Product Labeling Guide for Biodiversity Products in the United States Market

By: Josef Brinckmann, ITC Consultant Date: 26 September 2011

The Main Points.

What are the FDA labeling rules for health foods, herbal dietary supplements, 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 Cocoa Butter) and the differences in labeling requirements. USDA labeling rules for certified organic product labels. Importance of certifications for natural products to increase market chances: ecological (Biodynamic or Organic), religious (Halal or Kosher) and social (FairTrade or FairWild.

Why is this information important and who should study it?

U.S. labeling regulations are complicated and easy to get wrong. Our analysis shows that exporters from Latin America often have their products held up or refused entry for labeling violations. This labeling guidance will help exporters of finished natural products to better understand the labeling rules for different types of products in the U.S. market. ITCs U.S. Labeling Guide should be studied by your responsible person(s) for Legal and Regulatory Compliance as well as your firms managers of International Sales and Marketing.

Types of Labels
In the United States, finished natural products could fit into a number of different regulatory frameworks, depending on their composition, dosage form, and intended use(s), each with their own unique 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, and medical foods drug products: over-the-counter (OTC) conventional drugs including botanical drugs and herbal homoeopathic drugs, and prescription (Rx) drugs

Types of Labels

Voluntary Certification 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)

Labeling Requirements Non-drug Cosmetics

The following information must appear on the Principle Display Panel (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, a descriptive name, a fanciful name understood by the public, or an illustration representing the intended cosmetic use. The statement of identity must be shown in bold type and be in a size reasonably related to the most prominent printed matter on the PDP. An accurate statement of the net quantity of contents, in terms of weight, measure, numerical count or a combination of numerical count and weight or measure.

Labeling Requirements Non-drug Cosmetics

The following information must appear on the Information Panel of a non-drug cosmetic product: Name and place of business. This may be the manufacturer, packer, or distributor. Distributor statement. If the name and address are not those of the manufacturer, the label must say "Manufactured for..." or "Distributed by... Material facts. Examples include adequate directions for safe use, if a product could be unsafe if used incorrectly. Other examples of material facts include risk statements (e.g. cautions, contraindications, known side effects, warnings).

Labeling Requirements Non-drug Cosmetics

The following information must appear on the Information Panel of a non-drug cosmetic product: Warning and Caution statements (when necessary) must appear on the Information Panel of the cosmetic label prominently and conspicuously as compared to other words, statements, designs, or devices and in bold type on contrasting background so that the ordinary person can easily read and understand it. The Ingredients of the product must appear on the Information Panel of the cosmetic label prominently and conspicuously in descending order of predominance

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Labeling Requirements Food Products

Each different type of food product has different labeling rules: Conventional foods: including healthy food products eligible for approved health claims or qualified health claims labeling; Dietary supplements: regulated as a subset of food regulation and 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 dietary management of a disease or condition with distinctive nutritional requirements.

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Labeling Requirements Conventional Food Products

The following information must appear on the PDP of a conventional food 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 of identity must be shown in bold type and be in a size reasonably related 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 numerical count and weight or measure. The statement must be in terms of fluid measure if the food is liquid, or in terms of weight if the food is solid, semisolid, or viscous, or a mixture of solid and liquid.

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Labeling Requirements Conventional Food Products

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 descending order of predominance by weight . Name and place of business of manufacturer, packer, or distributor. If the food product is not manufactured by the business or person whose name appears on the label, the name must be qualified by a phrase that reveals the connection between that company and the product; such as Manufactured for ___, Distributed by ___, or any other similar wording

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Labeling Requirements Conventional Food Products

This information must appear on the Information Panel of a food (unless all essential information already appears on the PDP). Country of origin statement must be conspicuous. If a U.S. firm's name and address is declared as the firm responsible for distributing the product, then the country of origin statement must appear in close proximity to the name and address and be at least comparable in size of lettering. Nutrition labeling. Required nutrition labeling information must appear on the Information Panel in the Nutrition Facts box format.

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Labeling Requirements Conventional Food Products

This information must appear on the Information Panel of a food (unless all essential information already appears on the PDP). Nutrient content claims (high in antioxidant vitamin C or good source of fiber) are permitted under certain conditions on labels of food products that meet the requirements. These statements must appear 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 facts include risk statements (e.g. cautions, contraindications, known side effects, warnings)

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Labeling Requirements Conventional Food Products

This information must appear on the Information Panel of a food (unless all essential information already appears on the PDP). Warning and Caution statements (when necessary for safe use) must appear on the Information Panel or PDP of the food label prominently and conspicuously. Allergy labeling (Contains statement). All packaged food products must comply with the food allergen labeling requirements of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). Under FALCPA, major food allergens must be listed on the Information Panel in a Contains statement. For example: Contains Brazil nuts.

