The product is aimed at women planning to get pregnant, pregnant women (including those of high-risk) and post-partum women who have distinct nutritional requirements for specific nutrients.
The product is labeled as a ‘medical food’, but does not meet the statuary definition of this under the Federal Food Drug and Cosmetics Act (FD&C Act), said the FDA, as it is intended for the dietary management of a condition with nutrient requirements that cannot be met through modification of diet alone.
Therefore calling it a ‘medical food’ clearly violates the act.
The FDA ordered all product labeling to be revised in order to ensure compliance with the requirements of the Act and all applicable regulations.
In addition, the FDA noted that the label on the prenatal product appears to contain an NDC number, which is uniquely intended for the identification of drugs
The FDA ordered that the company respond in writing within 15 days of receiving the letter, detailing the changes being made to product labeling that will ensure its compliance with the requirements of the Act and all applicable regulations.
Failure to promptly correct violations may result in regulatory action being initiated without further notice, such as seizure and/or injunction, said the FDA.
The FDA defines a medical food as the following:
i. It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding tube;
ii. It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has 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;
iii. It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation;
iv. It is intended to be used under medical supervision; and
v. It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.