FDA Sends Medical Food Warning Letter

Two capsule products labeled as “medical food” but that FDA says do not meet the definition of medical food came under fire in the form of a warning letter in December. The letter, sent to NeuroScience Inc., says that the company’s Zymenta and Cerelist products do not meet the criteria for medical food as defined either by the Orphan Drug Act, 21 U.S.C. § 360 ee(b)(3), or 21 CFR 101.9(j)(8).

According to FDA’s letter, the NeuroScience products claim to aid in the “nutritional management of certain metabolic processes associated with dementias of mild-to-moderate Alzheimer’s disease or mild cognitive impairment.”

However, FDA said, medical foods are those solely designated for patients whose medical conditions impair them from properly ingesting, digesting, absorbing, or metabolizing foods to derive certain nutrients. In other words, a patient’s condition must prevent him or her from being able to obtain a nutrient from the normal diet alone. In addition, medical foods are intended for use under medical supervision.

“FDA considers the statutory definition of ‘medical food’ to narrowly constrain the types of products that fit within this category,” the agency wrote. “Medical foods are not those simply recommended by a physician as part of an overall diet to reduce the risk of a disease or condition.”

In the NeuroScience case, FDA challenged the company’s statement that patients with Alzheimer’s disease or mild cognitive impairment have ”nutritional deficits in cholinergic function.”

“While your labeling states that the patients for whom your products are intended have ‘nutritional deficits in cholinergic function,’ FDA is not aware of any evidence that patients with Alzheimer’s Disease (AD) or Mild Cognitive Impairment (MCI) have a limited or impaired capacity to ingest, digest, absorb, or metabolize choline, or other nutrients, or have a distinct requirement for choline or any other nutrient,” the letter states.

FDA also contended that while the company’s website implies that the diet alone may not supply an adequate amount of nutrients such as choline for the target patients, adequate amounts of choline can in fact be readily obtained in the food supply.

“Because your Cerelist and Zymenta products are intended to support conditions (AD and MCI) that do not have distinct requirements for certain nutrients, and also is intended to provide a level of nutrients that can be met through the modification of the normal diet alone, these products do not meet the regulatory criteria for medical foods set forth in 21 CFR 101.9(j)(8)(ii),” FDA concluded.

Nutritional Outlook thanks Marc Ullman for the tip.