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.
Addressing mandatory product listing in Congress
As FDA fails to take action to enforce the laws it already has on the books, some Members of Congress continue to call for the agency to have more authority in the form of a mandatory product listing. We continue to believe that mandatory product listing is a “solution in search of a problem.” We have long stated we support FDA fully implementing the regulations delineated in DSHEA. However, we need to see FDA fully enforce DSHEA before providing them with any additional authority. For instance, it recently came to light that FDA inspected fewer facilities in 2021 than they did during 2020 – the height of COVID. Not to mention FDA already has dietary supplement ingredient and label databases. FDA has failed to utilize existing information they already possess so why would anyone expect anything different from a mandatory product list? We expect mandatory product listing legislation to be considered in the year ahead, and we are prepared to engage congress throughout the process.
Responding to the fallout of the pandemic
The COVID-19 pandemic and the government’s response to it continue to challenge the way we do business and meet the increased demand for the products we produce. One of the biggest challenges this year could be determined by how the Supreme Court rules on the Biden Administration’s vaccine and testing rule. A decision to keep the rule in place could result in a mass exodus of workers from businesses already facing a labor shortage. NPA filed a petition asking the Court of Appeals for the Sixth Circuit. The issue is now before the Supreme Court for decision.
Addressing the supply chain crisis
In a recent NPA survey, our members reported significant delays in receiving orders, incurring price increases, and an ever-increasing inability to get products. Plastic products, including bottle caps, bottles, packaging supplies, and raw and finished products, are among items businesses are having difficulty obtaining. To reduce the strain, businesses reported rationing products, looking for alternatives, opening new lines of credit, purchasing items they do not usually carry to fill store shelves, and purchasing items in advance.
Engaging policymakers in an election year
Election year politics always drives decision-making in Washington and state capitals, and this year’s mid-terms will be no different. Alongside the congressional midterms, 36 gubernatorial seats, 30 attorney general seats, and 88 of the 99 state legislative chambers will hold regularly scheduled elections. The industry will have an opportunity to engage candidates during the process and support those we believe will support the industry and the millions of consumers who use our products every day.
Blocking proposals at the state level to restrict access to supplements
Despite most state legislatures being closed to the public because of COVID-19, NPA waged an aggressive state lobbying campaign, mobilized its grassroots, and testified before legislative committees to defeat these proposals. Over 10,000 NPA members and dietary supplement supporters wrote their respective state representatives urging them to oppose these proposals. NPA is also sounding the alarm in Washington, DC, and with our fellow trade associations about how these proposals at the state level can impact policy decisions in Washington. We expect these proposals to remerge alongside similar proposals in New York, New Jersey, Missouri, and possibly Illinois, and will continue to confront them with the same aggressive approach.