FDA Should Adopt FTC` Regulatory Policy For Supplement Claims, CRN Says

FDA should emulate the Federal Trade Commission and focus on ensuring dietary supplements make truthful and substantiated label statements instead of worrying about what constitutes an implied disease claim, Council for Responsible Nutrition Scientific and Regulatory Affairs VP Annette Dickinson, PhD, commented at an FDA meeting on structure/function claims in Washington, D.C. Aug. 4.

Dickinson made her suggestion during a panel discussion addressing whether dietary supplements should be allowed to make implied disease claims, and if so, how to distinguish between an implied claim and a prohibited express claim.

The CRN exec maintained all claims not explicitly referring to a disease state are permissible structure/ function claims under the Dietary Supplement Health & Education Act. CRN voiced a similar position in comments it submitted to FDA in response to the agency's proposed redefinition of disease (¹ (Also see "FDA "disease" definition for supplements threatens structure/function claims -- CRN." - Pink Sheet, 17 Aug, 1998.)).

Following this premise, Dickinson said FDA should move past the issue of what constitutes an implied disease claim for dietary supplements and instead, "figure out what we can do to assure that everything that is said on the label is truthful, nonmisleading and substantiated, and get not quite so hung up on the definition of disease aspect."

Therefore, Dickinson argued, "the FTC model is excellent because it doesn't require you to make this decision about disease and non-disease." She noted FTC says "the amount of substantiation needed is related to the seriousness of the health claim...they don't really care whether you're making [the claim] for a drug, or you're making it for a supplement or you're making it for a food - you need the same amount of substantiation regardless of the product category."

Similarly, "it's right for [FDA] to look for more substantiation the more significant the health statement is [or] the more significant the health benefit is," Dickinson continued. At a February workshop CRN held on FTC's supplement advertising guidance, the commission noted it considers the severity of the condition being cited in claims (² (Also see "FTC Supplement Ad Guide Application "Negative" Grace Period Predicted" - Pink Sheet, 15 Feb, 1999.)). FTC released the guide last year (³ (Also see "FTC Use of Expert Opinions On Supplement Ad Claim Support Cited In Guide" - Pink Sheet, 23 Nov, 1998.)).

Dickinson did argue that egregious, blatantly improper supplement claims should be subject to FDA enforcement. She suggested that, after "getting rid of that stuff," the agency could then look at more controversial claims that fall into a "gray area."

National Nutritional Foods Association Executive Director Michael Ford agreed, also asking FDA to "look at the [FTC]" as a model. FTC has "no trouble at all identifying what we call the outliers - the egregious claim making products out there," Ford said. "It should not be difficult for the FDA to determine what disease means in this context," and thereby limit that "gray zone" of controversial implied claims.

New Mexico Attorney General's Office Director of Consumer Protection Robert Reyna said his office "can't permit a situation where it would be...held to be against the law to advertise a dietary supplement for a certain condition but you can put it on the label...and that's the upside-down situation that you're headed toward if you don't try to get conformity in the law between the types of implied claims that would be permitted in advertising and the types of implied claims that would permitted on the labeling of the products."

"The states enforce both the advertising and the labeling, and we would approach it from an evidentiary point of view," Reyna said. Referring to a supplement for joint pain, Reyna noted his office would take into account the ads supporting the product and the product's name as well as its labeling claims.

"We would [then] say 'Do these claims imply that this product is being sold for the purpose of treating arthritis,' or is it being sold only for...a limited claim that it has some affect on mobility or movement," he commented.

National Organization for Rare Disorders President Abbey Myers argued the issue of what constitutes an implied claim versus an express disease claim is a moot point, since "the public will interpret structure and function claims in exactly the same way that they interpret disease claims."

Myers takes the view that dietary supplements today are similar to unregulated medicines from the 19th century. She read the labels of some of those old products, including Payne's Celery Tonic, which says: "Restores strength and vitality to the blood, kidneys and bowels." Noting, "under your current proposed structure/function rules, Payne's Celery Tonic could be sold today as a modern nutritional supplement," Myers asked FDA for greater enforcement action.