“Without a doubt it is a change,” Peter Arhangelsky, a lawyer in the firm Emord & Associates, told NutraIngredients-USA. “It’s reflective of FDA’s opinion that there is a category of metabolic disorders that can be treated with diet alone.”
First, to what FDA actually said in the draft guidance. One of the questions added to the Q&A portion of the guidance asks whether the agency considers diabetes (whether type 1 or type 2) to be an eligible condition for a medical food. The agency responded:
“No. Diet therapy is the mainstay of diabetes management. A regular diet can be modified to meet the needs of an individual affected by either type of DM (along with appropriate drug therapy if necessary). Under 21 CFR 101.9(j)(8)(ii), a medical food must be intended for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone. Therefore, FDA generally would not consider a product labeled and marketed for DM to meet the regulatory criteria for a medical food.”
Some level of confusion has swirled around the sector for years, Arhangelsky said. A number of websites seem to be marketing products under the aegis of a medical food without making any mention of the need for these products to be used under the supervision of a physician as stated in the Orphan Drug Act, where medical foods are defined. These marketers seem to be positioning their products as some sort of ‘super supplements’ without fulfilling the regulatory requirements of a medical food. Is this honest confusion? Or a cynical attempt to attach a kind of “doctor approved” patina to a product?
“For years you have seen FDA concerned that dietary supplements are pushing the envelope and what you are basically selling are medical foods that were dietary supplements in disguise,” Arhangelsky said.
“This is a reaction to that I think. But when I read this guidance I think that this can’t help patients in any way,” he said.
“Unfortunately you are always going to have people trying to claim a little bit more than what they are entitled to,” Arhangelsky said. “But there also is this enormous uncertainty with respect to how FDA is going to enforce things.”
Several companies are either manufacturing ingredients aimed at medical foods for diabetes, or have finished product medical foods on the market such as Abbott Labs and Metagenics. Companies active in this market that were contacted for comment are still formulating their official responses to FDA.
“They are drawing a line in the sand which, especially in regard to diabetes, might not be that easy. This is more of a physician question; what if a patient is trying to modify their diet and it’s not working?” said Ashish Talati, a partner in the law firm Amin Talati.
Challenge from industry foreseen
Talati said the draft status of the guidance means there is time for industry to have substantial input on the how the final guidance might come out.
“Right now this is just a draft guidance. Based on industry comments FDA may revise the final draft. I don’t think the status those products will change right now,” Talati said. “I definitely see some companies challenging this interpretation by FDA.”
But Arhangelsky wasn’t quite as sanguine on the idea that the word “draft” in the title of the guidance will not preclude FDA from using the ideas therein as the basis for near-term enforcement actions.
“There is a tendency for FDA to enforce these issues even before they actually go final. We saw that with the draft NDI guidance,” he said.
Go here to read the full text of the draft guidance.