Two warning letters issued after Christmas and made public recently by FDA underscore the agency’s focus on the medical food category, said an expert in the field who advises companies on staying on the right side of the boundaries.
Justin Prochnow, a partner in the firm Greenberg Traurig, said the latest tide of warning letters on medical food started in mid August when FDA issued a draft guidance on the subject. On the same day it also sent a warning letter to Metagenics, one of the highest-profile players in the category, naming 14 products the company was selling at that time that the agency said did not meet the definition of a medical food. The most recent two letters, issued the day after Christmas, showed that after years of benign neglect FDA is zeroing in sharply on the category.
“In general FDA has not had a history of drilling down to make those distinctions and it definitely looks they they are going to continue to do so,” Prochnow told NutraIngredients-USA.
The two warning letters were addressed to a company called Accera and another to a company called NVN Therapeutics. In the Accera letter, FDA took the company to task for marketing a product as a medical food that would help with the “management of the metabolic processes associated with mild to moderate Alzheimer’s disease.” The warning letter cites further marketing language taken from company materials that states, “raised ketone body levels can enhance memory and cognition in some people with mild to moderate Alzheimer’s disease.”
No deficiency, no medical food
Trouble is, from FDA’s point of view, there are no scientifically agreed-upon nutritional deficiencies associated with Alzheimer’s. Addressing such a deficiency is what a medical food is supposed to be about, FDA says.
NVN Therapeutics was taken to task by the agency for marketing a product aimed at women with the purpose of “dietary management of Polycystic Ovarian Syndrome (PCOS) by reducing the incidence of metabolic syndrome and insulin resistance.” The product is based on the effect of its two active ingredients, chlorogenic acid and l-cysteine, on insulin resistance and hyperinsulinemia.
Product can have benefit and not be a medical food
Once again, FDA said, “there is no there are no distinctive nutritional requirements or unique nutrient needs for individuals with PCOS. In addition, although there are benefits to these patients obtaining Chlorogenic Acid and L-Cysteine in their diet, there are no established distinctive nutritional requirements or inherent needs for patients with PCOS to have these substances in their diets.”
So the key point to remember, Prochnow said, is that a medical food is not some sort of dietary supplement on steroids. Even if the active ingredients can have some benefit for certain consumers, as FDA admits in the NVN letter, the product must address a specific deficiency as well as meet certain other parameters to be called a medical food.
“In NVN’s case it looks as if they weren’t even making an attempt to address a nutrient deficiency,” Prochnow said.