Medical Foods No “Dumping Ground” For Disease Claims – FDA

FDA’s Dan Fabricant warns placing a medical food label on a dietary supplement constrained by structure/function claims does not make disease claims for the product legal. He says the agency is cracking down on products mislabeled as medical foods and on medical foods making disease claims.

FDA could take enforcement actions against a growing number of firms that are re-categorizing dietary supplements as medical foods in an attempt to make disease claims for the products, the agency’s supplement office chief warns.

“Medical foods are not the dumping ground for products to make disease claims. That is something the agency is taking action on and will continue to take action,” said Daniel Fabricant, director of FDA’s Division of Dietary Supplement Programs, March 6 at the NEXT Innovation Summit in Anaheim, Calif.

He noted that in 2013 FDA issued nine warning letters to firms about inappropriately categorizing products as medical foods and making disease claims for the products, up from three in 2012 (Also see "Ingredient Safety Concerns Rise Among FDA Enforcement Priorities" - Pink Sheet, 23 Sep, 2013.).

Fabricant acknowledged not all firms categorize products as medical foods with ill intent. Rather, he explained some firms misinterpret the statutory language for medical foods – that the products are for the specific dietary management of disease or a condition with distinct nutritional requirements – to mean a disease claim can be made for a product labeled as a medical food but not for the same product marketed as a dietary supplement.

However, disease claims are not allowed for medical foods or for dietary supplements, he said. “You cannot make disease claims for medical foods either. … There is no safe harbor on the food side to make disease claims.”

Daniel Fabricant, FDA Division of Dietary Supplement Programs director

Fabricant noted the brief description of medical foods in FDA’s regulations could give the appearance of having “a lot of latitude” for interpretation. But the definition is very narrowly limited to foods that must be used under medical supervision and not simply those recommended by a physician as part of an overall diet to manage symptoms or reduce disease risk.

Thus, the context in which disease states appear in the statutory definition of medical foods “is not to treat, cure or mitigate the disease. It is to manage something in the diet that [patients] cannot get in a normal diet,” Fabricant added.

The most recent medical food-related warning letter posted on FDA’s website, in December 2013, went to Accera Inc. about its Axona product being improperly marketed as a medical food indicated for Alzheimer’s disease. Because the condition has no distinct nutritional requirements, Accera could not claim that Axona meets the narrow regulatory definition of medical food (Also see "In Brief: FDA responds to Nasacort suit, acts on acetaminophen and continues medical food enforcement" - Pink Sheet, 20 Jan, 2014.).

Firms can gain more clarity about medical foods from draft guidance, including frequently asked questions published in August 2013 (Also see "In Brief: NAD on NourishLife, formula firms on selenium, medical food draft guidance" - Pink Sheet, 19 Aug, 2013.).

Jason Sapsin, counsel at Fox Rothschild LLP in Denver, noted at the conference that a historical lack of enforcement against products marketed as medical food compared to the dietary supplement space is one reason medical foods are a “very tempting category” to nutritional product firms that want to make disease claims.

Jason Sapsin, counsel at Fox Rothschild in Denver

Non-compliant firms tend to “go to those areas of regulatory and legal activity where resistance appears to be the lowest,” said Sapsin, a former associate chief counsel at FDA.

“As the agency increased enforcement efforts with respect to dietary supplements” and structure/function claims, firms began exploring medical foods as an area for making disease claims, he added.

Options For Making Disease Claims

Fabricant suggests firms that want to claim their products reduce the risk of disease seek FDA approval for a health claim. Certain health claims – either qualified or unqualified – and structure/function claims are allowed for dietary supplements.

“The agency is certainly interested in seeing more use of [the health claims process] with nutrients,” he said.

FDA currently has approved 84 health claims, including claims for calcium and vitamin D for osteoporosis and folic acid for neural tube defects, but industry stakeholders say the process for approval is tedious and the requirement to demonstrate significant scientific agreement for health claims is such a high bar that it may be insurmountable (Also see "Commentary: FDA Must Overcome Skepticism Toward Health Claims" - Pink Sheet, 22 Apr, 2013.).

Despite the challenges, the Global Organization for EPA and DHA Omega-3 petitioned FDA in November 2013 for unqualified health claims that EPA and DHA help lower blood pressure in the general population, reduce the risk of coronary artery disease and other similar claims (Also see "Omega-3 Petition Seeks Unqualified Blood Pressure, CHD Claims" - Pink Sheet, 3 Feb, 2014.).

An alternative to a health claim is to seek approval for qualified health claims, of which FDA has approved 14, Fabricant said. The standard for qualified health claims is not as high for unqualified health claims, but often the agency qualifies the claims so severely or awkwardly that many firms consider the claims unusable.