Dr Scott GottliebScott Gottlieb, MD
The FDA issued 12 warning letters and 5 online advisory letters to a number of companies, foreign and domestic, that are almost 60 unapproved products claiming to prevent, treat, or cure Alzheimer disease, among a number of health conditions.1

The majority of the products were being sold as dietary supplements on websites and social media platforms, without being reviewed by the agency for safety and efficacy. The FDA noted that these products may be ineffective, unsafe, and could ultimately prevent people from seeking the appropriate medical treatment.

“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,” FDA Commissioner Scott Gottlieb, MD, said in a statement.  “Alzheimer is a challenging disease that, unfortunately, has no cure. 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.”

“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,” he added.

Gottlieb noted that the actions levied by the agency today are part of a larger effort by the FDA to tackle the rapid growth of the dietary supplement industry by applying its regulatory initiatives to preserve the Dietary Supplement Health and Education Act (DSHEA). He said that DSHEA “sought to achieve the right balance between preserving consumers’ access to lawful supplements, promoting innovation in these products,” while maintaining the agency’s role as the public’s protector from unsafe and illegal commodities, as well as holding those who do not comply accountable.

“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.

Additionally, the FDA released a statement today outlining its plan to push forward policy to modernize the regulation of dietary supplements.2 According to the agency, 75% of American consumers take a dietary supplement on a regular basis‚ a rate that rises to 80% among older Americans.

These steps being taken by the FDA to streamline this regulation include public communication the moment a concern arises, ensuring that regulatory framework is flexible enough to both promote innovation and uphold safety, continuation of industry partner relationships, the development of new strategies to enforce regulations, and keeping public dialogue ongoing for feedback from dietary supplement stakeholders.

“The opportunity to strengthen the framework that governs dietary supplements couldn’t come at a more pivotal time,” Gottlieb said. “On the one hand, advances in science and the growth and development in the dietary supplement industry carries with it many new opportunities for consumers to improve their health. At the same time, the growth in the number of adulterated and misbranded products—including those spiked with drug ingredients not declared on their labels, misleading claims, and other risks—creates new potential dangers.”

The products cited in the warning and online advisory letters posted today included a variety of product types, such as tablets, capsules, and oils. The companies have been asked to respond to the FDA within 15 days of receipt of the letters with an explanation as to how they plan to correct the violations. “Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction,” the agency noted.

“Dietary supplements can, when substantiated, claim a number of potential benefits to consumer health, but they cannot claim to prevent, treat or cure diseases like Alzheimer,” Gottlieb noted. “Such claims can harm patients by discouraging them from seeking FDA-approved medical products that have been demonstrated to be safe and effective for these medical conditions.”

The companies issued warning letters, which were released February 5, 2019, included the following:
  • Pure Nootropics, LLC
  • TEK Naturals
  • John Gray’s Mars Venus LLC
  • Nutrition Coalition Inc
  • Blue Ridge Silver
  • Sovereign Laboratories, LLC
  • DK Vitamins
  • Peak Nootropics, LLC (also known as Advanced Nootropics)
  • Gold Crown Natural Products
  • Emmbros Overseas Lifestyle PVT LTD
  • Earth Turns, LLC
  • Capris Associates, Inc/BR Naturals
Those issued online advisory letters, which were distributed mostly in November 2018, included the following:
  • Alzheimer’s Corporation (ALZcorp)
  • Alzheimer’s Organization
  • Dr. Fitt Intelligent Designs, LLC
  • Healthcare Products, LLC d/b/a The Alzheimer’s Store d/b/a MindCare Store
  • This Wonderful Life New Age Shop

REFERENCES
1. FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer’s disease [press release]. Silver Spring, MD: FDA; Published February 11, 2019. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631064.htm. Accessed February 11, 2019.
2. Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight [press release]. Silver Spring, MD: FDA; Published February 11, 2019. fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631065.htm. Accessed February 11, 2019.