SupplySide

The Wide World of Food Regulations

August 1, 2003 Ivan J. Wasserman and Elisa A. Nemiroff Comments

Posted in Articles

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 regulations

In 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.

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