Labels from a Regulatory PerspectiveLabels from a Regulatory Perspective
Labeling violations related to ingredient statements, allergen disclosure, statement of identity and nutrition facts are increasingly being cited in FDA warning letters, making it more crucial than ever for companies to review product labels for regulatory compliance.
April 12, 2012
The importance of proper labeling cannot be overstated. From a marketing and advertising standpoint, the label is often the first look that a consumer gets of a product. It is also the first chance for a company to promote a product and make a good first impression on potential customers. Of equal, if not greater, importance is the first impression labels provide to agents from FDA or other regulatory agencies. Improperly labeled products may cause regulatory personnel to question a companys knowledge of the applicable laws and regulations, and may lead to inspection of other products and labels, manufacturing practices and other aspects of a companys business that may have been avoided by simply labeling a product correctly. Based on FDAs actions through the first eight months of 2011, it is clear the agency is not confining its scrutiny of labels to just reviewing labels for disease claims; the technical aspects of food, beverage and supplement labels are being reviewed as well and identified when they are wrong.
It has been widely noted inspection frequency is rising dramatically as a result of the Food Safety Modernization Act (FSMA) and continued emphasis on overall food safety. As a result, compliance with cGMPs (current good manufacturing practices) has been a primary focus of many FDA warning letters in 2011. However, many of those warning letters and others identify labeling violations as well. While it is unlikely FDA is going to take regulatory action solely because the type size on a particular portion of a label is one size too small or because a particular nutrient was not indented properly on the Supplement Facts panel, compliance with labeling regulations is still crucial to the overall health and well-being of a company. If FDA reviews a product label and determines it was not labeled correctly, the agency might very well conclude other aspects of the company and its products should be looked at more closely to see whether the company is non-compliant in other areas. The relatively minor labeling violation effectively becomes the gateway" to greater scrutiny on a company-wide level. Thus, it is vital for companies to ensure their product labels have undergone a careful review and are compliant with applicable labeling regulations. Following is an overview of some of the more frequent labeling issues cited by FDA in 2011:
The runaway winner for Labeling Violation Most Likely to Appear in a FDA Warning Letter" is the failure to properly identify ingredients. 21 CFR 101.4 provides that, for food and beverage products, all ingredients must be listed by their common or usual name in descending order of predominance by weight. For dietary supplement products, all dietary ingredients must be listed in the Supplement Facts panel, and ingredients that are not dietary ingredients must be listed below the Supplement Facts panel with the heading Other Ingredients."
In 2011 warning letters, FDA identified a number of ingredients composed of sub-component ingredients that were not properly identified on the label. Examples include mustard, mayonnaise, yogurt and Swiss cheese, to name just a few. 21 CFR 101.4(b)(2) mandates ingredients such as those identified above that are comprised of two or more ingredients be identified in one of two ways. One option is for the ingredient to be listed in its proper place in the order of predominance with a parenthetical listing of all of the sub-component ingredients in descending order of predominance following the ingredient. The other option is to list each of the sub-component ingredients separately in the list of ingredients without listing the ingredient itself. Based on the number of warning letters containing allegations of failure to comply with this labeling provision, it is obvious such violations are at the top of FDAs labeling checklist.
Food Allergen Labeling
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) requires companies to disclose the presence of any of the eight major food allergens on the label of a food product if one or more of those food allergens is contained in the product. Those major allergens are milk, eggs, wheat, soy, peanuts, tree nuts, fish and Crustacean shellfish. In the case of the latter three, the specific type of tree nut, fish or Crustacean shellfish must be identified. If one of the eight major food allergens is identified by name in the list of ingredients, no further identification is necessary. However, if it is not clear from the ingredients, the label must disclose the food allergen. The food allergen may be identified in parentheses in the list of ingredients after the ingredient that is the source of the food allergen, such as whey (milk)," or the food allergen may be identified in a statement with the word Contains," followed by the food allergens, such as: Contains: milk, eggs."
The failure to properly disclose a food allergen on the label of a product has the potential for more severe consequences than most labeling violations. The failure to identify food allergens is viewed as a serious safety issue by FDA due to the potential harm to consumers who may experience allergic reactions to the particular food allergen. Companies are often faced with the need to recall mislabeled product, both to protect their customers and to avoid other action from FDA. In 2011, violations cited in warning letters for the failure to properly identify food allergens covered the spectrum of the eight major food allergens. One warning letter identified a particularly egregious violation wherein five major food allergens (crab, soy, egg, milk and wheat) were contained in one product, none of which were properly identified on the label. This is one labeling area in particular in which the failure to properly label a product can result in not only increased regulatory scrutiny, but big expenditures of time, money and effort as well.