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Example of Nutrition Facts Box Format Requirements

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What About Bilingual Labels?

Label text must be in English except in the Commonwealth of Puerto Rico where the labeling may be presented in Spanish language (or in bilingual labeling) or in other U.S. territories where the predominant language is one other than English. Bilingual labels are permitted in the U.S. market so long as all of the required elements are provided in both languages (e.g. in both English and Spanish). Chamorro language could be used on product labels in the American territory of Guam and in the U.S. Commonwealth of the Northern Mariana Islands. Hawaiian is an official language of the State of Hawaii and could be used in bilingual labeling with English.

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Example of Acceptable Bilingual Nutrition Facts Labeling

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Labeling Requirements Dietary Supplement Products

The following information must appear on the PDP of a DSP: The statement of identity is the common or usual name of the dietary supplement or an appropriately descriptive term. The term "dietary supplement" must be used as part of the statement of identity, except that the word "dietary" may be replaced with the name of the dietary ingredient(s) (cats claw supplement) or an appropriately descriptive term indicating the type of dietary ingredient(s) (herbal supplement). The net quantity of contents statement must be located as a distinct 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.

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Permitted Structure/Function Statements Dietary Supplement Labeling

Dietary supplement labels may bear statements that describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, provided that such statements are 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 claim is an authorized health claim for which the product qualifies.

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Required Disclaimer Statement Dietary Supplement Labeling

Each structure / function claim statement appearing on a DSP label must be followed by an asterisk * which refers to the required Disclaimer Statement shown on the same panel of the product label: *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. The disclaimer must appear on every panel of the label where a claim is made. The disclaimer can be placed adjacent to the claim or set off in a box when it is not placed adjacent to the claim statement.

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Labeling Requirements Dietary Supplement Products

This information must appear on the Information Panel of a DSP: The Supplement Facts Box must appear as specified in the regulation 21CFR 101.36: Nutrition labeling of dietary supplements. Designation of ingredients: The common name of ingredients of dietary supplements that are botanicals (including fungi and algae) must be consistent with the names standardized in the American Herbal Products Associations Herbs 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 must be expressed in English (e.g., flower rather than flos).

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Labeling Requirements Dietary Supplement Products

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Labeling Requirements Dietary Supplement Products

The following information must appear on the Information Panel of a DSP (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 be shown. If the dietary supplement product is not manufactured by the business or person whose name appears on the label, the name must be qualified by a phrase that reveals the connection between that company and the product; such as Manufactured for ___, Distributed by ___, or any other similar wording.

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Labeling Requirements Dietary Supplement Products

This information must appear on the Information Panel of a DSP: Country of origin statement must be conspicuous. If a U.S. firm's name and address is declared as the firm responsible for distributing the product, then the country of origin statement must appear in close proximity to the name and address and be at least comparable in size of lettering. Material facts. An example is directions for safe use, if a product could be unsafe if used incorrectly. Other examples of material facts include risk statements (e.g. cautions, contraindications, known side effects, warnings).

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Labeling Requirements Dietary Supplement Products

This information must appear on the Information Panel of a DSP: Warning and Caution statements (when necessary for safe use) must appear on the Information Panel or PDP of the dietary supplement label prominently and conspicuously. Certain dietary supplements require specific statements defined in regulation. Allergy labeling (Contains statement). All dietary supplements must comply with the food allergen labeling requirements of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). Under FALCPA, major food allergens must be listed on the Information Panel in a Contains statement. For example: Contains Ginkgo Nuts.

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Labeling Requirements Herbal Homoeopathic Drug Products

Most U.S. Health Food and Natural Food Stores as well as Pharmacies 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 nearly the 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 the provisions of the Homoeopathic Pharmacopoeia of the United States (HPUS) and not to those of the United States Pharmacopoeia (USP).

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Labeling Requirements Herbal Homoeopathic Drug Products

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Labeling Requirements Herbal Homoeopathic Drug Products

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

Statement of identity: The PDP must contain a statement of identity in bold type. It must use the established name of the drug product and a statement of general pharmacological category(ies) (e.g. Ipecacuanha 3X - Nasal decongestant) or the principal intended actions corresponding to its monograph. Declaration of Net Quantity of Contents: The label must bear a declaration of the net quantity of contents expressed in the terms of weight, measure, numerical count, or a combination or numerical count and weight, measure, or size.

