The FDA has taken action against 17 companies claiming their supplements can treat or prevent Alzheimer’s disease.
The U.S. Food and Drug Administration (FDA) does not regulate dietary supplements in the same way as conventional drugs. Companies that manufacture and distribute supplements are not allowed to mislabel their products, but the companies themselves are responsible for evaluating product safety and efficacy. The FDA steps in only when a product has been reported as mislabeled, misbranded, or dangerous.
Such was the case when the FDA posted 12 warning letters and five online advisory letters to companies illegally selling products that claim to prevent or cure Alzheimer’s disease and other serious conditions including diabetes and cancer. These products have not been evaluated by the FDA and, according to PR Newswire, “These products may be ineffective, unsafe and could prevent a person from seeking an appropriate diagnosis and treatment.”
In a statement, FDA commissioner Scott Gottlieb says that while dietary supplements can provide health benefits when their claims are substantiated, unsubstantiated claims can discourage patients from seeking effective, FDA-approved medical products.
In addition to sending the warning letters, the FDA has announced a new strategy to crackdown on supplements making misleading health claims. They’ve recently taken action against companies pushing products that claim to fight cancer and opioid addition. In 2018, the agency also took action against male enhancement products containing sildenafil and/or tadalafil, which are some of the active ingredients in the FDA-approved products Viagra and Cialis, as well as against products that contain high concentrations of caffeine.
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The supplement industry has grown significantly since Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994. The act changed the way dietary supplements were regulated and puts the burden of proof for showing a product is dangerous on the federal government. Since the act was passed, the supplement industry has gone from a $4 billion industry to an over $40 billion industry.
Three-quarters of American consumers take supplements, and that percentage grows among older adults.
In response to the industry’s boom, and in response to the threat of misleading claims, the FDA has announced a new plan to modernize dietary supplement regulation.
The agency’s new plan includes steps to:
- Communicate concern about a product to the public as quickly as possible
- Work closely with industry partners
- Develop new enforcement strategies
- Continue to engage in public dialogue with dietary supplement stakeholders
“I’m concerned that changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks. To continue to fulfill our public health obligations we need to modernize and strengthen our overall approach to these products,” the FDA commissioner says.
While the FDA works to combat misleading health claims and promote transparency, consumers are advised to be extra wary of too-good-to-be-true claims.
Those concerned about Alzheimer’s, dementia, or other diseases are advised to talk to their doctor about the best prevention methods and disclose any supplements they’re currently taking.
Consumers can also visit the FDA’s website to get the latest information about drug safety. The Alzheimer’s Association also provides updated information about supplements claiming to have benefits for Alzheimer’s and dementia patients.Whizzco