On Monday, FDA announced a sweeping enforcement action on Alzheimer’s claims. The agency issued 12 formal warning letters and five online advisories to companies that in the agency's view were claiming to treat the condition based on what they were saying about their products on their websites.
Ten of the companies that received formal warning letters are located in the United States. One is located in Canada and another in India. The US based companies were broadly distributed geographically. Nine states were represented in the list (two companies were in Florida).
All types of ingredients represented
Some of the 12 companies marketed products with ingredients that are commonly grouped into the nootropic category of ingredients or those thought to have cognitive effects. These included AlphaGPC, Bacopa monnieri, phosphatidylserine and St. John’s Wort.
But the wide range of ingredients included in the products showed that marketers across the spectrum of the industry have fallen victim to the temptation to include Alzheimer’s disease treatment claims in their marketing language. Other ingredients included in the enforcement action include omega-3s, green tea extract, avocado oil andCoQ10.
Some of the ingredients fall into the penumbra of smart drugs: Noopept, piracetam, phenylpiracetam, aniracetam and phenibut. The American Medical Association sent out an advisory to doctors on these ingredients in 2016.
Capitalizing on fear
This is hardly the first time that unscrupulous marketers have sought to capitalize on public fears. For example, there have been prior FDA advisories and enforcement actions against marketers who were making claims related to the SARS outbreak in 2003 and the rise of the Ebola virus in West Africa in 2014.
While Alzheimer’s disease is not an epidemic like those were, the rise in public concern about the condition bears some resemblance to the fears fueled by those outbreaks. A study done in 2011 found that 31% percent of respondents listed developing Alzheimer’s as their No. 1 health concern when choosing from a list that included cancer, heart disease, stroke and diabetes. By 2018, 62% of respondents in what was billed as the largest survey to date of its type said they were worried about developing the condition.
Memory, cognition claims still OK
Ivan Wasserman, an attorney in the firm Amin Talati Upadhye, said that while the FDA enforcement action is not good news for the marketers of cognitive support products, there is still plenty of room to maneuver for companies making carefully crafted claims.
“Memory claims and cognitive support claims are still allowable. Alzheimer’s claims, of course, are not,” Wasserman told NutraIngredients-USA.
“You can make claims like ‘supports healthy memory function’ or ‘supports cognition.’ As far as memory loss goes, FDA has allowed claims that speak to the normal or mild age related cognitive decline. We all tend to forget things more easily as we age,” Wasserman said.
Lack of effective drug therapies
One of the primary concerns for FDA when it comes to illegal disease claims is the danger that a consumer might be misled into trusting a cynically marketed supplement and forgoing a proven drug treatment that might have saved or prolonged their life. In the case of Alzheimer’s disease, the available drug treatments are at best only mildly effective, with the strongest claim out there being to slow the progression of the condition for six months. And the drugs have some unpleasant side effects.
While that might alter the moral outline of the issue (a cancer sufferer wasn’t duped into declining life saving surgery or chemotherapy, in other words), it doesn’t change the legal one, Wasserman said. Even if there isn’t much that can be done on the pharmaceutical side for Alzheimer’s sufferers, for supplements, it’s still hands off.
Nevertheless, for age related cognitive decline, supplements can still have a role to play, Wasserman said. There is much that not understood about Alzheimer’s, including how ARCD and full blown Alzheimer’s might be connected. Can one be the precursor of the other, or are they completely unrelated conditions?
People reporting symptoms of ARCD are technically still ‘healthy.’ People diagnosed with Alzheimer’s are not. So studies involving these two populations would function differently from a substantiation standpoint, Wasserman said.
“If you were to try to make some type of Alzheimer’s claim, then you’d be back in the old supplement catch 22, that being that you’d have to have substantiation, which would be a double edged sword. For that you’d have to have a study in a diseased population. Then you’d be a drug,” he said.