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Labeling Requirements Herbal Homoeopathic Drug Products

The Drug Facts Box must appear on the Information Panel with: Active ingredients: established name of each active ingredient and the quantity of each active ingredient per dosage unit expressed in homoeopathic terms, e.g., lx, 2x. Purpose: general pharmacological category(ies) or the principal 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 adequate directions for use. Inactive ingredients.

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USDA Labeling Requirements Certified Organic Products

Whether a health food product, herbal dietary supplement

product, natural cosmetic product, or herbal drug product, the United States Department of Agriculture (USDA) is the regulatory agency responsible for certified organic agricultural products and their labeling. Products produced in a foreign country and exported for sale in the U.S. must be certified and labeled according to the USDA 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

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Labeling Requirements Products with Certification Marks

In many cases, ingredient suppliers are marketing botanicals with multiple certifications (e.g. ecological, religious and social) in order to reach the broadest possible audiences. For example, here is a photographic advertisement of the Martin Bauer Group, one of the largest suppliers of botanical ingredients globally, showing an image of chamomile flowers (Matricaria recutita) with religious certification seals (halal and kosher) as well as fairtrade and organic seals

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Labeling Requirements Ecological Certification

Information on the labeling of NOP certified organic products is provided in Spanish language at the website of Bio Latina Certificadora, an Accredited Certifying Agent (ACA) for the USDA NOP in Peru: http://www.biolatina.com Bio Latina website has a Spanish translation of the NOP to download.

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Labeling Requirements Ecological Certification

In order for a finished product to bear the Demeter logo it must be made with Certified Biodynamic ingredients and meet the International Demeter Standards for Processing. The International Demeter Standards for Processing is available in Spanish language at: http://demeter.net/standards/st_processing_s.pdf The standards for labeling of Demeter products is also available in Spanish language at: http://demeter.net/standards/st_labelling_s.pdf

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Labeling Requirements Religious Certification

The Islamic Food and Nutrition Council of America (IFANCA) signed a Memorandum of Understanding (MoU) with Halal Peru to provide halal certification services to South American companies. Halal Peru was born out of a need to provide Latin American companies viable access to global markets, where halal is a necessary regulatory and compliance issue for food, beverage, pharmaceutical and cosmetic goods. Halal Peru will work with IFANCAs halal certification experts to provide halal certification services for companies interested in competing in global markets where consumers are looking for products with religious certification.

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Labeling Requirements Religious Certification

Kosher certified products are among the fastest growing current trends in food processing. The U.S. is an epicenter for kosher foods because it is home to 40% of the world's Jewish population. The U.S. kosher market was estimated at US$12.5 billion in 2008 and is predicted that this value will increase to US$13 billion by 2013. Spanish language kosher certification information is available from Kosher Peru: http://www.kosher.pe/certificacion-kosher.html and labeling

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Labeling Requirements Social Certification

The market for natural ingredients and finished natural products that bear some type of social certification continues to grow in the U.S.. More and more major brands are making commitments to using certified ingredients in their products. Most of the Social Certification Standards also include Ecological Sustainability components. The most visible certification schemes so far in the U.S. market include:

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Labeling Requirements Social Certification

There are already a significant number of Peruvian producers and traders exporting products that are Fair Trade Certified through the Fair Trade International (FLO) system including bananas, 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 Fair Trade USA will soon change due to its recent resignation from FLO, the current Fair Trade Certified Label and Language Use Guide is available at:
http://transfairusa.org/sites/default/files/uploads/Label%20Use%20Guide.pdf

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Labeling Requirements Social Certification

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Labeling Requirements Social Certification

The FairWild Standard assesses the harvest and trade of wild plants against various ecological, social and economic requirements. Use of the FairWild Standard helps support efforts to ensure plants are managed, harvested and traded in a way that maintains populations in the wild and benefits rural producers. The FairWild Certified seal tells buyers that they are supporting fair trading of legally and sustainably sourced wild products. The FairWild Standard is available in many languages including Armenian, Azeri, Bosnian, Chinese, English, French, Georgian, German, Japanese, Polish, Portuguese, Russian, and Spanish. http://www.fairwild.org/documents

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Labeling Requirements Social Certification

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Labeling Requirements Social Certification

"Fair for life" is a third party certification programme for social accountability and fair trade in agricultural, manufacturing and trading operations. The Fair for Life Social & FairTrade Certification Programme combines strict social and fair trade standards with adaptability to local conditions. The "fair for life - Social & FairTrade certified by IMO" certification seal guarantees that the production complies at all stages with the social responsibility as well as fairtrade criteria of the Fair for Life Social & FairTrade Certification Programme.

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Labeling Requirements Social Certification

The Fair for Life Social & FairTrade Programme Standard is available 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 For Life 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

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Fair for Life Certified Fair Trade Bar Soap

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