The Wide World of Food Regulations

August 2003

The Wide World of Food Regulations

By Ivan J. Wasserman and Elisa A. NemiroffContributing Editors

Importing or exporting improperly labeled food products can have costly consequences for manufacturers, as shipments can either be delayed or denied entry. Significant warehousing costs can accrue until labeling compliance is achieved. The quality and condition of perishable items can deteriorate to the point that they cannot be sold. In February 2003 alone, FDA denied entry of more than 400 shipments of food into the United States because they lacked the proper labeling.

Marketing food products globally requires careful attention to each country’s labeling laws. Companies will likely find that compliance with U.S. laws alone is insufficient, and they must ensure that they are aware of the various entities and laws that regulate product labeling. Certain labeling information — such as product name, ingredient listings and name of manufacturer or packager — may be common to many countries, but other required elements will vary by country, and each nation may have its own specific formatting and language requirements. This article provides a brief overview of the entities that regulate food-product labeling in the United States, Canada, Europe and Japan, as well as the main laws and regulations in each.

Stateside regulationsIn the United States, FDA is the primary regulatory body for food labels. Two exceptions do exist: USDA regulates foods such as meat, poultry and some egg products; and the Bureau of Alcohol, Tobacco and Firearms (ATF) regulates alcoholic beverages.

FDA’s authority is principally found in the Federal Food, Drug and Cosmetic Act (FDCA), which defines “food” as “articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article.” The Nutrition Labeling and Education Act of 1990 (NLEA), and the Dietary Supplement Health and Education Act of 1994 (DSHEA) amended the FDCA. The NLEA prescribed mandatory nutrition labeling for food products, while DSHEA imposed labeling requirements for dietary supplements and authorized the making of certain claims. Dietary supplements were formally recognized as a food within the meaning of the FDCA. The FDCA, together with its implementing regulations, sets forth specific food-labeling requirements.

The Fair Packaging and Labeling Act (FPLA) also provides specific product-labeling requirements that are similar in certain respects to the FDCA.

While individual state food-labeling laws generally follow the federal requirements, certain states may also have enacted their own requirements for specific products. A state may not want to wait for the federal government to act, and will look at ways to protect the health of the state’s citizens. For example, Texas has special warning requirements for dietary-supplement products containing ephedra. In California, Proposition 65 requires warnings on foods or any other products containing any of the chemicals noted on a list prepared by the state that are known to cause cancer or reproductive harm.

Food products sold in the United States must have a label written in English that bears the product name (the statement of identity); net quantity of contents; ingredients; name and address of manufacturer, packer or distributor; and “Nutrition Facts” panel. FDA regulations impose detailed requirements as to how these items must appear on the product label, including where they must appear, the format, the font size and the order of appearance.

Nutrient-content claims, those that characterize the level of a nutrient in a food, may appear on food-product labeling, provided that they meet the regulatory requirements. These include claims such as “free,” “low,” “high,” “good source,” “lean,” “reduced,” “less,” “light,” “more” and “extra,” as noted in Title 21 of the Code of Federal Regulations (CFR), sections 101.13 and 101.54 through 101.69. Also, health claims (a claim that links a substance and a disease, such as “calcium reduces the risk of osteoporosis”) must have FDA approval. This is found in 21 CFR, sections 101.14 and 101.70 through 101.81.

Dietary supplements have specific requirements: The label must include a “Supplement Facts” panel; it must identify the product as a “dietary supplement”; and it must list the name and quantity of each ingredient. Manufacturers may not label a dietary supplement as a conventional food or as the sole item of a diet.

The FDCA also sets forth parameters governing which claims may appear on dietary-supplement labels, which include, among other things, claims that either state that the product is intended to affect the “structure or function” of the human body (e.g. “support healthy joints”) or provide a benefit related to a classical nutrient deficiency disease (e.g. the role of vitamin D in preventing rickets). There must be adequate support to make this sort of claim and manufacturers must notify FDA that they intend to make a health-related claim. In addition, the following disclaimer must be included on the label: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Importantly, dietary-supplement labels may not bear any claims related to the treatment, cure or prevention of a disease. The line between a permissible “structure-function” claim and an impermissible “disease” claim is often difficult to define. FDA has provided its opinion on many of these claims, and manufacturers should take care to ensure any product-label claim is permissible under FDA guidelines.

Rules for a northern neighborIn Canada, two federal departments — Health Canada and the Canadian Food Inspection Agency (CFIA) — share responsibility for the development and enforcement of food-labeling requirements. These requirements are principally provided in the Food and Drugs Act, approved in 1985; and its implementing regulations, the Food and Drug Regulations (FDR). The Consumer Packaging and Labeling Act (CPLA), and its implementing regulations, the Consumer Packaging and Labeling Regulations (CPLR), list further labeling regulations.

Health Canada oversees health and safety standards and develops food-labeling policies regarding health and nutrition pursuant to the Food and Drugs Act. The CFIA administers food-labeling policies pursuant to the Food and Drugs Act and CPLA.

The Food and Drugs Act regulates food made, sold or packaged in Canada. The Act also covers food labeling, advertising and importation. The Act specifies the information that the product must have on its label, including the food’s common name, the manufacturer’s or producer’s name and address, and a list of ingredients. Complete labeling information must appear in English and French.

