Date: Feb 22, 2010
On February 22, 2010, the U.S. Food and Drug Administration (FDA) notified 17 food manufacturers that 22 of their product labels were in violation of the Federal Food, Drug and Cosmetic Act (FD&CAct). These Warning Letters were issued in response to FDA's recent efforts to encourage companies to review product labeling generally, and "front-of-pack" labeling in particular, in order to reduce the prevalence of false, misleading, or mischaracterized health claims. Such actions reflect FDA's goal of improving the reliability and accuracy of nutritional content information in light of unprecedented rates of obesity and diet-related disease in the United States, and precedes forthcoming Agency action expected to provide guidance for front-of-pack labeling in the near future.
FDA's warning letters address five general categories of claims deemed by the Agency to be false, misleading, or mischaracterized: Unauthorized Nutrition Content Claims, Drug Claims, Unsubstantiated Health Claims, Unsubstantiated Comparative Claims, and Allergy Claims. The warning letters encompass a comprehensive and diverse spectrum of food manufacturers, and include shortenings, juices, dressings, nuts, frozen foods, and desert products, among others. FDA references language appearing on both product labels as well as manufacturer websites as the basis for evaluation of product claims.
A. Unauthorized Nutrition Content Claims
FDA's evaluation of Unauthorized Nutrition Content Claims revealed violations in six subcategories of statements: Foods for Intended Infants, Trans Fats (unsaturated fat with trans-isomer fatty acid(s)), Monounsaturated Fats, Cholesterol, Antioxidants, and "Light" claims. Unauthorized Nutrition Content Claim violations were cited with respect to a majority -14 out of 17 - companies who received warning letters from FDA.
1. Foods Intended for Infants
Five companies were cited for violations of 21 C.F.R. §101.13(b)(3), in which the FDA noted that "except for statements that describe the percentage of a vitamin or mineral in relation to a [Recommended Daily Intake], no nutrient content claims can be made for a food intended specifically for use by infants and children less than 2 years of age unless specifically permitted by FDA regulations." Examples of claims cited for violation of the FD&CAct under this subcategory included sugar claims (e.g. low in sugar, no added sugar, no added refined sugar); fat claims (low in fat, no added fats or oils); vitamin and mineral claims (e.g. good source of Vitamin A, plus vitamins and minerals, excellent source of iron, calcium and zinc); and general health claims (e.g. healthy, as healthy as fresh).
FDA referenced explicit statements contained within product labeling as well as those displayed on the manufacturer's website to conclude that the product was intended specifically for use by infants and children younger than two years of age, including: for babies, designed specifically for young, developing taste buds, for infants and toddlers, as well as implicit statements evidenced by dual-column Daily Value (DV) percentages for infants and children, respectively.
2. Trans Fats
FDA notified four companies that their assertions of trans fat-free products failed to comply with the requirements of 21 C.F.R. 101.13(h). While assertions of "0g trans fat" or "no trans fat" are generally permissible under the FD&CAct, products containing nutrient content values of total fat, saturated fat, cholesterol, and/or sodium in excess of that outlined in the statute must include a disclosure statement on the label (immediately adjacent to the claim), directing the consumer toward nutrition information for those nutrients. For example, the statement "[s]ee nutrition information for [any required combination of:] fat, saturated fat, cholesterol and sodium content" is required for products which contain more than 13g of total fat, 4g of saturated fat, 60mg of cholesterol, and/or 480mg of sodium, respectively. Claims rejected under this provision included: 0g Trans Fat and 0 grams Trans Fat - Same Great Taste.
3. Monounsaturated Fats
Two companies were advised by FDA that their claims purporting to contain high levels of monounsaturated fats (which are believed to provide beneficial cardiovascular health benefits), were inappropriate under §101.62(c)(4) of the FD&CAct. Specifically, statements such as good source of monounsaturated fat and high in ‘good' monounsaturated fat were rejected by FDA, which commented that in order to make "good source" claims generally, a food must contain 10-19% of the recommended daily intake (RDI) or DV of the nutrient to which the term refers. The FD&CAct does not define levels of monounsaturated fat, and therefore such assertions constitute an unauthorized nutrient content claim.
FDA advised one company that their statements: cholesterol free and naturally cholesterol free were improper under the FD&CAct. Citing 21 C.F.R. §101.62(d)(1)(ii), FDA notes that in order to be "cholesterol free," a product must contain no more than 2g of saturated fatty acids per Reference Amount Customarily Consumed (RACC), among other requirements. The product in question exceeded this level of saturated fatty acids, and was declared misbranded by FDA.
