Staying in bounds: Part I, sports nutrition regulations

Editor’s note: This is the first installment of a two-part series, Staying in bounds: Policing and penalties in sports nutrition, an excerpt of which appeared in the recent digital magazine Innovation in sports nutrition.

Roundtable overview

If competitive sports can be a game of inches and of winners decided by hundredths of a second or point, why wouldn’t athletes hunt for the slightest of potential advantages, including via dietary supplements? This is indeed the core culture of sports and sports nutrition, from the consumers back through the brands, but with this thirst and game plan comes the high potential for wrongdoing. Many such entrepreneurial risk-takers have found themselves on the wrong side of the law and facing significant fines and jail time, not to mention severe damage to their reputations. It’s “any given Sunday” in the sports nutrition regulatory arena, where sometimes the companies win and sometimes the regulators score a victory.

Natural Products Insider welcomed two longtime sports nutrition industry experts to a roundtable discussion on the regulatory climate in sports nutrition, including what actions and ingredient types tend to hit FDA’s radar and what level of enforcement is appropriate and effective. Rick Collins, Esq., partner at Collins Gann McCloskey & Barry PLLC, and Doug Kalman, PhD, RD, vice president of scientific and regulatory affairs at Nutrasource and co-founder of the International Society for Sports Nutrition (ISSN), offer insights on the finer points of sports nutrition regulation, answering many burning questions about this very active segment of dietary supplements.

In part one, they provide an educational starting point for brands doing business in sports nutrition, especially those new to the segment and/or the dietary supplement industry.

Defining the regulatory field: Boundaries

Insider: Dietary supplements have been a regulated category within U.S. law since Oct. 15, 1994. What are some basics about the Dietary Supplement Health and Education Act of 1994 (DSHEA)?

Kalman: I think it is a good idea that before we start talking about a wide variety of topics of interest and concern within dietary supplements, to give a primer about this category of regulated goods in the United States.

DSHEA defines a dietary supplement, in part, as “a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

(A) a vitamin;

(B) a mineral;

(C) an herb or other botanical;

(D) an amino acid;

(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or

(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E).”

FDA further clarifies on its website, “Dietary supplements are marketed in forms such as tablets, capsules, softgels, gelcaps, powders and liquids.”

Over the years, FDA has flagged many sports supplements containing new dietary ingredients (NDIs). A dietary supplement containing an NDI is considered adulterated under DSHEA unless it meets one of the following requirements:

“(1) The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered.

(2) There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the Secretary (of the U.S. Department of Health and Human Services) with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.”

FDA also looks at an ingredient to determine if the ingredient would meet the statutory definition of a dietary supplement.

FDA does utilize surveillance of the marketplace as one means of determining if ingredients being introduced for sale in the United States are illegal in products marketed as dietary supplements. The agency has posted information here on selected dietary supplement products, ingredients and other substances, such as Acacia rigidula, BMPEA, Cesium Chloride and DMAA.

The above list can help companies stay out of legal peril. We will address this more in depth shortly.

Collins: Adulterated products are those which are unsafe, such as by contamination or mislabeling. Federal law contains two important provisions by which dietary supplements are deemed to be “adulterated.” The first provision, applicable to all dietary supplements, deems a supplement adulterated if it presents “a significant or unreasonable risk of illness or injury under … conditions of use recommended or suggested in labeling, or … if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use.” The second provision addresses only dietary supplements containing “new dietary ingredients” for which FDA believes there may be inadequate information to provide a reasonable assurance that the ingredient does not present a significant risk of illness or injury.

Introducing adulterated supplement products into interstate commerce is a federal crime, regardless of intent. The criminal penalties for a first conviction can include a fine of up to $1,000, imprisonment for up to 1 year, or both. Subsequent convictions, or convictions for offenses committed with the intent to defraud or mislead consumers or FDA, can include fines of up to $10,000, imprisonment of up to 3 years, or both. 

References: 21 U.S.C. §§ 342(f)(1), 350b(a); 21 U.S.C. § 342(f)(1)(A); 21 U.S.C.  §§ 342(f)(1)(B), 350b(a); 21 U.S.C. § 331(a) and (v); 21 U.S.C. § 333(a)(1); 21 U.S.C. § 333(a)(2).

Insider: What are some thoughts on “bad actors” and whether more or less regulation or enforcement of rules on the books would benefit the industry?

Kalman: Great question. It is obvious that FDA and the Department of Justice (DOJ) take action on “bad apples,” and consider it a real issue, as adulterated ingredients may just be a public health concern. Adulterated ingredients, as Pieter Cohen, MD, from Harvard Medical School has written (JAMA Netw Open), “typically involves 1 of 2 patterns: economic adulteration, in which a less expensive ingredient is used in place of a more expensive ingredient listed on the label, or pharmaceutical adulteration, in which an active drug is included in a purportedly botanical supplement, for example, sildenafil in a ‘natural’ sexual enhancement supplement.” 