CPLA also governs the labeling of consumer food products and has overlapping requirements with the Food and Drugs Act. For example, they both require the product’s common name, and the manufacturer’s name and address on the label in both English and French. The CPLA also requires that the label declare the net quantity of the food product.

On January 1, 2003, Health Canada published amendments to the FDR, changing them in three ways. First, the amended regulations mandate that manufacturers must have a label on prepackaged foods listing calories and 13 specific nutrients — subject to certain exemptions — in a nutrition-facts panel. Second, the amendments update requirements regarding nutrient-content claims by establishing standardized reference and serving amounts to evaluate nutrient content, and they update the wording allowed for nutrient-content claims. Finally, the amendments permit claims that particular foods may reduce the risk of certain chronic diseases, such as heart disease, osteoporosis, high blood pressure and stroke. These regulations apply not only to product labeling, but also to advertising.

European understandingThe European Commission (EC) enacts “directives” designed to achieve harmonization between the laws of the European Union (EU) member states on particular issues. Individual member states must enact laws that embody the principles of these directives. Food labeling is enforced by the member state in which the food is sold. Therefore, while it is useful to understand the contents of EC directives for general food-labeling requirements in the EU, manufacturers should consult the specific laws in each member state where the food product is sold. For example, language requirements can vary by the country.

Council Directive 2000/13/EC is the presiding legislation on the labeling of food sold to consumers in the EU. The directive was enacted as a means of consolidating the many amendments to Council Directive 79/112/EEC, which established the basic rules for food labeling in the EU in December 1978.

Article 2 of Council Directive 2000/13/EC provides that labeling must not mislead a purchaser in any material way. The labeling must not mislead a purchaser with regard to any characteristic of the food, such as its nature, identity, properties, composition, quantity, durability, origin, or method of manufacture or production; by attributing any effect or property to the food which it does not possess; or by suggesting that the food possesses special characteristics when all similar foods possess such characteristics. In addition, the directive prohibits any claim that a food product is capable of preventing, treating or curing a human disease. Similar to laws enacted in the United States and Canada, the directive mandates that certain key information appear on food labels, including the name under which the product is sold; the list of ingredients; the quantity of certain ingredients or categories of ingredients; the net quantity (for prepackaged food products); the date of minimum durability (or best before date); and the name and address of the manufacturer or packager, or of a seller established in the EU.

The EC also has enacted specific laws regarding nutrition labeling. Council Directive 90/496/EEC prescribes nutrition-labeling parameters for foods sold to consumers. Unlike the United States, nutrition labeling is not required unless a “nutrition claim” is made on the label or advertising material — a representation that states or suggests that a food has particular nutrition properties due to the energy (calories) it provides and/or nutrients it contains. Only nutrition claims that relate to energy value, proteins, carbohydrates, fat, dietary fiber, sodium, vitamins and minerals are permissible.

Rising sun rulesIn Japan, the Ministry of Health, Labour and Welfare (MHLW) is responsible for overseeing the implementation and enforcement of food regulations. The Food Sanitation Law is the primary piece of food-related legislation in the country, and regulates the safety of food products, including their labeling. Japan has implemented other specific food-labeling laws, including the Law Concerning Prevention of Unfair Gift and Unfair Labeling, which prohibits false or exaggerated labeling; and the Nutrition Improvement Law, which establishes requirements regarding the labeling of products containing nutrients or energy.

Japan also has implemented a food-labeling law that specifically recognizes certain food products that are consumed “For A Specific Health Use” (FOSHU). Only foods approved for such a use may bear the title “FOSHU” on their label. FOSHU foods are similar to functional foods and consist of foods “similar in appearance to conventional foods, consumed as part of a usual diet, and demonstrated (to have) physiological benefits and/or reduce the risk of chronic disease beyond basic nutritional functions.”

To use the FOSHU label, the manufacturer’s product must contain MHLW preapproved foods or ingredients. The MHLW has established a list of such foods and ingredients that it deems backed by sufficient scientific evidence to support health claims. Marketers should consult this list before labeling a product as FOSHU. The FOSHU system also requires specific information to appear on products’ labeling, including, but not limited to, the approved health claim, the nutrition information, the list of ingredients and an indication that the food is FOSHU.

Understanding the food-labeling requirements of different nations, as well as the other laws and regulations applicable to food products — such as restrictions on ingredients, manufacturing and packaging requirements, and licensure requirements — can help manufacturers involved in the global economy avoid costly business disruptions. By taking a proactive stance and investigating these laws before they attempt to sell food products in foreign countries, companies can eliminate disruption concerns while offering products to a worldwide consumer base.

Ivan J. Wasserman is a partner in the Food and Drug Administration practice at Collier Shannon Scott, PLLC in Washington, D.C., and received his J.D. from The George Washington University Law School, Washington, D.C. He can be reached at [email protected]. Elisa A. Nemiroff is an associate in the advertising and marketing practice at Collier Shannon Scott, PLLC, and also received her J.D. from The George Washington University Law School. She may be reached at [email protected].

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