Shortly after the beginning of the pandemic, FDA in cooperation with FTC began issuing warning letters based on website reviews of companies making disease treatment claims on their products and their purported effects against the novel coronavirus.
Claims started appearing thick and fast in the marketplace shorting after the scale of the problem in Wuhan, China first became known. Other global health crises, such as the outbreak of the Ebola virus or SARS, have also seen disease claims proliferate among supplement marketers.
But the scale of the current crisis and the growth of the marketplace since those earlier disease outbreaks has spurred FDA to take special action. The Agency has set up a dedicated list of companies deemed to have stepped over the disease treatment line. The list includes a variety of companies, including those selling medical devices and topical products. Once on the list the companies have only 48 hours to respond to FDA to show that they have expunged the disease claims from their websites and social media accounts. With the addition of the latest warning letters the list stands at 90 entries, with at least 50 of those pertaining to dietary supplement companies.
TCM companies over represented in latest round of warnings
Of the seven recent warning letters, four pertained to TCM products. There has been much interest among herbal products experts about how botanical-based preparations have been used in China as adjuvant therapies in the treatment of COVID-19 cases there. Unfortunately, much of that information is difficult to fit within a DSHEA-compliant disease treatment claim, and as far the Agency is concerned, these four companies stepped over that line.
For example, a company identified as Shen Clinic LLC, based in Albany, CA, had this to say on its website: “TCM’s age old methods for treating fever and cough are being successfully used against corona as they were the SARS epidemic of 2003. . . . Combining Western medicine and TCM appear to be the best approach to treating Covid-19.”
Another company, Lotus Herbal Supplements based in Portland, OR, had this to say in a video on its website: “It’s scientifically proven that TCM is effective against novel coronavirus.”
Of the other two cited TCM companies, one was located in South Carolina while the other was only identified via its website address.
Claims still up on one website
In the other three warning letters, two were sent to companies marketing herbal tinctures. Even though FDA has clapped the 48-hour deadline on these warning letters, one of those companies, identified as Health Beauty Love, is still saying this on its website today: Try E-Munity Tincture to combat COVID19!” FDA’s warning letter to this company was dated July 10. The third of the non-TCM warning letters was sent to a company making COVID-19 treatment claims on its vitamin C products.