In 2022, we continue to engage on issues with the Biden administration and Congress, awaiting court rulings that have broad impacts on the natural products industry, and struggling 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 look at how we predict some of these issues will play out in 2022.
Hold the FDA accountable to consumers and businesses
As we said before, the most important issue facing the natural products industry 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 asked Dr. Califf how he would use the authority of the FDA to deal with issues like falsified products that violate the New Dietary Ingredient Notification (NDI) process and regulate the CBD market. Our other priorities for the next Commissioner include protecting the intellectual property rights of stakeholders and achieving meaningful transparency on the Agency’s activities, or lack thereof, related to cGMP inspections, notifications of structure allegations. -function and notifications of new food ingredients.
Achieve industry consensus to hold the FDA accountable for its position on food ingredients such as NAC
While we remain concerned about the FDA’s inaction in several areas, we are also concerned about the agency’s over-reliance on food ingredients such as N-acetyl-L-cysteine (NAC). The NPA filed a lawsuit in December last year challenging the FDA’s misapplication of the DSHEA’s “exclusion clause” regarding the dietary ingredient NAC. The NPA calls on industry and industry trade groups to join our legal action and present a united front against the dangerous precedent that the FDA’s illegal actions have set. We strongly believe that this is not just an NPA issue, but that it is impacting the entire industry. We look forward to working with the industry pending the outcome of our legal action, and will continue to explore all possible legal options.
Address the list of mandatory products at Congress
As the FDA is taking no action to enforce the laws it already has in place, some members of Congress continue to call for the agency to have more authority in the form of a mandatory product list. We continue to believe that the Mandatory Product List is a “solution to the search for a problem”. We have long stated that we support the FDA’s implementation of the regulations set out in the DSHEA. However, we need to see the FDA fully implement the DSHEA before providing them with additional authority. For example, it recently emerged that the FDA inspected fewer facilities in 2021 than it did in 2020 – the height of COVID. Not to mention that the FDA already has databases on the ingredients and labels of dietary supplements. The FDA hasn’t used the existing information it already has, so why expect anything different from a mandatory product list? We expect mandatory product listing legislation to be reviewed in the coming year and we are ready to involve Congress throughout the process.
Respond to the fallout from the pandemic Have
The COVID-19 pandemic and the government’s response to it continue to challenge the way we do business and meet the growing demand for the products we make. One of the biggest challenges this year could be determined by how the Supreme Court rules on the Biden administration’s rule on vaccines and testing. A decision to keep the rule in place could lead to a mass exodus of workers from companies already facing a labor shortage. NPA filed a petition with the Sixth Circuit Court of Appeal. The matter is now before the Supreme Court for decision.
Dealing with the supply chain crisis Have
In a recent NPA survey, our members reported significant delays in receiving orders, price increases, and a growing inability to obtain product. Plastic products, including bottle caps, bottles, packaging supplies, and raw and finished products, are some of the items that businesses struggle to source. To reduce the pressure, companies have said they are rationing products, researching alternatives, opening new lines of credit, buying items they don’t usually carry to fill store shelves, and buying items ahead of time.
Engage policymakers during an election year
The politics of the election year still determine decision-making in Washington and state capitals, and this year’s midterms will be no different. Along with the interim terms of Congress, 36 governor seats, 30 attorney general seats, and 88 of the state’s 99 legislative chambers will hold regular elections. The industry will have the opportunity to engage candidates during the process and to support those who we believe will support the industry and the millions of consumers who use our products every day.
State blocking of proposals to restrict access to supplements Have
Although most state legislatures have been closed to the public due to COVID-19, the NPA has conducted an aggressive state lobbying campaign, mobilized its base, and testified before legislative committees to reject these proposals. More than 10,000 NPA members and dietary supplement supporters have written to their respective representatives urging them to oppose the proposals. The NPA is also sounding the alarm bells in Washington, DC, and with our fellow trade associations about how these state-level proposals may impact political decisions in Washington. We expect these proposals to reappear alongside similar proposals in New York, New Jersey, Missouri, and possibly Illinois, and will continue to confront them with the same aggressive approach.