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Spirit of Sport Newsletter – Winter 2013-2014
The makers of a popular and controversial supplement were recently forced by government order to cease operations.
Alabama law enforcement officials raided the headquarters of S.W.A.T.S (Sports with Alternative to Steroids) Fitness and Performance in September 2013, based on claims that the company made about a number of products that were unsupported by scientific research. Some of these products were marketed as “dietary supplements.”
One in particular, the “Ultimate Spray,” was advertised as a liposomal preparation of deer antler velvet intended for absorption under the tongue (sublingual). Liposomes are similar to fat droplets that more effectively carry a drug through, in this case, the tissues under the tongue. Deer antler velvet is ground-up material obtained from antlers that is harvested before they harden. S.W.A.T.S further claimed that the active ingredient in the “Ultimate Spray” was insulin-like growth factor-1 (IGF-1), a substance banned both in- and out-of-competition on the WADA Prohibited List.
S.W.A.T.S first came into the public eye thanks to a January 2013 Sports Illustrated story. In the article, the directors of S.W.A.T.S claimed that various high-profile professional and collegiate athletes were using their products, which included “negatively-charged” water, “concussion caps,” and “holographic performance chips.”
To stay up on the latest science, USADA has an internal research program and is also a partner in the Partnership for Clean Competition (PCC). The PCC was founded in 2008 by USADA along with the United States Olympic Committee, the National Football League, and Major League Baseball.
A working group consisting of five international laboratories developed a liquid chromatographytandem mass spectrometric assay for IGF-1. IGF-1 is comprised of a chain of 70 amino acids in a specific sequence which, using mass spectrometry, can be determined.
The Sports Medicine Research and Testing Laboratory (SMRTL) in Salt Lake City, which was part of the USADA/PCC IGF-1 Working Group, tested the Ultimate Spray and found IGF-1 to have an amino acid sequence consistent of human or cow origin, but could not detect any IGF-1 with the sequence of amino acids from deer. The reason it is not possible to distinguish human IGF-1 from cow IGF-1 is that the sequence of amino acids is identical. Interestingly, no IGF-1 was detected in a Chinese traditional medicine preparation of deer antler velvet, either.
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplements are defined as vitamins, minerals, amino acids, herbs, botanicals, and their extracts and concentrates. The United States Food and Drug Administration (FDA) has taken the position that dietary supplements are also intended to be ingested via the intestinal tract – thus placing sublingual sprays, crèmes, and other drug delivery systems in the category of “new drugs.”
Since deer antlers do not fall within the above definition and a sublingual spray qualifies the product as a “new drug,” S.W.A.T.S was presumably in violation of multiple FDA regulations, although the FDA never sent S.W.A.T.S a warning letter regarding their products. One of the frequently-discussed issues with DSHEA is the lack of funding for enforcement, particularly because companies are not required to register their products with the FDA in advance of their manufacturing.
Due to this inconsistent enforcement, USADA frequently tests supplements for prohibited substances. Ones that have been found to contain prohibited substances, even in trace amounts, are listed on the “USADA High Risk List” on the Supplement411.org website. The site also offers information pertaining to the industry and advice on making wise consumer decisions regarding dietary supplements. USADA also provides the FDA and the Drug Enforcement Agency (DEA) with information regarding its supplement testing results and research.