Dockets Management Branch
(HFA-305)
Food and Drug Administration
Room 1-23
12420 Parklawn Drive
Rockville, MD 20857
[Docket No. 97D-0086] Food Labeling: Draft Guidance on Diet Plans 62 Federal Register 18774.
Dear Sir or Madam:
The National Food Processors Association (NFPA) submits the following comments on the docket referenced above.
NFPA is the voice of the $430 billion food processing industry on scientific and public policy issues involving food safety, nutrition, technical and regulatory matters and consumer affairs. NFPA’s three laboratory centers, its scientists and professional staff represent food industry interests on government and regulatory affairs and provide research, technical services, education, communications and crisis management support for the association’s U.S. and international members, who produce processed and packaged foods, drinks and juices.
In general terms, NFPA supports the concept of FDA’s Draft Guidance on Diet Plans. NFPA believes strongly that claims about diet plans should follow the provisions of applicable laws and regulations. NFPA also agrees that properly constructed diet plans, in general, would be consistent with the objectives of the 1990 amendments to the Food, Drug and Cosmetic Act (FFDCA). NFPA commends FDA for its intention to be watchful of the types of claims expressed by marketers of diet plans, to ensure compliance with applicable laws and regulations. However, NFPA believes that FDA’s Draft Guidance on Diet Plans needs to be rewritten to be more comprehensive and prospective, and less confusing.
NFPA urges FDA to clarify further its guidance on diet plans in the area of health claims and nutrient content claims. In this important area, in particular, the guidance is confusing. For example, in its discussion of health claims at 62 FR 18774, FDA appears to suggest that a claim on a diet plan such as “low in fat and high in fruits and vegetables, to reduce your risk of cancer” would not be subject to regulation as a health claim. NFPA agrees that this type of statement does not constitute a health claim, but is a dietary guidance claim, subject to the requirements of sections 403(a) and 201(n) of the FFDCA. In contrast to a health claim, which associates a substance, such as a nutrient, to a disease or health related condition, this claim focuses on the benefits of a total dietary pattern in reducing disease risk. Thus, it does not meet the statutory definition of a health claim, even though it notes the disease risk reduction of a the diet. In accordance with the statutory definition of health claims in section 403(r)(1)(b) of the FFDCA, NFPA urges FDA to draw a clear distinction in this guidance document between dietary guidance claims which may focus on a total diet, and claims about specific foods and nutrients. NFPA urges FDA to express that claims on diet plans must only be truthful and not misleading, and that the specific regulations governing claims on foods are not applicable to diet plans.
NFPA does not believe that every food in a diet plan must meet the conditions of food label claims regulations in order for statements about the diet plan to be truthful and not misleading. FDA suggests in the section on nutrient content claims, at 62 FR 18775, that a claim that a diet plan provides low fat foods would necessitate all foods in the diet plan to be low in fat.
- “For example, a claim that a plan has been formulated to provide low fat foods, as compared to a claim that the plan has been formulated to provide a diet that is low in fat, would imply that the foods in the plan are low fat. Thus, every food in the plan would have to meet the definition for ‘low fat’ in 21 CFR §101.62(b)(2) to avoid being misbranded.”
NFPA believes that this statement is a prime example of confusing guidance. In the main clause, the guidance that plans “formulated to provide low fat foods … would imply that the foods in the plan are low fat” belabors the obvious. Few marketers of diet plans would claim the plan is “formulated to provide low fat foods.” The more likely claim would be that the diet plan itself is “formulated to be low in fat.” FDA offers no guidance on the matter of a claim characterizing the diet plan as low in fat, leaving the subordinate clause to stand unembellished.
NFPA urges FDA to state clearly that information about the nutritional attributes of a diet plan also are statements of dietary guidance, and therefore permissible insofar as they are truthful and not misleading. NFPA sees little distinction between a label statement “Choose a diet low in fat, saturated fat, and cholesterol,” one of the Dietary Guidelines for Americans, and a statement on the labeling of a diet plan such as “This diet is low in fat, saturated fat, and cholesterol.” The former statement would be permitted on a food label as dietary guidance, and the latter statement should be equally permissible on the label or labeling of diet plans. Again, NFPA urges FDA to draw clear distinctions in the guidance document between statements about diets and statements about foods.
