs are subject to theprovisions of the Homoeopathic Pharmacopoeia of the UnitedStates (HPUS) and not to those of the United States Pharmacopoeia(USP).

27

28


28/45


28

29


29/45


The following information must appear on the PDP of aHomoeopathic Drug Product:

Statement of identity: The PDP must contain a statement ofidentity in bold type. It must use the established name of the drugproduct and a statement of general pharmacological category(ies)(e.g. Ipecacuanha3X - Nasal decongestant) or the principal intendedactions corresponding to its monograph.

Declaration of Net Quantity of Contents: The label must bear adeclaration of the net quantity of contents expressed in the terms of

weight, measure, numerical count, or a combination or numericalcount and weight, measure, or size.

29

30


30/45


The Drug Facts Box must appear on the Information Panel with:

Active ingredients: established name of each activeingredient and the quantity of each active ingredient per dosageunit expressed in homoeopathic terms, e.g., lx, 2x.

Purpose: general pharmacological category(ies) or theprincipal intended action(s) of the drug.

Use: indication(s) for the specific drug product.

Warnings: for indications conforming to those in OTC drug

final regulations, are required as appropriate.Directions for Use: Each drug product must bear adequatedirections for use.

Inactive ingredients.

30

31


31/45

USDA Labeling RequirementsCertified Organic Products

Whether a health food product, herbal dietary supplementproduct, natural cosmetic product, or herbal drug product, theUnited States Department of Agriculture (USDA) is theregulatory agency responsible for certified organic agricultural

products and their labeling.

Products produced in a foreign country and exported forsale in the U.S. must be certified and labeled according to theUSDA National Organic Program (NOP) regulations.

In Peru, there is presently one Accredited Certifying Agent(ACA) for the USDA NOP: Bio Latina Certificadora:http://www.biolatina.com
http://www.biolatina.com/http://www.biolatina.com/


32/45

33


33/45

Labeling RequirementsEcological Certification

Information on the labeling ofNOP certified organic products isprovided in Spanish language atthe website of Bio LatinaCertificadora, an Accredited

Certifying Agent (ACA) for theUSDA NOP in Peru:http://www.biolatina.com

Bio Latina website has a Spanish

translation of the NOP todownload.

34
http://www.biolatina.com/http://www.biolatina.com/


34/45

Labeling RequirementsEcological Certification

In order for a finished product to bear the Demeter logo it must bemade with Certified Biodynamic ingredients and meet theInternational Demeter Standards for Processing.

The International Demeter Standards for Processing is availablein Spanish language at:

http://demeter.net/standards/st_processing_s.pdf

The standards for labeling of Demeter products is also availablein Spanish language at:

http://demeter.net/standards/st_labelling_s.pdf

35
http://demeter.net/standards/st_processing_s.pdfhttp://demeter.net/standards/st_labelling_s.pdfhttp://demeter.net/standards/st_labelling_s.pdfhttp://demeter.net/standards/st_labelling_s.pdfhttp://demeter.net/standards/st_labelling_s.pdfhttp://demeter.net/standards/st_labelling_s.pdfhttp://demeter.net/standards/st_labelling_s.pdfhttp://demeter.net/standards/st_labelling_s.pdfhttp://demeter.net/standards/st_labelling_s.pdfhttp://demeter.net/standards/st_processing_s.pdfhttp://demeter.net/standards/st_processing_s.pdfhttp://demeter.net/standards/st_processing_s.pdfhttp://demeter.net/standards/st_processing_s.pdfhttp://demeter.net/standards/st_processing_s.pdfhttp://demeter.net/standards/st_processing_s.pdfhttp://demeter.net/standards/st_processing_s.pdf


35/45

Labeling RequirementsReligious Certification

The Islamic Food and Nutrition Council of America (IFANCA)signed a Memorandum of Understanding (MoU) with Halal Peru toprovide halal certification services to South American companies.

Halal Peru was born out of a need to provide Latin Americancompanies viable access to global markets, where halal is anecessary regulatory and compliance issue for food, beverage,pharmaceutical and cosmetic goods. Halal Peru will work withIFANCAs halal certification experts to provide halal certificationservices for companies interested in competing in global marketswhere consumers are looking for products with religiouscertification.

36


36/45

Labeling RequirementsReligious Certification

Kosher certified products are among the fastest growingcurrent trends in food processing. The U.S. is an epicenter for

kosher foods because it is home to 40% of the world's Jewishpopulation. The U.S. kosher market was estimated at US$12.5billion in 2008 and is predicted that this value will increase toUS$13 billion by 2013.

