Memory supplements lack ingredients touted for Alzheimer's patients, study finds

Some versions of a dietary supplement sold as a memory enhancer for Alzheimer's patients contained wildly inaccurate amounts of the drug, a new study shows.

Galantamine, a plant extract, is sold as a generic – approved by the Food and Drug Administration – that requires a prescription to treat mild to moderate Alzheimer's disease. It's also sold without a prescription as an over-the-counter supplement. Vendors market these products as aids for boosting memory or promoting lucid dreams.

The labels on the generic drugs and dietary supplements all say they include identical amounts of galantamine, however, a Harvard University-led study published on Friday in the Journal of the American Medical Association showed the products' contents vary widely.

Researchers concluded, based on product testing, that the generics were largely accurate, containing at least 97.5% of the ingredients listed on their labels. However, the dietary supplements' labels were far less accurate. In one case, a supplement contained just 2% of the ingredients in the quantities the label listed.

Furthermore, three of the 10 supplements, purchased from vendors on Amazon, contained a type of bacteria known to cause diarrhea, the study said.

Researchers said the study illustrates how differently the FDA regulates prescription drugs compared to over-the-counter supplements.

The FDA must approve applications from drug companies before they are allowed to market or sell a prescription drug. However, companies do not need FDA approval before they sell a dietary supplement. No regulator checks before a company markets a supplement, but the makers must present evidence that what they're selling is safe and the label on the product is accurate.

The researchers said their findings raise questions about the lack of oversight.

"There's no checks required prior to supplements going on store shelves," said Dr. Pieter Cohen, lead author of the study and an associate professor at Harvard Medical School. Cohen is also an internist at Cambridge Health Alliance.

In the case of galantamine, Cohen said, consumers should be wary about purchasing over-the-counter supplements. While these products purport to carry the same ingredients as prescription medicines, his team found "what's actually in the bottle is completely different."

'Lack of appropriate quality control'

Researchers purchased 10 versions of galantamine from over-the-counter retailers on Amazon. They also bought 11 generic versions of FDA-approved medication through a hospital pharmacy.

Both the generic drugs and supplements said on their labels they included 4, 8, or 12 milligrams of galantamine per tablet, pill, or serving. Researchers also evaluated a supplement that stated it contained 6 mg of galantamine.

All of the generic prescription drugs contained close to the amount of galantamine listed on the label. The generic with the least amount had 97.5% of the amount it said it had; the generic with the greatest quantity had 104.2%.

The amount of galantamine present in the supplements, however, ranged from 2% to 110% of the amount listed on the labels. Only one supplement tested had within 10% of the galantamine amount listed on its label.

In addition, three of the supplement brands the researchers tested were contaminated with the bacteria Bacillus cereus sensu stricto, which "may suggest lack of appropriate quality control during manufacturing," the study said.

There wasn't enough bacteria found in the supplements to make a person sick, Cohen said.

Sold as a 'memory optimizer' and for 'lucid dreams'

The study does not identify the names of the dietary supplement companies or the products evaluated for this study. The researchers said that's because the medical journal requested the names be removed before publication.

One product promotes itself as a "memory optimizer"; another says it "supports and maintains cognitive function."

Other products were sold to support "dream recall" or "lucid dream induction," a state in which a person is aware they are dreaming while asleep. "That's another marketing area for these," supplements, Cohen said.

The generic drugs were approved for patients with mild to moderate Alzheimer's disease, however, the drugs are not proven to prevent Alzheimer's or slow mild cognitive impairment.

Industry group: Galantamine supplements are 'illegally marketed'

The Council for Responsible Nutrition, a trade association for the dietary supplement and functional food industry, distanced itself from the galantamine products in a statement to USA TODAY.

"Products containing galantamine are not legitimate dietary supplements and, if offered as such, are illegally marketed," the statement said. "The Council for Responsible Nutrition urges the FDA and any retailers who are selling these fake supplements to immediately remove them from the market to protect consumers."

One problem in terms of controlling the output of supplements like these is that the FDA doesn't know what dietary supplements are sold, when new products are introduced, or what those products contain. The FDA this year proposed legislation that would require companies to list which dietary supplements they sell. The federal regulatory agency also has sought the authority to take more action against companies that produce noncompliant products.

Cohen, the study author, explained, "I see this as mainly a problem with the regulatory framework."

He said, "Congress has stipulated that the FDA has no role in vetting or checking the quality of dietary supplements before they land on the market."

FDA spokesperson Courtney Rhodes said the agency does not comment on specific studies, but confirmed officials would review the galantamine study. Rhodes added that such studies help the agency to "further our understanding about a particular issue and assist in our mission to protect public health."

Dr. Peter Lurie, president and executive director of the Center for Science in the Public Interest, said the study was a rare direct comparison of prescription drugs and dietary supplements.

"This is a massive black eye for the supplement industry," said Lurie, a former associate director at the FDA. "And it shows the quality of their products does not meet the kind of standard that any American would expect."

Ken Alltucker is on X, formerly Twitter, at @kalltucker, or can be emailed at alltuck@usatoday.com.

This article originally appeared on USA TODAY: Galantamine supplements lack amounts required for Alzheimer's