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Marketing and manufacturing sports nutrition products, legally

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Regulatory and legal compliance issues can be common among sports brands, as many of the latest hot ingredients and products run afoul or play in the gray areas of DSHEA.

The sports nutrition segment has always been rife with innovation drive, as the quest for a competitive edge is steadfast from athletes back through brands and their suppliers. This hunger, however, can lead to regulatory and legal compliance issues, as many of the latest hot ingredients and products run afoul or play in the gray areas of DSHEA (the Dietary Supplement Health and Education Act of 1994).

Natural Products Insider talked extensively about regulation and enforcement with sports nutrition experts Rick Collins, Esq., partner at Collins Gann McCloskey & Barry PLLC, and Doug Kalman, Ph.D., RD, co-founder of the International Society for Sports Nutrition (ISSN) and SVP of scientific and regulatory affairs at the Natural Products Association (NPA)—Kalman was vice president of scientific and regulatory affairs at Nutrasource at the time of the interview.

Insider: Do you think the mindset of marketers in sports nutrition is different from other natural product categories?

Collins: I do, because the mindset of the consumers was different back in the day. The category was traditionally less about “health” and more about “bigger, faster, stronger, leaner.” I remember years ago there was a successful brand whose product names were exclusively the trade names of anabolic steroid drugs even though none of the products actually contained any anabolic steroids. While today’s consumers may be more sophisticated and varied, with Pilates moms and weekend warrior dads, the hardcore roots still show. Endorsers are often physique athletes with bodies unattainable by 95-plus% of consumers. Some of the company owners are themselves former competitive athletes who have a higher tolerance for edgier ingredients. It’s just different from the granola folks selling herbs or vitamins.

Kalman: Ah, yes Rick, I do recall a line of “hardcore” sports nutrition products that all had the exact steroid names and the product name, or a name that was just one letter off from being the actual named drug. I thought at the time that the companies who operate in such a manner have to be in the business for a short-term monetary gain and not aware of the risks that they play with. Namely, one is not allowed to use statements or claims that are outside of the dietary supplement definition in DSHEA. This means that dietary supplements positioned to, marketed as having druglike effects, or even being a drug is inconsistent with FDA and FTC laws. So, a wrongly named supplement of “Winstral” is considered a drug and a drug claim, because the implied claim from the product name is “Winstrol,” an anabolic androgenic steroid (AAS). Hence, the implied marketing also is that the product would have AAS-like effects for the user. Short story is that while these cases would be easy for both the FDA and FTC to make against companies, it is low-hanging fruit in the world of protecting consumers.

Insider: How much due diligence is done by new sports nutrition companies before launching a product?

Collins: Too often, not enough. Some either conduct no due diligence into the legal status of the ingredients they sell or into marketing restrictions. Or they just ignore sound legal advice. Literally this morning I was contacted by a guy marketing selective androgen receptor modulators (SARMs) on his website seeking to connect with me on social media. SARMs are illegal to sell as dietary ingredients. I offered a friendly admonition that he should carefully investigate the legal status of his business practices and product line, and he seemed genuinely shocked to hear there was any problem at all.

Kalman: For me, the answer to this question really is “depends” because, in my experience, the knowledge, experience and past history of the individual or group entering the dietary supplement business really drives awareness of how to access and follow the rules of the regulated category. Also, the economics of a startup seem to dictate just who and what services the startup will employ. Best bet? If you are planning to do business in a regulated market, try to learn about all the different state and federal rules that apply to your product(s) and industry, while hiring full-time or as a consultant, someone who can drive your regulatory and quality control [QC] departments. This is critical for long-term growth.

The “Cutting-edge change in sports nutrition innovation” digital magazine contains the full version of this article. Click the link to read it, along with related content in the category.

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