Spanish language kosher certification and labelinginformation is available from Kosher Peru:http://www.kosher.pe/certificacion-kosher.html

37
http://www.kosher.pe/certificacion-kosher.htmlhttp://www.kosher.pe/certificacion-kosher.html


37/45

Labeling RequirementsSocial Certification

The market for natural ingredients and finished natural productsthat bear some type of social certification continues to grow in theU.S.. More and more major brands are making commitments tousing certified ingredients in their products. Most of the SocialCertification Standards also include Ecological Sustainability

components. The most visible certification schemes so far in theU.S. market include:

38


38/45


There are already a significant number of Peruvian producersand traders exporting products that are Fair Trade Certifiedthrough the Fair Trade International (FLO) system includingbananas, cane sugar, cocoa, coffee, fresh fruits (coconuts,lemons, mangos, oranges, papayas, passion fruit, pineapples),

fruit juices, gold, nuts and oilseeds (Brazil nuts), and seed cotton.

Although the labeling and logo use requirements through FairTrade USA will soon change due to its recent resignation fromFLO, the current Fair Trade Certified Label and Language UseGuide is available at:

http://transfairusa.org/sites/default/files/uploads/Label%20Use%20Guide.pdf
http://transfairusa.org/sites/default/files/uploads/Label%20Use%20Guide.pdfhttp://transfairusa.org/sites/default/files/uploads/Label%20Use%20Guide.pdf


39/45

40


40/45


The FairWild Standard assesses the harvest and trade of wildplants against various ecological, social and economicrequirements. Use of the FairWild Standard helps support effortsto ensure plants are managed, harvested and traded in a way thatmaintains populations in the wild and benefits rural producers.

The FairWild Certified seal tells buyers that they are supportingfair trading of legally and sustainably sourced wild products.

The FairWild Standard is available in many languages includingArmenian, Azeri, Bosnian, Chinese, English, French, Georgian,German, Japanese, Polish, Portuguese, Russian, and Spanish.

http://www.fairwild.org/documents

41
http://www.fairwild.org/documentshttp://www.fairwild.org/documents


41/45


42


42/45


"Fair for life" is a third party certification programme for socialaccountability and fair trade in agricultural, manufacturing andtrading operations. The Fair for Life Social & FairTradeCertification Programme combines strict social and fair tradestandards with adaptability to local conditions.

The "fair for life - Social & FairTrade certified by IMO"certification seal guarantees that the production complies at allstages with the social responsibility as well as fairtrade criteria ofthe Fair for Life Social & FairTrade Certification Programme.

43


43/45


The Fair for Life Social & FairTrade Programme Standard isavailable to download at:

http://www.fairforlife.net/logicio/pmws/indexDOM.php?client_id=fairforlife&page_id=download&lang_iso639=en

The labeling and control criteria for products labeled as Fair ForLife Fairtrade Certified is available at:

http://www.fairforlife.net/logicio/client/fairforlife/file/FFL_2011__1_Labelling_and_Control.pdf

For Processors, Packers and Wholesalers a specific labeling

guide is available at:http://www.fairforlife.net/logicio/client/fairforlife/file/Labelling_Guide_Fairforlife_Handlers_2010-001.pdf

44
http://www.fairforlife.net/logicio/pmws/indexDOM.php?client_id=fairforlife&page_id=download&lang_iso639=enhttp://www.fairforlife.net/logicio/client/fairforlife/file/FFL_2011__1_Labelling_and_Control.pdfhttp://www.fairforlife.net/logicio/client/fairforlife/file/Labelling_Guide_Fairforlife_Handlers_2010-001.pdfhttp://www.fairforlife.net/logicio/client/fairforlife/file/Labelling_Guide_Fairforlife_Handlers_2010-001.pdfhttp://www.fairforlife.net/logicio/client/fairforlife/file/Labelling_Guide_Fairforlife_Handlers_2010-001.pdfhttp://www.fairforlife.net/logicio/client/fairforlife/file/Labelling_Guide_Fairforlife_Handlers_2010-001.pdfhttp://www.fairforlife.net/logicio/client/fairforlife/file/FFL_2011__1_Labelling_and_Control.pdfhttp://www.fairforlife.net/logicio/pmws/indexDOM.php?client_id=fairforlife&page_id=download&lang_iso639=en


44/45

Fair for LifeCertified Fair Trade Bar Soap


45/45

QUESTIONS?

us product labeling guide (josef brinckman)

Documents