NFPA believes that each food in the plan need not meet individually a claimed nutritional standard, such as “low fat,” provided that the diet plan is designed to assure that the total diet meets the standard claimed, such as “a low fat diet,”. Clearly, in a “low fat” diet plan, some higher fat foods might be included for variety and interest, and could be counterbalanced by some “fat free” foods, still rendering the total diet “low in fat.” To require each food to meet all the nutritional criteria the total diet is designed to meet (e.g., “low fat,” “low cholesterol,” “low saturated fat,” “adequate in all essential vitamins, minerals, and protein”) is unreasonably restrictive, and would sharply limit the ability of the food industry to design diet plans with sufficient variety and appeal to promote long-term compliance. On the other hand, where nutrient content claims or health claims are made for an individual food that is promoted a part of a diet plan, the food clearly should meet all applicable labeling requirements.
As a further enhancement to the FDA guidance document, NFPA urges the Agency to state clearly that individual foods provided as part of a diet plan would be expected to comply with the regulations applicable to foods in package form, including nutrition labeling and claims rules. This guidance would enhance distinctions drawn between foods and diets, and would clarify that all components of a diet plan need not conform to specific nutrient content claims or health claims in order for the total diet to reflect specific nutritional attributes or promote health benefits.
Unless the Agency’s policy views are expressed more clearly, FDA’s guidance document will do little to assist marketers of foods and diet plans in the development of nutrition and health benefit messages in labeling. NFPA requests that FDA clarify its meaning in the next iteration of the Draft Guidance on Diet Plans, to provide an unambiguous guideline to marketers of foods and diet plans.
NFPA also urges that FDA revise the Draft Guidance on Diet Plans to be more comprehensive and prospective in nature. NFPA notes that diet plans could include dietary supplements, yet FDA has not discussed claims for diet plans containing these products. As some permitted statements of nutritional support for dietary supplements could be confused with health claims, some Agency guidance on this issue, in the context of diet plans, would be welcome.
Similarly, it is conceivable that some diet plans could be marketed which consist of components that fall within the statutory definition of medical foods. Such diet plans of medical foods would have different regulatory requirements than foods for special dietary use or other food products marketed to the general population. NFPA understands that rulemaking for medical foods is being considered by FDA at the present time. Nevertheless, in the interim, NFPA urges FDA to address the issue of medical foods in the context of diet plans. In the same vein, diet plans composed of medical foods and diet plans consisting of foods for special dietary use should be distinguished clearly in the next iteration of this guidance document.
With respect to drug claims related to diet plans, NFPA disagrees that diet plans should be viewed as drugs. According to the statutory definition of “drug” at section 201(g) of the FFDCA, a “drug” must be an “article.” Diet plans themselves are not articles, but are fundamentally a set of concepts or ideas about appropriate eating. Applying well-established dietary principles to create a diet plan would not render that plan a drug. Such an interpretation misapplies the concept of “article” as used in the drug definition. NFPA notes that some diet plans may indeed include articles which are intended to be drugs, and such articles should comply with all relevant laws and regulations, in the same manner that foods in diet plans must comply with the requirements to which they are subject.
NFPA specifically takes issue with FDA’s statement at 62 FR 18775 that “a claim that a diet plan is a ‘therapeutic diet’ could subject the plan to the provisions of the act that apply to drugs and, in particular, to new drugs.” There are numerous diet plans that have been developed for the management of diagnosed chronic diseases — such as hypertension, hypercholesterolemia, renal failure, and diabetes — which clearly are not intended as drugs. Therapeutic claims about diet plans should be truthful and not misleading, as FDA emphasizes in the draft guidance document, in the paragraph on “False and Misleading Claims.” With proper clinical support, truthful claims that a diet plan can have a therapeutic effect in people are consistent with both scientific knowledge and public policy. NFPA suggests that FDA reemphasize the importance of rigorous substantiation of any claims made about the diet plan.
NFPA supports FDA’s general intent that diet plans, and all the foods included in the plans, must comply with applicable parts of the FFDCA and implementing regulations. Nevertheless, NFPA believes strongly that the Agency must draw clear distinctions in its guidance between statements about foods and statements about diets. Consequently, NFPA urges FDA to rewrite these draft guidelines to be clear and unambiguous.
Thank you for the opportunity to comment on this important issue.
Sincerely,
Regina Hildwine
Director, Technical Regulatory Affairs – FDA