In addition to the warning letters, FDA also sent ‘advisory letters’ to an additional four companies making cancer claims on their products. The action was announced via an update for consumers warning them about the products, which the agency said were sold most commonly via internet portals or via social media platforms.
The companies that received warning letters appeared to all be selling products positioned as dietary supplements (this could not be verified in all cases as some web addresses are now listed as inactive). As is often the case with many agency enforcement actions, the companies caught in the web appear to be small players that fly mostly under the radar.
Major player warned
In this case, however, a major company popped up, and one that belies the online sales aspect of the others: LifeVantage Corp., a network marketing company based in Sandy, UT that sells an herbal dietary supplement called Protandim NRF2 Synergizer. Publicly traded LifeVantage recorded $48 million in quarterly sales in its most recent earnings statement.
In the LifeVantage warning letter, FDA mentioned that the company states in several places on its website that its product prevents or minimizes the risk of various cancers. But it went on to make other impermissible claims, including:
“Nrf2-activating phytonutrients such as EGCG from green tea, curcumin from turmeric, and quercetin from onions are known to reduce amyloid plaque accumulation (Alzheimer’s) and increase regeneration of dopamine fibers (Parkinson’s), suggesting a general neuro-protective benefit,” according to the warning letter. LifeVantage had not yet responded to request for comment from NutraIngredients-USA.
A blizzard of dietary ingredients that the companies claim could prevent cancer is covered by the warning letters. The 14 companies sell products that include ashwagandha, astragalus, asparagus extract, burdock root, curcumin, EGCG, quercitin, sulforaphane, sour sop, vitamins and more.
FDA has taken concerted action against illegal clams in other cases. Examples include actions against companies claiming their products could cure or ameliorate the symptoms of SARS or H1N1. Grouping all of the warning letters into a single action is a favored tactic at FDA, said attorney Ivan Wasserman, a partner in the firm Amin Talati Upadhye.
“We do see FDA do sweeps like this from time to time. They did it with SARs, with H1N1. Rather than send out the warning letters by ones or twos they do a sweep like this and get more enforcement bang for their buck,” Wasserman said.
In the case of those other conditions, FDA was seeking to shut down marketers who appeared to be trying to capitalize on a current disease trend. The agency also sent out three warning letters on Ebola in a similar action. But cancer, it seems, will ever be with us, and the companies claiming illegally to treat it seem as if they will be, too. So in that light, Wasserman speculated that this action might be timed to get a jump on any enforcement relaxation under the Trump Administration.
“This might be FDA’s attempt to get this out there before they get a new commissioner, maybe as a signal to the market not to expect a free ride under the new administration,” he said.