FDA Lists Four Unlawful Ingredients in Supplements
​[Thursday, April 18, 2019]

Earlier this year, FDA had announced that it would publish a list of unlawful ingredients in dietary supplements, and this week it did. FDA’s list contains four ingredients. The list appears pretty underwhelming particularly because it was highlighted with an accompanying blog by FDA’s Deputy Commissioner for Food Policy. It is hard to imagine that among thousands of ingredients used in dietary supplements, only 4 are unlawful. To be fair, the listed unlawful ingredients are known by many aliases which add-up to 30 names, but even then, the list seems much shorter than one would expect. Does it mean that of more than 90,000 supplement products available to consumers in the US, there are only an infinitesimally small number of products that are unlawful? And FDA clarifies, unlawful does not mean unsafe. This list is among a series of activities FDA announced earlier this year to regulate dietary supplements but on its own the list is confusing at best. It advises consumers “may wish to avoid purchasing or consuming dietary supplements that include these ingredients” which does not seem like an outright warning about dangerous ingredients. It also states that “Retailers, manufacturers, and other businesses may wish to avoid selling, making, or distributing dietary supplements that include any of the above ingredients” which also seems like it is an optional act. If it is unlawful, why it seems that it is optional to include these ingredients? In the announcement accompanying the release of the list claims that FDA “will not stand by and allow these companies to compromise the health of the very people” but the list on its own seems toothless. FDA is routinely taunted by bad players in the dietary supplement industry. Numerous supplement products openly make claims that could be interpreted by the consumers to tout medical benefits, sales agents make off label claims, quality of the products is compromised, and new ingredients are constantly added without proper clearance. The same announcement informed for 11 companies issued Warning Letters to stop selling new dietary ingredients. The Warning Letters to supplement companies are also mostly toothless as the companies can simply stop selling the products, change names and start back-up in no time. Such announcements and Warning Letters from FDA by themselves will not suffice to reign in the supplement industry; there is need for meaningful action by the FDA.