A study published in JAMA Network Open on October 12th by Jenna Tucker et al looked at the Food and Drug Administration’s (FDA) list of dietary supplements that have tested positive for unapproved and unlisted drugs.
The study examined 776 products. Nearly 80% contained one hidden ingredient; the other 20% tested positive for two or three ingredients. Most of them were found to be adulterated on one occasion, but a few had failed tests twice, and a handful had failed them three times. Two-thirds of the products that received second or third warnings listed new ingredients on the successive warnings, which was particularly disturbing to the researchers as it indicated that the product continued to be sold after the FDA became aware of the adulteration.
The FDA’s website currently lists 922 products. The difference between the number of products included in the study and the number of products on the list is due to the two factors: first, the data was taken on February 28th, 2017, and a number of products have been added since then; second, the study notes that a warning document might name multiple products or multiple warnings might name the same product.
The tainted products included a range of hidden ingredients, from sibutramine (withdrawn from the U.S. market in October 2010 due to cardiovascular risks) to phenolphthalein (often used in laxatives) to sildenafil (the branded version of which is known as Viagra).
The products all fall into certain categories. Weight loss and sexual enhancement account for the vast majority. Muscle building makes a strong appearance, one product falls into the prostate health category, and a handful of them are categorized as “other.”
The Council of Responsible Nutrition released a statement reminding consumers that the products listed by the FDA are not only unsafe, they are illegal. Customers should avoid purchasing products with “outrageous” names sold by unfamiliar brands and companies, or through disreputable retailers or distributors. Furthermore, products marketed as dietary supplements that have “drug-like claims” or promise unrealistic results—especially in the sexual enhancement, weight loss, or muscle building categories—should be avoided. And, of course, customers should talk to a doctor before starting a dietary supplement.
Dr. Daniel Fabricant, head of the Natural Products Association and former FDA official, released a statement to reassure retailers and consumers. “The safety record of the dietary supplement and natural products industry is far superior to prescription drugs because of a strong federal regulatory regime and significant investment in product safety and quality,” he said, along with a reminder that even if the study’s estimates for hospitalization caused by tainted supplements were accurate, those hospitalizations would represent .0001687% of the total number of yearly visits.
As the United Natural Products Alliance noted, there may be news coverage on this; NPR already posted an article. While this is unlikely to make or hold front-page status, there is the definite possibility that your customers will have questions.
To that end, it’s time for the good news: the list is searchable. Depending on your stock, it might take some time to go through all your weight loss, sexual enhancement, and muscle building products, but not nearly as long as it otherwise would. And you’ll be able to reassure everyone who comes through your doors that your products are safe.