Cancer claims, CBDs and SARMs highlights of 2017 enforcement picture

21-Dec-2017 - Last updated on 21-Dec-2017 at 18:17 GMT

The picture painted by warning letters issued by FDA in 2017 is a chiaroscuro of old and new. Familiar enforcement action on claims language contrasted with warnings on the use of new, unapproved ingredients.

On the disease claims front, the big news was the Big C. Legal experts contacted by NutraIngredients-USA have said repeatedly that there is no better way to rouse FDA to vigorous enforcement action than by claiming to treat cancer with your dietary supplement product. Yet some companies, either out of ignorance or because they hope to move some product before they are discovered, still make these claims on their supplements.

In April, the US Food and Drug Administration sent warning letters to 14 companies about marketing products using illegal cancer treatment claims. The agency also sent out ‘advisory letters’ to an additional four companies. The companies that received warning letters appeared to all be selling products positioned as dietary supplements (this could not be verifed 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 said the company was also claiming to help prevent Alzheimer’s disease and Parkinson’s disease with its product.

A blizzard of dietary ingredients that the companies claim could prevent cancer are covered by the warning letters. The 14 companies sell products that include ashwagandha, astragalus, asparagus extract, burdock root, curcumin, ECGC, quercitin, sulforaphane, sour sop, vitamins and more.

Group action

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.

New ingredient concerns

Another warning letter sweep concerned a dietary ingredient relatively new to the market–CBD–derived from a familiar source: cannabis. In early November FDA sent warning letters to four companies marketing CBD dietary supplements, a move that signaled a hardening of the agency’s attitude toward this ingredient. The agency has ruled that CBD (or cannabidiol, a family of several compounds that are a non narcotic fraction of cannabis) is not a legal dietary ingredient primarily because it has been the subject of drug development by English company GW Pharmaceuticals. In the 21 CBD warning letters the agency sent out in 2016 and the 18 such letters mailed in 2015, the agency soft-pedaled this view, saying that it was unaware of any evidence showing that CBDs were on the market as dietary supplements prior to the filing of GW’s Investigational New Drug applications. If that could be proven to be the case, then CBDs would be good to go, at least as far as the IND question is concerned. There are still the other regulatory hurdles involved with the development of products based on cannabis and its various cultivars.

Now, however, the agency has this to say: “It is a prohibited act under section 301(ll) of the Act (21 U.S.C. 331(ll)) to introduce or deliver for introduction into interstate commerce any food to which has been added a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, unless the drug was marketed in food before any substantial clinical investigations involving the drug were instituted. The existence of substantial clinical investigations regarding CBD has been made public. Based on available evidence, FDA has concluded that section 301(ll) prohibits the introduction into interstate commerce of any food to which CBD has been added.”

“I am surprised that FDA waited as long as it did to make this argument. I don’t have a good explanation for that delay, other than they may have been reluctant to engage in a fight for which they did not feel they had the support for,” said Jason Sapsin, an attorney in the firm Faegre Baker Daniells.

New sports nutrition ingredients

The third big warning letter sweep in 2017 also took place in November and concerned the use of SARMs, or selective androgen receptor modulators. These substances have steroid-like effects, but have the advantage for developers of sports nutrition products being marketed as dietary supplements of being technically outside the definition of a steroid and thus not subject to enforcement under the Designer Anabolic Steroid Control Act. FDA issued a consumer warning about products containing SARMs and sent warning letters to three companies at the same time. According to FDA, among the dangers associated with SARMs are liver toxicity and the potential to increase the risk of heart attack and stroke. But the agency said the long-term effects of these substances on the body are unknown.

“We are extremely concerned about unscrupulous companies marketing body-building products with potentially dangerous ingredients. Body-building products that contain selective androgen receptor modulators, or SARMs, have not been approved by the FDA and are associated with serious safety concerns,” said Donald D. Ashley, JD, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We will continue to take action against companies marketing these products to protect the public health.”

FDA spokeswoman Lyndsey Meyer said the problem extends well beyond the three companies that received warning letters. From a simple time and manpower perspective, FDA has to take action where it can have the biggest multiplier effect, she said.

“A warning letter is not something we can get out quickly,” Meyer told NutraIngredients-USA. “These are highly resource intensive. From a resource perspective, we could never send a warning letter to every company at once. We try to go after companies that represent a ‘best snapshot’ of the issue. The message to other companies is ‘you could be next.’”