April 2019

FDA clamps down on supplement claims for Alzheimer Disease

The FDA recently took action against 17 dietary supplement companies marketing products to prevent, treat, or cure Alzheimer disease (AD). A statement from FDA Commissioner Scott Gottlieb, MD suggests that this is just the beginning as the agency moves to strengthen overall dietary supplement regulation.

With the exception of certain supplements that are allowed by the FDA to make specific health claims, most dietary supplements cannot claim to treat, cure, or prevent a disease. Doing so makes them legally unapproved drugs. But many supplement companies bank on the ignorance of consumers and continue to skate this line. It can sway those with serious medical conditions away from using proven therapies. While no medications can cure AD, several prescription drugs are approved for treating memory loss and impaired thinking skills in people with AD. Unfortunately, they are only modestly effective at best, and all of the therapies that have been studied for AD in the past few years have failed in Phase III trials. This lack of progress regarding prescription drugs for AD makes many of these patients more susceptible to marketing ploys from supplement companies.

Despite understanding that no dietary supplements are proven to treat or prevent AD, many patients are likely to try them anyway. Tell patients that while some supplements such as ginkgo, phosphatidylserinevitamin Eacetyl-L-carnitine, and vinpocetine have shown some benefit for AD in clinical research, it's still too soon to recommend them. Also, remind patients that some supplements might worsen AD and should be avoided. For instance, there is some concern that St. John’s wort, a popular supplement for depression and anxiety, might worsen dementia in people with AD. Lastly, make sure patients know that some natural medicines, including even some with evidence of benefit in people with AD, might interact with medication for AD. For instance, there is concern that vitamin E might interact with memantine and reduce its effects in people with AD. There is also evidence that phosphatidylserine might increase acetylcholine levels. Since cholinesterase inhibitors also have this effect, there is concern that taking the two together might increase the risk of serious side effects such as slow heartbeat, muscle weakness, muscle pain, or breathing difficulties.

Patients should always consult their healthcare provider before starting a new supplement. To find out which other natural medicines might interact with medications for AD, check out our Interactions Checker.

The information in this brief report is intended for informational purposes only, and is meant to help users better understand health concerns. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions. Copyright © 2023 NatMed. Commercial distribution or reproduction prohibited. NatMed is the leading provider of high-quality, evidence-based, clinically-relevant information on natural medicine, dietary supplements, herbs, vitamins, minerals, functional foods, diets, complementary practices, CAM modalities, exercises and medical conditions. Monograph sections include interactions with herbs, drugs, foods and labs, contraindications, depletions, dosing, toxicology, adverse effects, pregnancy and lactation data, synonyms, safety and effectiveness.