The public health concern comes from the drug that was purposely or not purposely put into the product labeled as a dietary supplement. So, when a drug—an ingredient with pharmacologic impacts in a human—is put into a product that it is not supposed to be in, consumers may suffer adverse health effects.

Litigation ensues often from the above type of activity, whether from the government (federal or state) or private citizens (civil). Some would say private or government litigation functions as a system of checks and balances for the industry and helps to curtail bad apples or poor players. In reality, there are non-governmental agencies and even trade associations within probably every industry that try to help those in the industry to comply with the regulations for their businesses.

Nonetheless, as the nutrition or dietary supplement industry has a low bar to business entry, the education curve for those new to it, plus those who are not even aware of the rules that regulate the industry, means more bad players will exist.

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 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+% 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 companies who operate in such a manner have to be in the business for a short-term monetary gain and not aware of the regulatory risks. Namely, one is not allowed to use statements or claims that are outside of the dietary supplement definition in DSHEA. This means dietary supplements marketed as having drug-like 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 androgenic anabolic androgenic steroid (AAS). Hence, the implied marketing also is the product would have AAS-like effects for the user. Short story is while these cases would be easy for both FDA and FTC to make against companies, it is low-hanging fruit in the world of protecting consumers. References: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-structurefunction-claims and https://www.ftc.gov/tips-advice/business-center/guidance/dietary-supplements-advertising-guide-industry

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 “it 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 start-up seem to dictate just whom and what services the start-up 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 departments. This is critical for long-term growth.

Insider: How does FDA’s “Dietary Supplement Ingredient Advisory List” factor into this discussion?

Collins: FDA says the advisory list was “intended to quickly alert the public when the FDA identifies ingredients that do not appear to be lawfully included in products marketed as dietary supplements.” So, FDA is telling both businesses and consumers what ingredients they “may wish to avoid,” many of which are sports nutrition ingredients. But FDA also says being included on the list is “based on a preliminary evaluation” and FDA “is taking steps to further evaluate the ingredient.” It’s certainly not a directive. It has no force of law.

Kalman: Are you familiar with any of the following ingredients? If so, these per FDA do not appear to be legal yet are still being sold. Problems may arise for those who sell:

Further, FDA has informed the market and public that the following ingredients do not appear to be legally sold ones:

Finally, FDA recently indicated emphatically that the following two ingredients are not lawfully marketed ingredients and require an NDI notification. However, no company has successfully submitted one yet to FDA. Hence, these are also not compliant ingredients.

Reference: https://www.fda.gov/food/dietary-supplement-products-ingredients/dietary-supplement-ingredient-advisory-list

The information is shared to help companies avoid unnecessary visits, court dates, fines and bad press that can occur when operating outside of the law and regulatory framework of the dietary supplement industry. When companies do not have good internal QA/QC procedures and/or a decent understanding of the state and federal laws that govern their business, there is a very real risk the courts may end up policing companies more than ever wanted.

Insider: Confusingly for some, FDA updated its advisory list to remove higenamine and hordenine. What does that mean?

Collins: FDA says it removed them from the list because it “has determined that the ingredients are new dietary ingredients (NDIs) for which an NDI notification is required and has not yet been submitted.” In other words, it concluded its “steps” to complete its evaluation, finding the ingredient should not be sold without submitting an NDI notification. But some in industry seemed to be initially confused by the way FDA worded its update. “Removing” ingredients from the list made some think FDA was now saying higenamine and hordenine were okay to sell. This kind of confusion continues to be a problem. Some of it may be attributable to marketers “misreading” advisories to their own benefit, but FDA’s notices might be more effective if they were more simply framed and directly worded.

Kalman: To me, this FDA update means the agency is actually digging in, taking a firm stance about questionable ingredients. I think it is a good thing. This gives clear direction to those who wish to develop new and innovative ingredients. It means any product you see on the market that still contains higenamine and or hordenine is a product and brand that is playing with fire—from the governmental regulatory agencies, as well as potentially from the litigious world. I am not so sure that some companies will not use questionable ingredients as part of their marketing. Dangerous place.

Insider: What about warning letters. Are those a better way of advising industry, including new brands?

Collins: Not really because they are so specific to the recipient company. They typically start by listing a bunch of claims made by the company on its website or social media pages that qualify the products as unapproved and misbranded drugs. Then, after all of that, FDA makes a back-up argument that “even if” the products didn’t have the drug claims, they would still be “adulterated” because of a specific ingredient. If you look at the warning letters on higenamine and hordenine, you’ll see what I mean. Basically, a highly specific warning letter to company A may be a great way to advise company A, but it’s not always an effective way of advising the broader industry.

Click here for part 2, Sports Nutrition eforcement trends.