No treatment has been shown to stop or reverse the progression of Alzheimer’s disease. Yet, an abundance of alternative therapies for Alzheimer’s disease are available over the counter (OTC) with no reputable scientific research to support them.
In February 2019, the FDA took aim at 12 sellers of so-called Alzheimer’s supplements that falsely claim to prevent, treat, or cure the disease despite no proof of, nor biological plausibility for, the products’ effects. The agency had previously sent advisory letters to five online companies in November 2018. Such companies take advantage of the lack of legitimate Alzheimer’s treatments to prey on vulnerable patients and their loved ones desperate for a cure.
In total, the FDA identified 58 products such as pills, tablets, and oils being illegally marketed and sold, mostly as dietary supplements. Many products have suggestive brand names like Mind Ignite, Cognispark, and Memory Revitalizer.
While several prescription drugs approved by the FDA to treat Alzheimer’s disease are available for people in the early or middle stages of the disease, they can only slow down some symptoms, such as memory loss, for a time. Even so, there’s a $3.2 billion market for OTC products claiming to promote brain health. These costly products are offered by companies that operate outside regulations or illegally, often marketing on websites and social media sites like Facebook and Instagram with little oversight. The manufacturers sometimes tout “clinical studies” that are poorly designed or lack scientific rigor and sometimes published in journals with low standards. The products may even be promoted by a (shady) medical professional.
Some patients may be vulnerable to persuasive marketing techniques used to sell “pseudomedicine”—questionable supplements or medical interventions sold within the law but with no credible data to back up their health claims. Such products offer false hope and delay appropriate care for patients who would otherwise seek legitimate therapies from licensed health care providers.
What’s more, because these products aren’t tested by a regulatory agency, they are not only ineffective but also potentially unsafe and could cause serious harm from side effects or interactions with other drugs.
The FDA’s role
The FDA isn’t authorized to test dietary supplements for safety or effectiveness because supplements are regulated as food, not drugs. It’s up to the manufacturers and distributors of these products to ensure they’re safe. Because of the minimal regulation of supplements, there’s no way to be sure how much, if any, of the active ingredient on the label is in the product, whether it works or is safe, or if the product contains other potentially harmful substances.
Despite being prohibited from making health claims that their products can prevent, diagnose, treat, or cure diseases, some companies cross the line, or come dangerously close to it, by creatively using language and testimonials to imply certain benefits without stating them outright. Personal experiences are powerful and compelling, but what works for one person may be harmful to someone else.
The red flags
Even the best informed among us can be swayed by promises of “scientific breakthroughs” when faced with a serious health problem. But if claims contradict what we’ve heard or read from reputable sources and seem too good to be true, they probably are. According to the FDA, false claims often include wording like:
- “You can even reverse mental decline associated with dementia or even Alzheimer’s in just a week”
- “Clinically shown to help disease of the brain such as Alzheimer’s and even dementia”
- “Supplements are used to cure Alzheimer’s disease”
- “Can reduce the risk of Alzheimer’s by half”
- “May have a role in preventing the progression of Alzheimer’s”
Products may purport that the cure extends beyond Alzheimer’s disease to other neurological disorders, such as other dementias and Parkinson’s disease, as well as to unrelated conditions like cancer, diabetes, obesity, male infertility, and depression. Unfortunately, it’s difficult for the FDA to crack down on many companies and their products. Once a company receives an FDA warning letter, it has 15 business days to respond and explain how it plans to correct the violations. However, the company can elude the agency by simply moving to another website.
The FDA recommends that consumers steer clear of products that make sweeping claims without scientific data to back them up. Consider that if these products were that effective, their use would be widespread and generally accepted. Still unsure? Check with your doctor before buying or using any of these products.
This article first appeared in UC Berkeley Health After 50.
Also see Can Supplements Improve Memory?