The 2019 Dietary Supplements Regulatory Summit took place on May 14th at the Mayflower Hotel in Washington, DC. The event was hosted and led by the leading trade associations in the US vitamin and dietary supplements market, including The Council for Responsible Nutrition, the American Herbal Products Association, the Consumer Healthcare Products Association, the Natural Products Association and the United Natural Products Alliance.
Here’s an overview of the top tips, trends, and updates from the vent.
Dietary Supplement Explosion Creates FDA Regulation Complications
Anyone participating in or analyzing the dietary supplements market over the past two decades agrees that the use and production of dietary supplements have proliferated. At the time of DSHEA’s enactment in 1994, the FDA estimated the dietary supplements market at about $4 billion. Since then, Euromonitor has estimated the market to have grown to USD29.1 billion in 2018. This expansion of the market speaks to how the American public has come to interact with these products as well as how its magnitude was not accounted for DSHEA’s original scope.
As a consequence of DSHEA’s reactive enforcement approach, dietary supplement regulation has been underwhelming in many industry participants’ eyes. With a limited budget and staff, the FDA lacks the necessary resources to fully achieve its full goals of regulating the industry according to its three principles: promoting consumer safety, ensuring product integrity, and fostering informed decisions. While much of the market properly obey the FDA’s guidelines, bad players making unsubstantiated claims or mislabeling supplement ingredients are opening the American public to potential danger in often trusted products.
The April release of the Dietary Supplement Ingredient Advisory List has been a notable highlight in recent FDA action. Acknowledging its own limited resources, the Advisory List is an additional tool for the FDA to educate consumers on ingredients that are not safe to consume. As consumers continue to use the internet as a means to self-educate, the presence of a verified warning list will likely deter some misinformed purchases.
New Institution Testing of Botanical Dietary Supplements
Similar to other personal care categories, the demand for naturally-positioned dietary supplements has increased in the US. Euromonitor estimates a CAGR of 5.1% from 2013-2018 for US sales of Herbal/Traditional Dietary Supplements, reaching USD4.3 billion in 2018. Due to the complex nature of sourcing and refining naturally-sourced ingredients, the herbal/traditional dietary supplements market is rife with bad practices such as ingredient and dosage mislabeling. Cynthia Rider of the newly formed public-private partnership of industry, academia, and government, called the Botanical Safety Consortium (BSC), presented on the progress of the group’s focus for “advancing the science of botanical safety evaluation”. In a recent analysis of gingko biloba supplement samples from store shelves, BSC showed a variety of cases of adulteration. With a greater focus on botanical supplements, ideally, the FDA will be able to pursue penalties for such cases of malpractice.
CBD Regulation Complications
Among the topics of conversation at the Dietary Supplements Regulatory Summit, the regulation of CBD, or cannabidiol, products were amongst the most controversial. Given the exponential increase in interest for CBD by American consumers, dietary supplement players are keen on capitalizing on the apparent demand. However, under FDA definitions, CBD is not compliant as either a food or dietary supplement. Despite a contradicting statement by ex-commissioner Scott Gottlieb in April, Steven Tave, Director at the Office of Dietary Supplements, clarified that his agency did not have enforcement discretion for CBD. Enforcement discretion by the FDA, in the case of CBD, could materialize in the FDA providing a written framework on proper CBD manufacturing and advertising policies or guidance to the public on proper use. While the FDA will continue to focus on using its available resources to penalize CBD companies posing higher risks to the American public, the agency is still far from allowing CBD to be integrated in food products or dietary supplements despite rampant production and use.
FDA-Industry Conflicts for Weight vs. CFU in Probiotics
In a discussion panel between Robert Durkin of the Office of Dietary Supplement Programs and Paul Bolar, VP of Regulatory Affairs at Pharmavite, the two discussed where the agency’s and industry’s standpoints are on probiotic labelling. While the FDA is hesitant to amend its labelling requirements for microbial ingredients, the proper measurement for probiotics is widely thought not to be weight. Instead, Bolar and industry players would much rather use CFUs (colony forming units), despite its own flaws as a measurement, as it represents microbial availability in probiotic products. By ideally depicting the CFU count in probiotics at the end of their shelf life, consumers could better gauge the efficacy of the products they are purchasing. In displaying CFU at the end of shelf life, consumers could avoid purchasing expired probiotics that will offer diminished benefit. However, Durkin’s stance was stern in stating the FDA would need further research and findings to amend its position.