TINA’s Take: How the Feds Should Be Smarter about Brain Claims

WHAT’S UP

As baby boomers age, memory supplements are a growing market, with sales doubling in value between 2006-2015– a larger increase than for dietary supplements as a whole. Older adults are especially vulnerable to marketing claims about memory products that promise to prevent or reverse declines in cognitive function, according to the FBI.

With about 500 memory supplement products on the market and sales estimated at more than $600 million, the Government Accountability Office (GAO), at the behest of the Senate’s Special Committee on Aging, took a look at how the government regulates the market and found some troubling issues.

HOW WE GOT HERE

The FDA and FTC share oversight of supplements and are limited in their authority. Neither agency has premarket authority that allows for review or approvals of labeling or advertising claims before supplements may be sold to consumers. In general, the FTC has jurisdiction over advertising claims, and the FDA is responsible for the safety and nutritional labeling. But supplements do not get the same level of scrutiny as drugs. While supplements may not make health claims that the FDA hasn’t approved, under the Dietary Supplement Health and Education Act of 1994 (DSHEA), supplements do not have to be approved for safety or effectiveness before they are sold to consumers.

With 50,000-90,000 supplements on the market, a low barrier to entry, and an ease in which firms can start a website to sell products, the FDA reported to GAO that its “ability to access reliable and current information on the dietary supplement market is a challenge.”

THE MARKETING PITCH IN QUESTION

And problematic claims are out there. The GAO report, which reviewed memory supplements advertised on the internet, television, and in retail stores, magazines and newspapers during a two-month period, found 28 examples of memory supplements making potential disease-related treatment claims associated with 34 products  — 27 of which the FDA determined violated federal requirements.  The ads claimed the products protect against, reduce the risk of, and/or assist with symptoms of dementia, Parkinson’s or Alzheimer’s disease

Some of the problematic claims include:

Invest in yourself, protect & secure your future. Order anti-Alzheimer’s herbs.

 

Improves Cognition and Behavioural (sic) Symptoms in Alzheimer’s patients

 

Consider it preventive program for cancer, Alzheimer’s Diseases and more

 

Studies indicate this supplement may help protect against age-related memory decline, including Parkinson’s disease.

 

Provides homeopathic aid in support of assistance with the symptoms of dementia

 

We have compiled a list of the vitamins which have the most evidence for reducing the risk of developing Alzheimer’s or dementia as well as slowing their progress.

 

WHAT’S NEXT

The FDA has issued advisory letters to only two firms about the problematic product claims the GAO found in its report that was published in May. FDA officials told GAO that it is not currently focused on prioritizing the use of supplements by older adults. The FTC said that it does not prioritize enforcement efforts by category, though it does focus on marketing directed at vulnerable populations including older consumers.

The FTC took no action involving memory supplements in 2016, but in 2017 it charged the marketers of Prevagen, a company that was the center of a TINA.org investigation and complaint to the agency, with making false and unsubstantiated claims that the product improves memory, provides cognitive benefits, and is “clinically shown” to work.

In its conclusion, the GAO report recommended that the two agencies clarify their oversight roles, noting that consumers may be confused about which agency to notify regarding memory supplement issues. The report warned:

Absent clarification of FDA and FTC roles, consumers may not understand which agency to report concerns to involving internet marketing and there is a risk that agencies may not receive consumer complaints directly, which may delay agencies from taking action to address a problem.

Still, with all those memory supplements on the market and a small percentage of regulatory actions, consumers need to be on guard against claims relating to mental function. Remember readers, marketing supplements as having the ability to treat, cure, alleviate the symptoms of, or prevent developing diseases and disorders is not permitted by law. If a product really could do all that, then it would be a drug subject to rigorous study and testing to gain FDA approval.