The FDA’s latest warnings against the dangers of dietary supplements that claim to cure, treat, mitigate or prevent cardiovascular disease have one pharmacist urging the profession to let the agency know when such false claims are being made.

On Nov. 17, the FDA issued warning letters to seven companies for illegally promoting their supplements for a variety of cardiovascular conditions, including atherosclerosis, stroke or heart failure, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 

The FDA warned consumers not to use these or similar products because the agency has not deemed them safe or effective for their intended use, and may in fact be harmful.

C. Michael White, PharmD, FCP, FCCP, the department head and a professor of pharmacy practice at the University of Connecticut School of Pharmacy, in Storrs, explained why the FDA may need the help of pharmacists to protect patients from these deceptive marketing practices.

“Although the FDA has the authority to act, they have limited resources to finding these bad players making false claims,” Dr. White said. 

He pointed out that under the FD&C Act, products that claim to mitigate or prevent disease are justifiably considered as drugs by regulators, and thus subject to the requirements that apply to any medication intended for human consumption. “And that’s the case even if the products are being marketed as dietary supplements,” he told Pharmacy Practice News.

The FDA underscored the need for that higher level of regulatory scrutiny for products marketing to alleviate cardiac conditions. “Cardiovascular disease is the leading cause of death in the United States,” the agency stressed. Thus, “it’s important that the FDA protect the public from products and companies that make unlawful claims to treat it.”

The possibility that patients might choose these dietary supplements over agency-approved prescription medications is another cause for concern, according to the FDA. Such products “could potentially harm consumers who use [them] instead of seeking safe and effective FDA-approved treatments from qualified healthcare providers,” said Cara Welch, PhD, the director of the Office of Dietary Supplement Programs in the FDA’s Center for Food Safety and Applied Nutrition. 

“We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that could put their health at risk,” Dr. Welch said.

Dr. White echoed the need to educate patients about the dangers of leaving prescription cardiovascular medicines on the shelf. “If a patient comes to you and asks about these natural alternatives for lipid management, it’s important to remember that their ability to lower LDL [low-density lipoprotein] is usually small—about 15% or less—whereas statins and PCSK9 [proprotein convertase subtilisin/kexin type 9] inhibitors reduce it by 50% at maximal doses,” he said. “Patients also need to understand there is no proof that these products actually reduce heart attacks and strokes. So, the money spent might not be providing benefits.”

Efficacy Claims That Cross the Line

The FDA’s warning letters on cardiovascular dietary supplements were issued to Essential Elements (Scale Media Inc.); Calroy Health Sciences LLC; Iwi; BergaMet North America LLC; Healthy Trends Worldwide LLC (Golden After 50); Chambers’ Apothecary; and Anabolic Laboratories LLC.

An examination of the letter sent to Healthy Trends Worldwide illustrates the degree to which the FDA is calling these companies to task for making efficacy claims that indicate a product “is intended for use as a drug,” and thus running afoul of the agency’s review process.

In several website statements, Healthy Trends Worldwide claimed its product can “reduce blood pressure” and “add a healthy 10, 15, even 20+ years to your life.” These outcomes were attributed to hawthorn berry and magnesium, two ingredients in the company’s BPS-5 supplement.

The FDA is not convinced. “Your BPS-5 product is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a ‘new drug’ under [FDA law],” the agency stated in a Nov. 14, 2022, warning letter to the company. “With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA.”

Counseling Tips

As for other claims often made by companies marketing cardiovascular supplements, Dr. White cited statements regarding LDL cholesterol as particularly problematic. “Consumers are being told that these dietary supplements are effective at reducing LDL cholesterol, which in turn lowers the risk for heart disease. But aside from statins, ezetimibe [Zetia, Organon] and the monoclonal antibody PCSK9 inhibitors, there is no proof that these products can reduce atherosclerotic events.”

But it’s not just a question of a lack of efficacy. As the FDA rightly warned, these dietary supplements can be harmful, Dr. White stressed. 

“There is limited information on adverse events and drug interactions because the products are not well studied,” he said. “This is problematic especially for patients on other medications and with other diseases. For example, red yeast rice, a common ingredient in supplements marketed for lipid lowering, contains natural lovastatin, so it must also be a CYP3A4 [cytochrome P450 3A4] substrate inhibitor and would therefore accumulate if combined with itraconazole or grapefruit juice.”

Similarly, “some products containing natural statins or niacin could negatively affect the liver, and so in an ideal world, liver function testing would be done for patients who take them.” But if a patient is ingesting them on their own—as usually is the case with over-the-counter products—there is no opportunity for a clinician to order such tests, he noted.

“Finally, unless the products are certified by an independent laboratory, they could be contaminated with heavy metals and microbes or adulterated with prescription drugs,” Dr. White said. 

And then there’s the question of cost. “In many cases, generic statins are less expensive than the so-called ‘natural’ products these companies are marketing,” he said. 

Coupled with the fact that FDA-approved cardiovascular medications “are more effective, do not have contamination or adulteration, and your pharmacist can watch out for drug interactions and other adverse events,” he said, it’s clear that caveat emptor should be the main message when the subject of these supplements come up during patient encounters.

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