Fighting for consumer usage of supplements and best CBD legal pathway

Expanding usage of supplements
Millions of Americans are embracing nutritional supplements to support their health through the pandemic. Yet, we can still do more to safeguard vulnerable populations and provide better health care options.

We believe addressing inequalities starts with addressing nutritional disparities. This is why the Natural Products Association (NPA) recently renewed its effort to expand access to natural supplements through health savings accounts (HSAs), flexible spending accounts (FSAs) and essential social programs like the Supplemental Nutrition Assistance Program (SNAP) and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).

Our effort is gaining traction, with many prominent voices joining our cause. In a recently available column published in Morning Consult, former Congressman and Chairman of the Congressional Black Caucus Ed Towns called on Congress to “consider legislation that modernizes the treatment of dietary supplements,” that ought to include “expanding usage of nutritional vitamin supplements through SNAP, WIC, HSAs and FSAs.”

Policymakers in Washington are also taking note. We expect legislation to be reintroduced by Sen. Kevin Cramer (R-North Dakota) to expand HSAs and FSAs, and Sens. Tim Scott (R-South Carolina) and Marco Rubio (R-Florida) recently introduced legislation to modernize HSAs more broadly. We are grateful because of their leadership, but more lawmakers in Washington need to follow their lead and intensify to the plate.

CBD as a dietary ingredient

For the last several years, the industry’s biggest question has been how and when FDA will establish a regulatory pathway for CBD products. Unfortunately, FDA’s inaction has led to the introduction of misguided legislation in Congress, and a piecemeal state approach from at least 24 states.

One misguided proposal supported by some industry groups-the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act (HR 841)-ignores DSHEA and the brand new dietary ingredient notification process, while doing nothing to make sure we've a science-based regulatory process for consumers. These industry proponents of the bill are peddling misinformation campaigns that marketing of CBD as a dietary supplement cannot be overcome with safety data. They’ve inaccurately argued FDA lacks the authority to create a safe degree of consumption for CBD, claiming that is a simple tenet of DSHEA.

The NDI process specifies data must be provided to FDA on safety of a fresh dietary ingredient 75 days ahead of going to market.

As we have explained all along, FDA should follow the red yeast rice model as a way to achieve a regulatory pathway for CBD. This strategy was proposed by former FDA Commissioner Scott Gottlieb, M.D., through the March 2019 House of Representatives Agriculture Appropriations Hearing. Dr. Gottlieb indicated the most simple path was predicated on intended use, stating, “…one concentration where the product is a drug and another concentration where in fact the product is a food and/or dietary supplement.”

Generally, FDA does this by establishing a level of the ingredient or daily amount via establishing a health hazard evaluation (HHE). Additionally, firms would need to provide safety studies such as a 90-day toxicology study specific with their product and the degrees of CBD contained. These data points would serve as the foundation for FDA to determine an initial level that could allow the agency to take quick enforcement action on products exceeding a daily exposure level that render them unapproved drugs on their face.

This model would permit FDA to strike a balance between consumer usage of CBD-containing supplements and protection of public health by understanding the dose at which an all natural product becomes a drug and, and consequently, produces drug-like unwanted effects. We don't experience such effects in foods or health supplements because of our legal framework, which has given us the safest food and drug supply on earth, and as a result of tenets of science.

It’s hard to imagine some industry leaders would take a position that undermines the entire industry. The proposed bill would harm confidence in FDA’s authority to regulate our nation’s food and drug supply throughout a time when states like California, NY and Massachusetts want to restrict access to supplements and public trust is crucial.

At the state level, NPA continues to work with policymakers from the a lot more than 24 states that are trying to fill the vacuum created by federal regulators. While this approach is in no way the ideal scenario for the industry, if Congress continues to pursue misguided policies, and if FDA won’t lead, the states will continue to offer the best and only alternative.

Supplements face age-restricting state legislation
We are also addressing the radically dangerous proposals in California, New York and Massachusetts that threaten to undermine public health by restricting usage of supplements and that could place costly burdens on smaller businesses hard hit by the pandemic. In addition to limiting usage of popular nutritional supplements throughout a pandemic, the proposals would impose fines on retailers selling protein powder to minors at amounts that are more extreme than penalties for selling alcohol and tobacco to children. These proposals certainly are a distraction from the important roles that supplements like vitamin D play in supporting people’s immune systems. Furthermore, by punishing small local retailers, consumers will be forced to look for supplements online and may even turn to shady fly-by-night companies masquerading as legitimate retailers.

Essential industry
Almost this past year to your day, NPA worked with the federal government to make sure our businesses were declared essential and could actually remain open during the pandemic. This benefitted not only the 3 in 4 Americans who use at least one dietary supplement, but also the personnel who were able to maintain a paycheck during an monetary crisis.

Fast forward a year later, those same employees are actually qualified to receive the COVID-19 vaccine in Phase 1b, ensuring our front-line personnel can continue safely providing millions of Americans with access to products that keep them healthy. From the outset of the pandemic, our businesses did a significant job complying with state, local and federal guidelines to keep their employees and customers safe.