‘Illegally marketed’: CRN calls for FDA response to study on galantamine products
A research letter published in JAMA by Dr. Pieter Cohen, MD, from the Cambridge Health Alliance in Boston and scientists from Sciensano, a Belgian research institute, detailed results of a study comparing galantamine content and claims made by products marketed as generic drugs and "dietary supplements".
Dr. Cohen and his co-workers reported that the quantity of galantamine in products marketed as dietary supplements ranged from 2% to 110% of label claim.
In addition to the wide range of actual galantamine in the products marketed as dietary supplements, 30% of these products were found to be contaminated with Bacillus cereus sensu stricto–encoding enterotoxin genes, which have been linked to diarrheal illness.
“The laws regulating dietary supplements should be reformed such that the FDA has enforcement mechanisms to ensure that dietary supplement labels accurately reflect their contents,” concluded Cohen et al.
Galantamine is a plant alkaloid that has been approved by the FDA as a prescription medication for the treatment of mild to moderate Alzheimer dementia. Galantamine products marketed as dietary supplements make a variety of cognition-related claims, including memory enhancement.
The compound is not a legal dietary ingredient for use in dietary supplements, as pointed out in a statement by the Council for Responsible Nutrition (CRN).
'Illegally marketed'
"Products containing galantamine are not legitimate dietary supplements and, if offered as such, are illegally marketed,” said the association in the statement. “The Council for Responsible Nutrition urges FDA and any retailers who are selling these fake supplements to immediately remove them from the market to protect consumers."
When asked to comment on the new study and CRN’s statement, an FDA spokesperson told NutraIngredients-USA: “We appreciate studies like this for raising awareness and bringing needed attention to these matters. In general, the FDA does not comment on specific studies but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health. The FDA is reviewing the findings of the paper.”
It is not yet clear what action, if any, the Agency will take against these products and the companies marketing them, with such decisions said to be based on public health priorities and available resources.
In May 2022, the FDA did issue warning letters to multiple firms for selling adulterated dietary supplements, that contained, in some cases, new dietary ingredients (NDIs) for which the FDA had not received the required premarket NDI notifications.
Regarding galantamine, the Agency issued a Warning Letter over 20 years ago to a California-based company selling a product called “GalantaMind” that claimed to contain 8 mg of a “Galantamine hydrobromide extract”. In that warning letter, the FDA stated the product was not a legal dietary supplement because of the drug preclusion principle: Galantamine is authorized as a drug and therefore ineligible for use in dietary supplements.
Source: JAMA
Published online on Feb. 23, 2024. doi: 10.1001/jama.2024.0328:
“Accuracy of Labeling of Galantamine Generic Drugs and Dietary Supplements”
Authors: P.A. Cohen et al.
