Government

Assessing the Legal, Regulatory Issues in Sports Nutrition

Brand owners looking to jump into the sports nutrition category need to exercise care and thorough due diligence; bad choices on ingredients, labels or claims can be disastrous, as this category is being subjected to higher levels of scrutiny than most other segments of the industry.

According to 2014 research from Persistence Market Research, the global sports nutrition category of the dietary supplement market was valued at US$20.7 billion in 2012 and is expected to grow to an estimated value of $37.7 billion in 2019. The profit potential is huge. However, brand owners looking to jump into this burgeoning category need to exercise care and thorough due diligence. Bad choices in ingredients, labels or claims can be disastrous, as this category is being subjected to higher levels of scrutiny than most other segments of the industry.

Only occasional regulatory enforcement efforts were conducted in the earlier history of the category. In 2004, FDA published final rules declaring supplements containing ephedrine alkaloids and those containing androstenedione are considered adulterated, and therefore, they are illegal products. But the enhanced scrutiny really started in 2009, when federal agents executed a search warrant on the headquarters of Bodybuilding.com, a popular online sports nutrition distributor. The affidavit in support of the warrant alleged that the company, through its website, was illegally selling anabolic steroids purported to be dietary supplement products. As recently as summer 2015, sports nutrition products containing illegal steroids have continued to be in the crosshairs of FDA and DEA investigators. While dehydroepiandrosterone (DHEA) is a legal steroidal ingredient by act of Congress, a new 2014 law renders the vast bulk of so-called “prohormone" products illegal under the Controlled Substances Act—making not only the seller but also the buyer subject to criminal prosecution. Those steroidal ingredients that do not fall under the new law may, nevertheless, be illegal under existing provisions of the Food, Drug and Cosmetics Act.

Muscle-building products are not the only sports nutrition products subject to scrutiny. Energy and weight-loss products are also on FDA’s radar. An example is DMAA (1,3-dimethylamylamine), initially marketed as “geranium extract" and described as a natural stimulant derived from geranium. In 2012, FDA issued two warning letters over DMAA contained in a popular sports nutrition product. The following year, FDA, the Centers for Disease Control and Prevention (CDC) and state health authorities began investigating the link between the product and cases of acute non-viral hepatitis and liver failure in Hawaii. Under pressure, the maker of the product ultimately conducted a recall and destroyed the remaining stock, worth $22 million.

Searching for alternatives to problematic stimulant ingredients can lead to further problems. In April 2015, FDA sent warning letters to 14 companies over DMBA, an ingredient which is a close analogue to DMAA, and to five companies over BMPEA, an ingredient that is an analogue to amphetamine. The DMBA and BMPEA warning letters mirror the DMAA warning letters, alleging that even if they are dietary ingredients, they are new dietary ingredients (NDIs)  requiring a notification to FDA. Further, even if a notification were to be filed, FDA knows of no evidence of safety, and because both ingredients are often produced synthetically, they are not “dietary ingredients" that may be used in supplements.

The sports nutrition category constantly seeks innovative new product types. One of the latest is a group called Selective Androgen Receptor Modulators (SARMs), which may help speed up the muscle-building process. While not steroids, these are synthetic drugs, sometimes even having been the subject of clinical research by pharmaceutical companies. Looking at whether these compounds fit the definition of a dietary supplement as set forth in Title 21 of the US Code § 3211(ff) provides a great opportunity to discuss the requirements of the Dietary Supplement Health and Education Act (DSHEA) and their impact on choice of ingredients in this category.

The importance of truthful labeling in this category is also paramount. Plaintiff’s class action lawyers have been targeting sports nutrition in recent years, heaping serious trouble on companies that fail to exercise due care. For example, recent lawsuits have focused on so-called “protein spiking" in muscle-building protein products. Companies that added amino acids and other less expensive non-protein ingredients to increase the overall nitrogen content of their protein powder have been hit with lawsuits alleging this spiking, which fools the nutrient content test into thinking there is a higher concentration of protein, and also fools consumers who are paying for protein they aren’t getting.

Further, the claims that a sports nutrition company may make about its products can turn what would otherwise be a lawful dietary supplement product into a drug under the law. For instance, in 2014, FDA sent a warning letter to a dietary supplement maker stating that the claims made about certain products rendered the products unapproved new drugs. The claims at issue, “[R]aise total and free testosterone levels" and “[H]elps blood sugar stabilization, boosting libido," can be found on any number of sports nutrition supplements. But whether right or wrong, FDA can take the position that such claims are “disease claims" that alter the regulatory status of the product—creating regulatory issues and potentially inviting class action lawsuits.

Rick Collins, Esq., is a lawyer dedicated to the health and fitness community. His law firm represents numerous companies in the sports nutrition industry as well as amateur and professional athletes. He is internationally recognized as a legal authority in the field of dietary supplements and performance-enhancing substances. He has served as legal counsel to the International Society of Sports Nutrition (ISSN) since its formation, and is also the official legal advisor to the International Federation of BodyBuilders. He has contributed chapters to two textbooks on sports nutrition, is a frequent contributor to various health and fitness publications, and writes a monthly column for the nationally circulated Muscular Development magazine. Collins is a nationally Certified Strength and Conditioning Specialist (NSCA-CSCS) and former personal trainer and competitive bodybuilder.

Looking for more information on the Sports Nutrition Market?

Rick Collins will speak on legal and regulatory issues in the market as part of the Sports Nutrition Workshop at SupplySide West. The three-hour workshop will take place on Friday, Oct. 9, at Mandalay Bay in Las Vegas. Visit http://west.supplysideshow.com/workshops.aspx for the complete agenda and to get registered.

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