A recent Natural Products Association (NPA) poll found that 67% of people did not know or were not sure that CBD products being sold today are illegal and 41% wrongly assumed FDA had already developed safety standards for CBD. Despite Americans’ uncertainty, the market for CBD products in the U.S. is surging.
This has been a top priority for NPA this year and we are the only trade association to have secured legislation on the issue. We worked with Congressman McNerney (D-CA) on an amendment that passed the House of Representatives’ Agriculture Appropriations Committee and would appropriate $100,000 for the FDA to perform a Health Hazard Evaluation (HHE) and set a safe level of consumption for CBD. We believe this approach – passing clear legislation that would provide for the FDA to set a safe level – puts consumer safety first.
With the recent class suits against CBD companies and threats to remove these products from store shelves, the trajectory of this marketplace is less clear. We believe the McNerney amendment could uniquely provide a safe harbor for responsible firms that have already entered the CBD marketplace while the FDA conducts the process of setting a safe level.
For these and many other reasons, it is imperative for Congress to direct FDA to immediately begin its oversight and regulation of CBD products. This position on CBD is gaining momentum. For example, the New Jersey State Senate Health, Human Services, and Senior Citizens Committee recently passed a resolution in support of setting a safe level for CBD consumers. NPA has participated in countless meetings at the FDA and other agencies, and our grassroots network has sent thousands of letters to Congress in support of our position on CBD.
2019 also brought challenges and successes in other elements of NPA’s focus in leading the charge to protect the natural products industry’s interests.
Protecting Patent Eligibility
In a landmark decision in March of this year, the U.S. Court of Appeals for the Federal Circuit ruled to protect patent eligibility for natural products. The case sets important precedent for “law of nature exceptions” that otherwise could have invalidated patents for natural products. This one of the biggest issues the industry faces protecting patents for natural products companies will lead to more innovation and more choices for consumers.
Advocacy
With the departure of our longtime friend and champion Senator Orrin Hatch, party change in the House of Representatives and 100+ new Members of Congress, 2019 was all about building relationships. This year at Natural Products Day we demonstrated yet again that we are the strongest advocacy force in the industry.
Bad ideas don’t just happen in Washington, D.C., we’ve had to remain diligent on the state level NPA recently testified in an Oregon Department of Justice hearing to discuss a health claims proposal that would confuse consumers, raise costs for taxpayers and do nothing to protect public health. In February, we defeated a proposal in the Massachusetts State House that would have prevented young people in the Commonwealth of Massachusetts from purchasing products like protein powder and put other popular supplements under lock and key.
Access to Supplements
Americans need more ways to save money in their preventative health care. Yet currently, an outdated administrative change to the tax code prevents people from using their tax-deferred health care dollars for nutritional supplements like calcium or vitamin C. We expect the Internal Revenue Service (IRS) could modernize this section once again to empower consumers. In support of this idea, we worked with U.S. Senators Tim Scott (R-SC) and Kyrsten Sinema (D-AZ), Congressman Buddy Carter (R-GA) and others who last month called on the IRS to designate dietary supplements that carry health or structure/function claims eligible “medical expenses” for HSAs, FSAs and HRAs. This simple change in our regulations would promote the proactive, preventive approach that we need if we wish to improve Americans’ health and healthcare costs.
Regulatory Issues
DSHEA celebrated 25 years this fall and with it comes further speculation on DSHEA 2.0. However, before we push for FDA modernization, it’s my position that the focus should be on what the FDA can already do right now in the interest of consumer safety. Adulterated ingredients that have not completed the required NDI process are entering our country and it has been approximately six years since FDA produced any dietary supplement import alerts to prevent this. FDA’s inaction puts American consumers at risk and compliant U.S. supplement makers at a terrible disadvantage.
Tariffs
NPA has worked with the Trump Administration since September of 2018 to secure an exclusion process. Our natural products grassroots network sent thousand of letters to Congress and it will continue to be important for the industry to engage on this issue.
Promoting Global Benchmarks
We are supporting the work of the Supplement Safety & Compliance Initiative (SSCI) that brings together retailers, manufacturers, suppliers and other stakeholders to recognize and ensure common safety standards throughout the supply chain to enhance consumer safety.
NPA will also support the advancement of food and dietary supplement standards worldwide in an official observer capacity during upcoming Codex Alimentarius Commission meetings. Recognition as a Codex Alimentarius Observer means NPA will contribute its expertise to the development of health standards worldwide.
As we look to 2020, NPA continues to be the largest and oldest nonprofit dedicated to the natural products industry and I expect great things and we continue to work hard in support of our members.