Five companies were alerted that their claims pertaining to the presence of antioxidants in their products were in violation of the FD&CAct. Citing 21 C.F.R. §101.54(g), FDA noted that statements including: high antioxidant, full of nutritious antioxidants, fortified with antioxidants, abundantly found [antioxidants], rich in antioxidants, and powerful antioxidants appearing on product labels and company websites were improper absent elaboration as to which antioxidant the claim referenced.
FDA further notes that should such antioxidant(s) have been properly referenced, the antioxidant(s) referenced must have established RDIs, and must contain the requisite percentage of the nutrient as defined by the FD&CAct. Further, generic qualifiers such as full of, abundantly found, and rich, absent more, fail to independently demonstrate that they are synonyms for high, or good source, both otherwise approved as qualifiers under the FD&CAct.
6. "Light" Claims
FDA advised one company that their use of the term light resulted in the determination of their product as being misbranded under the FD&CAct. Citing claims appearing on both the product and the company's website, FDA noted that "pursuant to 21 C.F.R. §101.56(b)(1), a nutrient content claim using the term ‘light' or ‘lite' to describe a food that derives 50 percent or more of its calories from fat may only be used on the label of the food, without further qualification, if the fat content of the food is reduced by 50 percent or more per RACC compared to an appropriate reference food…"
However, note that foods that use the term "light" in the descriptive sense (physical or organoleptic attributes such as texture or color) are exempted from this requirement, provided that the term clearly conveys the nature of the product, and that the attribute referenced "appear[s] immediately proximate to the term ‘light' on the product's label."
B. Drug Claims
FDA advised five companies that assertions implying that their product demonstrated the ability to prevent, mitigate or treat a disease rendered their product a misbranded drug, and not a food, under the FD&CAct. Assertions varied significantly, but included claims relating to the prevention, mitigation or treatment of stroke, heart disease, cancer, arthritis, depression, erectile dysfunction, high blood pressure, Alzheimer's Disease, and Parkinson's Disease.
In each instance, such rendering also resulted in the drug becoming classified as a "new drug" under 21 U.S.C. §321(P) the Act, in that the "drug" was not generally recognized as safe and effective. New drugs may not be marketed in the United States in the absence of a New Drug Application (NDA), which requires FDA approval based upon evidence demonstrating that such drug is safe and effective.
Finally, FDA advised that because such product labels and company websites characterized their product as useful for the prevention, mitigation or treatment of diseases that are not amenable to self-diagnosis, "adequate directions for proper use could not be written so that a layperson could use these drugs safely for their intended purposes." In the absence of such adequate directions for use, the drug is misbranded under the FD&CAct.
C. Unsubstantiated Health Claims
Unsubstantiated health claims and assertions were rejected by the FDA with respect to four companies' products. Such statements were both explicit (e.g. the use of healthy in the product name; an assertion of low fat generally), as well as implicit (e.g. the use of a heart symbol adjacent to a statement pertaining to ingredients in the product). FDA condemned the use of such explicit and implicit qualifying statements where such statements failed to comply with relevant statutory provisions.
Further, FDA noted that an assertion with respect to an ingredient in food constitutes an assertion as to the (complete) product itself, and therefore impermissible ingredient claims render the product claim invalid as well. Many of the companies cited for making unsubstantiated health claims generally were also censured under the Nutrition Content and Drug Claims paragraphs appearing above.
D. Comparative Claims
One company was advised by FDA that their comparative claim failed to comply with the requirements of 21 C.F.R. §101.62(c)(4), which states that comparative claims must meet identify the reference food as well as provide quantitative data justifying the basis of the comparison. In the case of this violation, the company claimed that their product had less saturated fat than a generic class of competing product. However, the company failed to identify a specific competing product, and failed to demonstrate that their product contained 25% less saturated fat per RACC than the reference product.
E. Allergy Claims
FDA alerted one company that its product labeling included an advisory statement that the product contained an ingredient known to be an allergen to some consumers (using the qualifier "contains"). However, the ingredient list failed to disclose the presence of such ingredient in the product composition. FDA noted that the presence of this advisory statement where no such ingredient was included and could mislead consumers. FDA reminded the company that its labeling should comply with Good Manufacturing Practices.
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Companies that received warning letters were advised that their products were misbranded under the FD&CAct, and have been given 15 business days to respond to the Agency outlining their plans for taking corrective action with respect to product labeling violations.