In 2022 we continue engaging on issues with the Biden Administration and Congress, awaiting decisions from the courts that have wide-ranging impacts on the natural products industry, and fighting at the state level to block proposals that would restrict access to popular natural products. One thing is clear: we are facing challenges from all sides. Here’s a quick look at how we expect some of these issues to play out in 2022.
Holding the FDA accountable for consumers and businesses
As we have said before, the single most important issue the natural products industry faces right now is ensuring that we have consistent enforcement policies from the Food and Drug Administration (FDA). The Senate is likely to confirm Robert Califf, MD to serve as the Agency’s next commissioner. We have asked Dr. Califf about how he will use the FDA’s authority to address such issues as adulterated products that violate the New Dietary Ingredient (NDI) notification process and regulate the CBD marketplace. Our other priorities for the next commissioner include protecting stakeholder’s intellectual property rights and achieving meaningful transparency on the Agency’s activities, or lack thereof, related to cGMP inspections, structure-function claim notifications, and new dietary ingredient notifications.
Reaching industry consensus on holding FDA accountable for its position on dietary ingredients such as NAC
While we remain concerned about the FDA’s inaction in several areas, we are equally worried about the agency’s overreach on dietary ingredients such as N-acetyl-L-cysteine (NAC). NPA filed a lawsuit in December of last year challenging FDA’s wrongful application of the “exclusionary clause” of DSHEA regarding the dietary ingredient NAC. NPA is asking the industry and industry trade groups to join our lawsuit and present a united front against the dangerous precedent FDA’s unlawful actions have set. We firmly believe that this is not just an NPA issue, but one that impacts the entire industry. We look forward to working with the industry as we await the outcome of our lawsuit, and we will continue to review all possible legal options.