GAO Reviews Dietary Supplement Claims as Aging Population Struggles With Memory Loss

Alzheimer’s disease is the most common form of dementia among older adults, with experts suggesting the ailment plagues more than 5 million Americans, according to the National Institutes of Health. As Baby Boomers survive past their 70s, 80s and beyond, old age brings with it a trifecta of complications: an increased risk of loss of memory, dementia and ultimately death.

Unsurprisingly, aging Americans—including those seeking to treat or prevent Alzheimer’s—are hungry to preserve their minds and fight off a loss of memories, and as the U.S. Government Accountability Office (GAO) acknowledged in a May 2017 report, consumers “have increasingly turned to dietary supplements for help."

That’s encouraging news for the dietary supplement industry. Citing Informa’s Nutrition Business Journal, GAO reported the memory supplements market has practically doubled from 2006 (US$353 million) to 2015 ($643 million), reflecting nearly 2 percent of dietary supplement sales in 2015 ($39 billion).

However, some marketers touting memory supplements are exploiting a vulnerable demographic, misrepresenting product benefits to the brain and even promising treatment for a disease like Alzheimer’s.

In 2015, Sen. Claire McCaskill—then the top-ranking Democrat on the Senate Special Committee on Aging—commenced an investigation of products and retailers in the dietary supplement industry that target seniors using claims that products improve memory and treat dementia and Alzheimer’s disease.

“People looking online for cures or treatment for Alzheimer’s disease and dementia are at their most desperate—and it’s clear from what we’ve found that many of these products prey on that desperation," McCaskill said at the time.

Disease Claims

Now, a government report adds to McCaskill’s concerns. During a two-month review of hundreds of dietary supplements claiming to improve memory, GAO identified nearly 30 examples of advertisements that associated use of the products with prevention or treatment of memory-related disease.

FDA officials, who police dietary supplements for safety concerns and regulate labeling of the products, subsequently determined 27 of the 28 ads appeared to run afoul of federal regulations. The so-called disease claims are generally prohibited, rendering the products unapproved new drugs.

“Studies indicate this supplement may help protect against age-related memory decline, including Parkinson’s disease," one internet ad reviewed by GAO proclaimed.

Declared another ad: “[W]e 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."  

FDA, FTC Enforcement Actions

According to GAO, an independent, nonpartisan agency that works for Congress, two firms addressed FDA’s concerns after receiving “advisory letters" from the agency. Online advisory letters are a relatively new tool used by FDA to fight the online promotion of dietary supplements that purport to treat a disease. The letters provide notice of violations of the law, and they are subject to a shorter internal review process than warning letters.

In February 2017, FDA issued a warning letter to a company that several of its products were suggested as treatments for diseases, including Alzheimer’s, HIV/AIDS, leukemia and Parkinson’s, among several others.

Commenting on GAO’s report, the Council for Responsible Nutrition (CRN)—a Washington-based trade organization representing the dietary supplement industry—acknowledged that such disease claims are fraudulent.

“While promising research demonstrates certain dietary supplements can help to support brain function, the fact is that dietary supplements cannot cure, mitigate, treat or prevent Alzheimer’s, dementia or any disease," observed Steve Mister, president and CEO of CRN, in a statement. “Products that mislead consumers into thinking otherwise are fraudulent and should be avoided."

Added Mister: “We strongly support FDA and FTC taking aggressive enforcement against these fringe marketers, going beyond issuing advisories and taking much-needed regulatory action."

Even before GAO researched the issue, the federal agencies responsible for regulating the labeling and advertising of dietary supplements—FDA and FTC—targeted marketers accused of exploiting America’s aging population.

Between 2006 and 2015, memory products were the subject of 19 of FDA’s 551 dietary supplement enforcement actions, GAO divulged in its report. Seventeen of the 19 actions were advisory in nature, including six untitled letters and 11 warning letters.

But in 2011, the report noted, FDA filed for an injunction against a dietary supplement business and its principals, whose products contained claims to treat and cure Alzheimer’s, among other diseases.

FTC officials advised the GAO, “as the U.S. population ages, health fraud related to memory is becoming an area of increasing concern and focus for the agency."

In January 2017, FTC and the New York State Attorney General alleged in a complaint that the marketers of Prevagen made false and unsubstantiated claims that the dietary supplement improves memory, offers cognitive benefits and is “clinically shown" to work.

Quincy Bioscience has denied the allegations, asserting in court documents that it met the “gold standard" in corroborating its advertising statements. The complaint, nonetheless, is emblematic of regulators’ concerns that older Americans vulnerable to memory loss are targets for exploitation and fraud.

“I think it’s fair to say that right now, the No. 1 priority … in the Division of Advertising Practices at the FTC are products aimed or targeted at the aging population," Richard Cleland, an FTC official, said recently during The Big Natural, an event held in Las Vegas by the Natural Products Association (NPA).

In February 2017, FTC and the Maine Office of the Attorney General announced a complaint and three settlements with dietary supplement marketers over charges of deceptive claims to improve memory and reduce back and joint pain.

Like the millions of Americans who suffer from memory loss, back pain also is prevalent among older people. Many products targeting the aging population are for pain, said Cleland, who added more than 100 million Americans endure some type of pain.

GAO Recommendation

Consumers who are the targets of deceptive advertising and marketing practices may not fully appreciate or understand the roles played by FDA and FTC. For example, while FDA’s jurisdiction over dietary supplements extends to marketing information used in the sale of a product—including supplements marketed on the internet—consumer groups with whom the GAO conferred “were either unaware of FDA’s role with regard to internet sales and marketing of dietary supplements, or said that the shared oversight roles between the two agencies was unclear."

GAO recommended “the secretary of the Department of Health and Human Services [HHS] and the chair of the FTC develop and provide additional guidance to consumers delineating the agencies’ differing roles in their shared oversight of memory supplement and other dietary supplement marketing on the internet."

GAO noted both agencies generally agreed with its recommendation after they received a draft of the report. “Our two agencies have already been in communication about working together to develop materials toward this end," an FDA spokesperson said in an emailed statement.

Before GAO’s report was released to the public in June, it was sent to McCaskill and Sen. Robert Casey Jr., the ranking member on the Senate Special Committee on Aging.

McCaskill currently is the top-ranking Democrat on the Senate Homeland Security and Governmental Affairs Committee.

“Senator McCaskill is continuing to review the [GAO] report, but this is another clear example that dishonest marketing practices within the industry continue to occur and much more needs to be done to protect consumers," said Drew Pusateri, communications director and senior advisor for the Senate Homeland Security and Governmental Affairs Committee under McCaskill, in an emailed statement.

A spokesperson for Casey did not immediately respond to INSIDER’s request for comment.