Sale of Unapproved Products Prompt FDA Warnings, Advisories for 17 Companies

The FDA has posted12 warning lettersand 5online advisory lettersissued to companies that are illegally selling more than 58 products, including capsules, oils, and tablets, that claim to prevent, treat or cure Alzheimer disease and other serious conditions, agency officials said in a statement.

These products, which are often sold on social-media platforms and websites, have not been reviewed by the FDA and are not proven effective and safe to treat the diseases and health conditions that they claim to treat.

Many of the 58 products are sold asdietary supplements, which are unapproved misbranded and/or new drugs.

These products may be ineffective, unsafe, and could prevent a person from seeking an appropriate diagnosis and treatment, according to the FDA.

“Science and evidence are the cornerstone of the FDA’s review process and are imperative to demonstrating medical benefit, especially when a product is marketed to treat serious and complex diseases like [Alzheimer],” said FDA Commissioner Scott Gottlieb, MD.

"Any products making unproven drug claims could mislead consumers to believe that such therapies exist and keep them from accessing therapies that are known to help support the symptoms of the disease or worse, as some fraudulent treatments can cause serious or even fatal injuries," he said. "Simply put, health fraud scams prey on vulnerable populations, waste money and often delay proper medical care, and we will continue to take action to protect patients and caregivers from misleading, unproven products."

The companies targeted by the FDA’s online advisory and warning letters have been asked to respond to the agency within 15 days of receipt of the letters, stating how the violations outlined in the letters will be corrected.

Failure to correct the violations promptly may result in legal action, including injunction and/or product seizure, FDA officials said, in a statement.

As part of the FDA’s effort to protect consumers from Alzheimer disease health fraud, the agency has issued more than 40 warning letters in the past 5 years to companies illegally marketing more than 80 products making Alzheimer disease claims on social media and websites, and in stores. The FDA has also taken action in recent years against companies and dietary supplements making similar claims for the treatment of serious conditions, such as cancer and opioid use disorder.

Although these companies may have stopped making unproven claims or selling the products, numerous unsafe and unapproved products continue to be sold directly to consumers, due in part to the ease with which companies can move their marketing operations to new websites, according to the FDA.

The FDA’s online advisory and warning letters are part of the agency’s larger effort to address the growth of the dietary supplement industry, according to Gottlieb.

The FDA aims to preserve the balanced vision of the Dietary Supplement Health and Education Act (DSHEA), enacted by Congress 25 years ago, through the implementation of modern regulatory initiatives, Gottlieb said.

“That law sought to achieve the right balance between preserving consumers’ access to lawful supplements, promoting innovation in these products, while upholding our obligation to protect the public from unsafe and unlawful products and holding accountable those actors who are unable or unwilling to comply with the requirements of the law. Our newest policy efforts will seize the game-changing opportunity to further strengthen the regulatory framework overseeing dietary supplements and will hone in on important steps to both promote industry innovation while upholding the safety of these products as part of our overall commitment to protecting public health,” Gottlieb said.

Dr Gottlieb also outlined several new actions and policy priorities the agency will take in the coming months to improve the safety of dietary supplements and purported dietary supplements, including efforts to more rapidly communicate potential safety issues with dietary supplement products with the public, establishing a flexible regulatory framework that promotes innovation and upholds product safety and other, new steps the FDA could consider taking to better ensure product safety and integrity.

References

FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease [news release]. Silver Spring, MD; February 11, 2019: FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631064.htm. Accessed February 11, 2019.