The Food and Drug Administration has just taken action against many companies that advertise their dietary supplements for dementia. The commercials often imply that these products could be used to treat Alzheimer’s disease. The FDA has sent warning letters advising these firms that their supplements are considered unapproved or misbranded drugs.
These products have not been approved by the agency and they have not been proven safe and effective. If the companies do not correct their violations within two weeks, the FDA has threatened to take legal action. The agency could seize the dietary supplements or charge fines. In the meantime, the FDA encourages consumers to remain vigilant so as to “avoid purchasing products that claim to prevent, treat or cure diseases without any proof they will work.”
Dietary Supplements for Dementia Are Not the Only Problems:
This crackdown is part of a larger initiative. FDA Commissioner Scott Gottlieb announced that the agency is planning to modernize its dietary supplement regulation. The agency has not changed its approach to dietary supplements for dementia or any other serious problem since 1994. That is when Congress passed the Dietary Supplement and Health Education Act, known as DSHEA. However, the business of dietary supplements has changed enormously in the past 25 years.
Commissioner Gottlieb pointed out that
“What was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 – and possibly as many as 80,000 or even more – different products available to consumers.”
The FDA says it wants to make sure that consumers continue to have access to safe supplements. Consequently, the agency plans to communicate more promptly and clearly about problems. In addition, the FDA wishes to evaluate product safety while still promoting innovation. It acknowledges that this will require new enforcement strategies and public dialogue. In this way, the agency hopes to protect the public from adulterated and misbranded products, starting with dietary supplements for dementia that have no known impact on cognitive function.