“We have voluntary guidelines in which we tend to go above and beyond what the federal regulations call for,” said Duffy MacKay, ND, CRN’s senior vice president of scientific and regulatory affairs.
“We use this as a way to say that our members are good citizens,” he told NutraIngredients-USA.
Drawing line in sand on SARMs
The new guideline on SARMs, which can be viewed here, first defines these ingredients.
SARMs, or selective androgen receptor modulators, are steroid like substances that have been showing up in sports nutrition products over the past several years. FDA issued a consumer warning on the products in November of last year. A study published around the same time found that products containing these ingredients were readily available on the market.
In April of this year, Sens. Orrin Hatch (R-UT) and Sheldon Whitehouse (D-RI) introduced a bill to regulate SARMs in much the same way the Designer Anabolic Steroid Control Act (DASCA) did for new forms of steroids showing up on the market. CRN threw its support behind this measure, and it also launched a consumer-facing site to warn about the ingredients’ dangers.
The new voluntary guideline published last month formalizes this stance. “CRN members should not distribute or market dietary supplement products containing SARMs to consumers,” the guideline states.
Concerns about caffeine
Caffeine is a common ingredient with one of the longest histories of use among all dietary ingredients. While the safety of this ingredient has long been established, the safety of some new delivery forms has not.
In April, FDA provided guidance on these new forms of caffeine, which included powdered and liquid forms. In both cases, the safety concern has been that the products are so highly concentrated (the powdered form is essentially pure caffeine), the safe dosages are in such minute amounts that they might not be reliably meted out by consumers using standard kitchen measuring equipment.
While caffeine has been shown to be safe through a wide range of typical dosages, most experts agree these highly concentrated products do present a risk of overdose.
CRN’s caffeine guideline, which can be viewed here, sets out parameters for disclosing caffeine dosages on product labels.
It also states that, “CRN members should not sell or market bulk amounts of pure or highly concentrated caffeine in powder or liquid form directly to consumers.” Such transactions are permitted for CRN members on a business-to-business basis.
“CRN’s membership is committed to consumer safety and understands the gravity of going above and beyond what is required by law to ensure their products are high-quality, consistent, and supported by sound science,” said Steve Mister, president & CEO of CRN.
“Consumer access to bulk amounts of highly-concentrated powder or liquid caffeine and performance enhancing products containing SARMs are current subjects of sharp industry scrutiny. CRN is grateful for FDA’s recent consumer advisories on these ingredients, as well as for guidance providing clarity to companies attempting to navigate the industry’s strict regulatory framework. CRN’s voluntary guidelines align with FDA’s enforcement actions and help the dietary supplement industry stay on the right side of the law.”