FDA Provides a Healthy Extension to Comment on Healthy
In September 2016, the Food and Drug Administration (FDA) took a number of actions concerning the use of the term "Healthy" in the labeling of food products. The FDA published notice in the Federal Register on the use of the term, published a "Guidance for Industry: Use of the Term "Healthy" in the Labeling of Human Food Products and opened a docket in the Federal Register entitled "Use of the Term 'Healthy' in the Labeling of Human Food Products: Notice for the Request for Information (Request for Comments).
The FDA's Request for Comments Docket has attracted more than 725 comments and was to close on January 26, 2017, within a few days of the new administration taking office. At the request of industry groups and other stakeholders, on December 30, 2016, the FDA posted a Notice extending the comment period an additional 90 days until April 26, 2017.
The FDA's regulations currently define the term "healthy" and related terms (such as "health," "healthful," "healthfully," "healthfulness," "healthier," "healthiest," "healthily," and "healthiness") as implied nutrient content claims and establish criteria for bearing a "healthy" claim: (1) Specific criteria for nutrients to limit in the diet; and (2) requirements for nutrients to encourage in the diet.
The Guidance issued by the FDA in September 2016 provides that the FDA intends to exercise enforcement (i.e. not enforce) against manufacturers that use the term "healthy" on foods with a fat profile of predominantly mono and polyunsaturated fats, but which do not meet the regulatory definition of "low fat," or that contain potassium or vitamin D in at least 10 percent of the Daily Value per reference amount customarily consumed.
The FDA's Request for Comments was prompted by a number of factors, including a Citizen's Petition and requests from a number of academic and industry stakeholders. In its Request for Comments, the FDA states that it is "particularly interested in responses to the following questions:"
- Is the term "healthy" most appropriately categorized as a claim based only on nutrient content? If not, what other criteria would be appropriate to consider in defining the term "healthy" for use in food labeling?
- If criteria other than nutrient content are to be included in the definition of the term "healthy," how might we determine whether foods labeled "healthy" comply with such other criteria for bearing the claim?
- What types of food, if any, should be allowed to bear the term "healthy?" Should all food categories be subject to the same criteria?
- Is "healthy" the best term to characterize foods that should be encouraged to build healthy dietary practices or patterns? What other words or terms might be more appropriate?
- What nutrient criteria should be considered for the definition of the term "healthy?"
- If nutrients for which intake is encouraged are included in the definition, should these nutrients be restricted to those nutrients whose recommended intakes are not met by the general population, or should they include those nutrients that contribute to general overall health?
- Are there current dietary recommendations or nutrient intake requirements... that should be reflected in criteria for use of the term "healthy?"
- What are the public health benefits, if any, of defining the term "healthy" or other similar terms in food labeling?
- What is consumers' understanding of the meaning of the term "healthy" as it relates to food? What are consumers' expectations of foods that carry a "healthy" claim?
- Would this change in the term "healthy" cause a shift in consumer behavior in terms of dietary choices?
- How will the food industry and consumers regard a change in the definition of "healthy?"
- What would be the costs to industry of the change?
FDA-regulated industry has entered a new era where science, the Constitution, common sense, a receptive FDA and a new administration are aligning to usher in significant change to the regulation of product labeling. With the aid of science, the courts are refocusing on the limitations placed on government in 1791 with the ratification of the First Amendment to the Constitution, and with the aid of common sense, stakeholders are pursuing new approaches to labeling through other means, such as Citizen's Petitions. It remains to be seen whether the new administration and leadership at the Department of Health and Human Service will help effect positive change in the regulation of food labeling. However, one thing is certain; industry has been emboldened and the FDA appears to be responding.
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Mike devotes much of his practice to counseling clients in regulated industry on issues related to manufacturing, labeling, compliance and transportation. He has extensive experience defending clients in complex administrative law and litigation matters, and has served as national coordinating counsel, regional trial counsel and as local Texas counsel in environmental and toxic tort litigation. Mike has practiced in Dallas since 1994. Prior to 1994, he practiced in New York City as a trial lawyer handling a broad range of matters including securities, commercial, real estate, intellectual property, pharmaceutical, toxic tort and environmental contamination matters. He is the author of the law book, The Supply and Distribution of FDA Regulated Products published by Thompson Reuters. Mike is a frequent writer and speaker on issues related to compliance and litigation for regulated industry and is regularly published on issues concerning toxic exposure, compliance and marketing. Mike is the founder of a daylong educational program designed for lawyers and senior industry executives in industry regulated by the federal Food and Drug Administration.