Super Bowl Brings Deer Antler Back in the Spotlight

In the usual search for attention-grabbing stories leading up to the Super Bowl, the focus on Baltimore's leader Ray Lewis has propelled deer antler velvet back into the spotlight. Reports have linked Lewis to a deer antler velvet product from S.W.A.T.S. called the Ultimate Spray.

S.W.A.T.S , which stands for Sports With Alternatives to Steroids, offers purported performance-enhancing products to athletes, including other NFL stars and top college football playersnew National Champion Alabama has several players indicated. This two-man show from Alabama hawks radio chip stickers, negatively charged water and deer antler sprays with the promise of improved strength and performance.

The question of specific players' involvement and what that might mean for their careers and teams is for others to investigate and determine. For the natural products industry, there are many eyes on this deer antler news at a time when scrutiny is increasing on sports supplements, especially energy-related products. This new attention on deer antler has brought to light questions of regulation, safety and responsibility.

First of all, this is not the debut for deer antler controversy, or even NFL's involvement. In Early 2011, the NFL sent letters to several players thought to be associated to S.W.A.T.S. and Ultimate Spray, which the company has consistently claimed contains growth factors including IGF-1 (insulin-like growth factor-1), erythropoietin (EPO), methyltestosterone and other anabolic compounds. The NFL and the World Anti-Doping Agency (WADA) have banned IGF-1, which is taken by athletes for its promises of making them stronger and faster.

[Editor's note: In June 2011, St. Louis Rams linebacker David Vobrora won a $5.4 million judgment in his lawsuit against S.W.A.T.S. (dba Anti-Steroid Program LLC) for undisclosed methyltestosterone in the Ultimate Spray, which he blamed for his positive doping test and resultant suspension by the NFL. Shortly after the case, the company changed it's name to S.W.A.T.S.]

However, the inclusion of a banned substance is a matter between athletes, their leagues and sports governing bodies. The supplement industry is concerned with the legality of a product and its marketing. In fact, in 2010 the Council For Responsible Nutrition (CRN) asked FDA to look into S.W.A.T.S. and the spray, which is intended to be taken sublingually.

Duffy MacKay, N.D., vice president of scientific and regulatory affairs for CRN, wrote the letter to several people at FDA, including CDER and CFSAN, trying to get their attention and prompt them to look at the company and product holistically. "I pointed out the obvious red flag that the company was calling it a spray and touting, even to this day, sublingual delivery," he said. The company is up front about its belief that its spray's sublingual delivery offers absorption advantages superior to common oral delivery systems used in many supplements, MacKay noted. "In my letter, I referenced a past FDA warning letter where it stated sublingual delivery rendered a product a drug."

What MacKay received later that year was a standard response from FDA saying, basically, the agency appreciated the heads up, but it had no comment or update to the regulatory status of S.W.A.T.S. or its deer antler spray. "When a case is in a 'gray area,' it tends to move down the totem pole of priority for FDA, but when the evidence is black and white, the agency has a clearer path for further action," MacKay explained. He said with all the renewed and heightened attention currently on the company and the spray, as well as the company's seemingly brazen acceptance of the negative, but widespread exposurethe recent Sports illustrated article that blew up the story contains several comments from company owners about how great the publicity has been and how it's up to science to disprove their products' benefits; see more evidence in this AP storymight finally catch the attention of regulators, who could also find many red flags at the product's website.

Industry lawyers confirmed FDA's position that sublingual delivery renders a product a drug. FDA's past warning letters to products marketed as a supplement but using sublingual delivery provide further evidence of the agency's position. Through its spokesperson, FDA's Division of Dietary Supplements told me: "As supplements are intended for ingestion by statute, which means they are absorbed in the stomach or intestines, buccal tissue or sublingual absorption would not be considered ingestion." The agency also cited case law (U.S. vs. NBTY, 1995).   

Then, Is deer antler a dietary supplement? In conferring with supplement industry regulatory experts, I learned deer antler is on the industry's list of Old Dietary Ingredients (ODI), meaning it was marketed as a food or supplement before October 1994. 

FDA told me the agency has never objected to deer antler velvet. "However it would likely have to qualify as a dietary substance for use by man to supplement the diet by increasing the total dietary intake," the agency explained, noting deer antler isn't is a vitamin, mineral, herb/botanical or amino acid.

The challenge comes from the specific characteristics of each deer antler product. Although the draft guidance on new dietary ingredient (NDO) notifications is being revised by FDA, at some point any dietary ingredient considered "new" will need to file such a notification with the agency. While industry has put deer antler on its ODI lists, these lists are not officially recognized by FDA, so how each deer antler product is considered by the agency, after the final rule is issued, will depend on several factors.

About deer antler, FDA told me: "Regarding an NDI, that would depend on whether or not the product was chemically altered from what possibly qualified as a dietary ingredient prior, and when it was first marketed." This is a stock answer, but it suggests some deer antler products could face NDI notification requirement, while others may not.

At the very least, I'd think FDA would take issue with any such products intended for sublingual delivery and promising growth hormone and anabolic benefits. MacKay pointed out there also is the question of whether the S.W.A.T.S. facility adheres to dietary supplement GMPs(good manufacturing practices), which demand numerous documentation, process and testing practices to ensure quality controlseveral news articles noted the company operates out of the back of a gym in Birmingham, Ala.

Until FDA investigates the company and its product and takes any further action, the publicity rages on, sure to swell even higher over the next few days leading into the Super Bowl this Sunday. While S.W.A.T.S. has always been a smaller playerFDA mentioned managing its resources in its response to CRNthis hoopla may bring negative attention to the dietary supplement industry. "Anytime a company chooses to push the envelope this much, it could have negative implications for the responsible companies in the supplement industry," MacKay said, noting it could  increase the risk of losing credibility and ingredients. "There are tons of responsible companies in this industry."

This, however, apparently means nothing to S.W.A.T.S. owners, who seem to take pleasure in defiance. "It's been the best thing that could have happened. It's been fabulous," said SWATS co-owner Christopher Key, in the AP article.