A new paper by prominent industry critic Dr. Pieter Cohen, M.D., has found that some galantamine products marketed as supplements for memory and sold as drugs for Alzheimer’s care are understrength. 

The new research was published today in the journal JAMA Network. Cohen, who is associated with Harvard Medical School, had as collaborators several researchers associated with an institution in Belgium. 

The focus of the research is on the ingredient galantamine. This is a plant alkaloid with anticholinergic effects that has been approved by the FDA to treat mild to moderate Alzheimer’s disease. As a supplement, galantamine is marketed as a memory enhancer.  

It was first isolated in the 1950s by researchers in the former Soviet Union and Bulgaria. It has been researched for its ability to help Alzheimer’s sufferers whose disease is still in a mild state to better maintain some of their cognitive abilities. 

Approved for Alzheimer’s 

The drug was approved by the U.S. Food and Drug Administration in 2004 for this purpose. It’s important to note, however, that the drug is not approved for directly treating the disease. It neither cures Alzheimer’s nor slows the rate at which it destroys brain tissue. Rather, it helps manage some of the symptoms of the disease by helping to maintain acetylcholine levels in the junctions between those neurons that continue to function, but a relatively high percentage of patients don’t respond to the treatment. 

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When marketed as a supplement, the researchers said the products made a variety of claims including memory enhancement. 

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By the 1990s, a workable method for synthesizing the compound had been developed. A few of the supplement-like products mentioned in the Cohen paper claim to have been extracted from the root of red spider lilly (Lycoris radiata), although one just said "botanical extract." All the others claim galantamine hydrobromide on the label. Some of the products marketed as supplements contained additional ingredients as well, the researchers noted. 

OTC passes; supplements fail 

Cohen and his collaborators purchased 10 products marketed as dietary supplements in June 2023 on Amazon and 11 generic drug forms in September 2023 and had them all tested to determine how much of the active ingredient was in the bottles. 

For the supplements, the claimed dosages were 4, 6, 8, and 12 milligrams (mg). (The 12-mg dosages were supplied by two 6-mg pills). The dosages for the OTC forms were 4, 8, and 12 mg. 

Related:Alzheimer’s drug galantamine is not lawful in dietary supplements, FDA says

The testing revealed that all of the OTC drugs were within 10% of label claim in that they had between 97.5% and 104% of the stated dosage. 

The products marketed as supplements did not fare as well. Only one of these came close to meeting the label claim, having 109% of the stated dosage. The rest had from less than 2% up to 75% of the stated amount. In addition, three of the supplement-like products showed the presence of small quantities of bacteria, which would “suggest lack of appropriate quality control during manufacturing.” The researchers said the bacterial levels were low and unlikely to cause illness. 

The existence of understrength (or in some cases, essentially fraudulent) supplements poses a risk to the quality of life of Alzheimer’s patients, the researchers concluded. 

“Use of galantamine supplements instead of generic galantamine may adversely affect their care,” the paper noted. 

The paper concluded with a plea that has become a standard feature of Cohen’s papers for stronger enforcement mechanisms for the FDA. 

CRN: Galantamine not legit 

The Council for Responsible Nutrition was quick to note that as an FDA-approved drug, galantamine is not and never has been a legal supplement ingredient. 

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“Products containing galantamine are not legitimate dietary supplements and, if offered as such, are illegally marketed. 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,” the trade organization said in an emailed statement to Natural Products Insider.  

A number of products styled as supplements that list galantamine on the label are currently for sale on Amazon. It’s unclear whether these are the same as those that were tested, as the researchers chose not to name any of the products they purchased. Amazon did not immediately respond to a request for comment as to whether it would stop the sale of those products, as it has done in some other cases in which products contained questionable ingredients.