How Shady Are Supplements? The FDA Says Shady.

While many are familiar with the fact that there is very little regulation on the ingredients and labeling of supplements, the FDA weighed in this month on how shady the supplement industry is. The FDA has had more than thirty years to apply some enforcement structure on supplement ingredients, and today the trustworthiness of the supplement industry is likely worse than it was thirty years ago. The FDA doesn’t have direct approval authority over supplements, but a supplement maker is supposed to disclose new ingredients with safety measures. Millennials were raised on Flintstone vitamins. Whole Foods and Sprouts dedicate large portions of their stores to supplements. Supplements have become a part of daily life and are often recommended by doctors. Since 1994 the supplement market has grown from offering about 4,000 products on shelves to somewhere between 50,000-80,000 today. The FDA admits that in the same time span, supplement manufacturers have only shared about 1,200 new ingredients with the agency. In May, the FDA estimated supplement makers haven’t informed them of approximately 3,400 new ingredients that are being marketed today. According to Stat News, the last time the FDA made an attempt to clarify and enforce ingredient disclosure on supplements was in 2016. Each time the FDA tries to draft new guidelines to enforce supplement regulation, the manufacturers respond by saying that the guidelines aren’t clear enough. For instance, “FDA doubled down and simply increased the length of the guidance from 86 to 102 pages,” the law firm Hyman, Phelps & McNamara wrote in comments in 2016. The most enforcement the FDA has put on manufacturers not disclosing ingredients is writing a strongly worded letter. At the same time, when manufacturers have disclosed ingredients, the FDA has shut them down. For example, two CBD companies who took the initiative to report their ingredients were told, “CBD is not considered a dietary supplement under federal law.”

Meanwhile, last week Pendulum mentioned the popularity of melatonin as a natural sleep supplement. This week a report was published concerning a rise in melatonin poisoning in children. It disclosed five children were recently hospitalized, and two infant fatalities.

Melatonin sales increased 150% from 2016-2020 and some of these included melatonin gummies that are marketed to children. According to NPR: In the U.S., melatonin is sold as a supplement, not regulated as a drug. Because melatonin is unregulated, the U.S. Food and Drug Administration doesn't have oversight over the purity of ingredients or the accuracy of dosage claims. Other researchers have found that what's on the label may not match what's actually in the bottle, and some countries have banned the sale of over-the-counter melatonin.”