Statement of Identity
The primary display panel (PDP) of a food in package form must bear a statement of the identity of the product, as set forth in 21 CFR 101.3. The statement of identity must be one of the following: 1) the name of the product as specified in or required by any applicable federal law or regulation; or, if there is no applicable law or regulation, 2) the common or usual name of the food; or, in the absence of a common or usual name, 3) an appropriately descriptive term or fanciful name commonly used by the public for such food. Pursuant to 21 CFR 101.3(g), dietary supplements must be identified with the statement of identity dietary supplement," except that the word dietary" may be replaced by the name of the dietary ingredients in the product, such as Iron Supplement." Every statement of identity must be on the PDP, in boldface type, in lines generally parallel to the base of the product, and must be in a size reasonably related to the most prominent material on the PDP.
Some companies received FDA warning letters for simply failing to provide any statement of identity, while others were cited for allegedly mischaracterizing the product. A May 2, 2011, warning letter to a Puerto Rican bottled water company alleged the statement of identity, Enhanced Fiber Water," was improper because the product was sweetened with sugar. Since water is specifically defined by regulation, and that definition does not include calories and sweeteners, FDA determined the statement of identify was improper. Another letter sent in May 2011 to a distribution company alleged the standard of identity Vegetarian Smoked Turkey Sandwich" was not an appropriately descriptive term because the product does not actually contain turkey. In an environment where FDA makes certain regulatory decisions based on the intended purpose of a product, the legally correct identification of a product could mean the difference between regulatory action or not.
Most food and beverage labels must display nutritional information in a Nutrition Facts panel pursuant to 21 CFR 101.9; the labels of dietary supplement products must display similar information in a Supplement Facts panel pursuant to 21 CFR 101.36. These regulations set forth detailed requirements for the types of nutrients, vitamins, minerals and other ingredients that must be identified and the proper format for providing such information. Both 21 CFR 101.9 and 21 CFR 101.36 also identify certain products that are exempt from providing nutritional information, such as products sold in bulk form or products with packaging that is too small to adequately contain such information.
FDA warning letters citing violations of 21 CFR 101.9 and 21 CFR 101.36 span a wide array of issues. The agency issued warning letters that identify labeling violations for the failure to identify serving sizes and the corresponding servings per container in a manner consistent with regulations. FDA also issued numerous warning letters for the failure to correctly identify certain nutrients, such as trans fat or dietary fiber. The agency has identified the failure to round off weights and measures as provided in the regulations. In several warning letters, FDA cited the omission of any nutritional information altogether as a violation. Nutritional information is viewed as a vital component of labels by FDA, and labels must comply with the requirements of these two regulations.
One labeling violation that has been cited more frequently this year is the existence of intervening material" on a label in violation of the provisions of 21 CFR 101.2(e). 21 CFR 101.2(e) requires all information on the information panel to appear in one place without intervening material. The required information includes the nutritional information, such as the Nutrition Facts panel or the Supplement Facts panel; the list of ingredients; the name and address of the manufacturer, packer or distributor; and any other information specifically required.
FDA has cited companies for providing intervening information such as 1) company slogans; 2) UPC codes; 3) country of origin" statements; 4) organic" certification statements; and 5) descriptive terms for ingredients, such as fresh." Curiously, FDA cited a company in one warning letter for providing intervening material because it included a food allergen statement immediately after the ingredient list. FDA stated in that warning letter that such a statement must be separated from the ingredient list so as not to give the appearance that it is part of the ingredient list. Yet the portion of the Federal Food, Drug and Cosmetic Act amended by FALCPA, 21 U.S.C. 343(w)(1)(A), mandates a food is misbranded if the food contains a major food allergen unless the word Contains," followed by the name of the food source from which the major food allergen is derived, is printed immediately after or adjacent to the list of ingredients.
Other Labeling Violations
Labeling regulations and violations arent confined to the issues discussed above. Labeling issues concerning the name and address of the manufacturer, and the net quantity of contents statement have also been cited with regularity by FDA. The proper labeling of claims, including nutrient content claims, health claims and natural" claims, always is of interest and concern to the agency. Whether it is a look by an FDA agent in a retail setting or in conjunction with an inspection, a review of product labeling by FDA is going to occur. Spending extra time now to review labels before a product is released on the market or viewed by FDA will save headaches, time and money down the road.
Justin J. Prochnow is a shareholder and regulatory lawyer in the Denver office of the international law firm of Greenberg Traurig LLP. His practice concentrates on legal issues affecting the food and beverage, dietary supplement and cosmetic industries. He can be reached at (303) 572-6562 or [email protected].
Hear Prochnow and David Barnes, Ph.D., director of research, Standard Process, impart expert analysis on dietary supplement claims challenges and what made them successful at the SupplySide MarketPlace education session, "Claims Substantiation and Compliance" on Wednesday, May 9, 9 a.m. to 11 a.m., Javits Center, New York.
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