ARTICLE IN BRIEF:
Alzheimer's disease specialists applauded the US Food and Drug Administration action warning companies to cease making false marketing claims about the efficacy of dietary supplements for dementia.
For neurologists whose patients ask about dietary supplements to prevent memory loss, the U.S. Food and Drug Administration (FDA) warning to companies promoting these products couldn't come soon enough. The action by the federal agency underscores a message they often provide their patients, several clinicians told Neurology Today.
“I am often approached by patients and their families when they start having memory loss, as well as by people who are worried and interested in decreasing their risk of Alzheimer's,” said Douglas Galasko, MD, professor of neurology at the University of California, San Diego.
“I usually try to find out where they obtained the information, and then discuss, as respectfully as possible, that there are different sources and levels of claims for evidence in medicine. I try to point out the lack of rigorous evidence for the vitamins and supplements, the lack of positive clinical trials, and the absence of FDA approval of supplements for Alzheimer's disease. I also mention variability in the manufacture of supplements, and patients can't always know exactly how pure the supplement is or its dose, and there is potential for problems ranging from side effects to interactions with prescription medications.”
The lack and evidence and shaky promotional claims were the cause for the February 11 announcement from the FDA. The agency had sent 12 official warning letters and five online advisory letters to companies selling more than 58 supplements, many of which were marketed online or on social media. In its statement, the FDA stressed that the products have not been proven safe and/or effective and could potentially prevent a person from seeking medical help.
Many of the cited products also make claims for being beneficial for patients with other diseases, including Parkinson's and Huntington disease, vascular dementia, and recovery from brain injury.
The crackdown is part of a larger effort aimed at overseeing and regulating the supplement industry that has witnessed explosive growth in recent decades, former FDA Commissioner Scott Gottlieb, MD, said in a statement accompanying the announcement.
“What was once a $4 billion industry comprised of about 4,000 unique products, it is now an industry worth more than $40 billion, with more than 50,000—and possibly as many as 80,000 or even more—different products available to consumers,” noted Dr. Gottlieb, who announced on March 5 that he was stepping down in April as commissioner.
The FDA told the supplement manufacturers that their products violate the Federal Food, Drug, and Cosmetic Act. Companies were ordered to respond within 15 days of receiving letters and explain how the violations will be corrected. Failing to promptly correct the violations could result in legal action, product seizure, and/or an injunction, the agency said.
The FDA has sent more than 40 warning letters over the last five years to companies illegally marketing over 80 products in violation of the Federal Food, Drug, and Cosmetic Act. But the FDA noted they continue to make unproven claims for many unsafe and unapproved products, which are sold “due in part to the ease with which companies can move their marketing operations to new websites,” the agency said.
The warnings came as part of broader FDA initiative to provide a flexible regulatory framework to uphold safety and integrity of supplements, including quickly alerting the public about products that may contain unlawful or potentially dangerous ingredients.
Cited manufacturers were warned that their products “are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner.”
Among the companies issued warning letters were:
- Gold Crown Natural Products, headquartered in Miami, FL, which claims its Colostrum Ultra, “has benefits for patients suffering from Alzheimer's disease”;
- TEK Naturals, in Mt. Pleasant, NC, which says ingredients in “Mind Ignite” are “clinically shown to help diseases of the brain such as Alzheimer's and even dementia”; and
- Pure Nootropics, of Albuquerque, NM, which promotes its product Alpha GPC as “helpful in reducing symptoms of cognitive decline and one of its ingredients, citicoline, has been proposed for use in traumatic brain injuries, stroke, vascular dementia, [and] Parkinson's disease.”
Dr. Galasko told Neurology Today he believes the FDA's efforts will prove helpful in reinforcing his messaging to patients. He added, too, that statements about the false claims from professional bodies such as the AAN, American Geriatric Society, and organizations about the Alzheimer's disease association discussed in these studies would be helpful.
Neurologists also can more actively educate their patients about the false claims, said Oscar L. Lopez, MD, FAAN, professor and director of the Alzheimer's Disease Research Center at the University of Pittsburgh. Dr. Lopez said he advises families that there are no published studies showing any benefits, and often refers families to the Alzheimer's Association website. “Even so, not much more can be done,” he told Neurology Today.
“There is no way to stop them from using such supplements,” he said. “We try to educate our patients about the lack of evidence, however it is human nature to try to do something to fight back against diseases like Alzheimer's with compounds being legally sold in supermarkets, health food stores, and on the internet.”
Cost, Safety Concerns
Joshua W. Miller, PhD, professor and chair of the department of nutritional sciences at Rutgers, the State University of New Jersey, said he and his colleagues have conducted several epidemiological studies looking at associations and relationships between specific nutrients in supplements and cognitive function, cognitive decline, and risk of AD and dementia in older adults.
“There obviously are diseases caused by vitamin, mineral, and essential amino acid deficiencies, but supplements for these are not ‘drugs’ because deficiency diseases are well established. However, when claims are made about dietary supplements curing, mitigating, treating, or preventing diseases, they are no longer considered dietary supplements, but drugs by the FDA,” he explained.
Patients and the family members have often spent large amounts of money buying these and similar supplements lacking any solid clinical evidence of improving their symptoms, added Jonathan Graff-Radford, MD, FAAN, a co-investigator at the Mayo Clinic Alzheimer's Disease Research Center, in Rochester, MN, who studies mild cognitive impairment, vascular cognitive impairment, Alzheimer's disease, Lewy body dementia, and other neurological disorders.
“It is important that clinicians who see patients with cognitive concerns take the time to educate them regarding these supplements and understand the motivation behind the request rather than dismissing the patient's questions without discussion,” he told Neurology Today.
“We tell them we cannot recommend supplements because they have not been through vigorous clinical trials and their safety and efficacy are unknown. However, some supplements that they ask about have been tested in clinical trials. When a supplement has been studied, such gingko biloba, I share with them the results from research trials.”
For example, he said, a seminal randomized, placebo-controlled trial published in 2008 in the Journal of the American Medical Association by neurologist Steven T. DeKosky, MD, FAAN, and colleagues showed twice-daily doses of 120-mg extract of gingko biloba did not reduce the overall incidence rate of dementia among elderly individuals compared with a placebo.
Dr. Graff-Radford said he discusses with his patients the healthy behaviors they can engage in that have potential cognitive benefits, including performing cardiovascular exercise, eating a healthy diet, and staying cognitively active.
Product safety is another factor to consider, he said. “Just because a supplement claims to be ‘natural’ that does not mean it is safe, especially in large doses. Also, supplements and their ingredients may interact or interfere with other medications a patient might be taking.”
Dr. Galasko has received consultant fees from vTV Pharmaceuticals, LLC, for service on its advisory board, as well as fees for service on the data safety monitoring committee for Cognition Therapeutics, and for his service as editor-in-chief of Alzheimer's Research & Therapy. Dr. Graff-Radford receives an honorarium from the AAN for speaking and writing for Continuum.