Mid-term elections and the 114th Congress
Overall the 2014 mid-term elections will likely benefit private industry as Republicans took control of the Senate and strengthened their majority in the House. As with many other industries, Republicans are expected to take a more hands-off approach to the regulated supplement industry.
In addition, the industry bid farewell to lawmakers who significantly influenced the supplement industry. Most significantly, long-time supplement industry advocate Sen. Tom Harkin (D-IA) retired at the end of 2014. Sen. Harkin coauthored the Dietary Supplement Health and Education Act (DSHEA) and served as an ally to the supplement industry for decades. Long-time supplement industry critic Rep. Henry Waxman (D-CA) also retired and his replacement as the lead Democrat on the House Energy and Commerce Committee is Dietary Supplement Caucus Co-Chair Rep. Frank Pallone (D-NJ).
The 2014 elections added to the recent turnover in the House and Senate in recent years and AHPA has been developing relationships with the next generation of supplement allies. Shortly after Sen. Martin Heinrich’s (D-NM) successful election to the U.S. Senate in 2012, AHPA invited him to attend Expo West to introduce him to the herbal and natural products industry. At the end of 2014, Sens. Hatch and Harkin formally recognized Sen. Heinrich as the next Democratic leader in the U.S. Senate for safeguarding access to dietary supplements.
FDA in 2015
The industry will see more of the same from the FDA in terms of implementing, inspecting and enforcing current good manufacturing practice (cGMP) requirements. FDA mandates that companies manufacturing and/or selling dietary supplements must understand and comply with cGMP requirements. Inspections of supplement facilitates will remain a primary focus of the FDA in 2015 and AHPA will continue to dedicate significant resources to develop tools like the AHPA Botanical Identity References Compendium to help the industry meet various cGMP requirements.
The Food Safety Modernization Act (FSMA) is the biggest change to the Food, Drug and Cosmetic Act (FDCA) since it was initially passed in 1938 and the rules implementing FSMA will begin taking effect in 2015 and 2016. These rules will completely change manufacturing requirements for ingredient suppliers and food companies. AHPA has been actively engaged with FDA as it drafts regulatory language to implement FSMA, submitting more than 400 pages of comments recommending improvements to the draft language. AHPA will continue these efforts to improve the regulations and will begin educating members and the industry about FSMA to ensure they understand new requirements and are prepared to comply.
FDA is also expected to finalize guidance for new dietary ingredients (NDIs) in the near future. FDA issued draft guidance in 2011 and is expected to issue a revision before issuing the final guidance. This revised draft is not expected to significantly differ from the draft guidance issued in 2011. There will likely be some changes, but it seems unlikely that FDA’s revisions will ease industry concerns that the guidance reinterprets the legislative language. AHPA will continue to advocate for revisions, but also advise the industry to recognize their responsibility to file NDI notifications if they want to sell NDIs.
There has been growing momentum to ease the prohibition of hemp and cannabis as the many benefits of these plants emerge.
In 2014, the federal government passed the Farm Bill with a provision that allowed agriculture departments and universities to grow hemp in states where it is legal for research purposes. This research will help demonstrate the potential value of producing hemp domestically to avoid reliance on imports from Canada and China. AHPA will continue to advocate for the repeal of restrictions on hemp cultivation so the U.S. can reap the many benefits of this plant.
The budget bill passed in late 2014 included a provision that prohibits the Department of Justice (DOJ) and the Drug Enforcement Administration’s (DEA’s) use of taxpayer funds to interfere in state-sanctioned medical marijuana programs. Federal enforcement actions against state-sanctioned access to cannabis has been inconsistent under the Obama administration, but hopefully this provision will provide some more consistency and more authority for state laws. Several states eased restrictions on medical marijuana use in 2014 and this trend is expected to continue as more states recognize the benefits of medical marijuana and more consumers demand access.
Advocates continue to spend significant resources to promote or fight state initiatives that would mandate labeling products with genetically modified organisms (GMOs), with neither side making much progress. This stalemate is expected to continue in 2015. The only state to pass unrestricted GMO labeling legislation is Vermont and that law is being delayed as it is challenged in the court system.
There also doesn’t appear to be sufficient support in the House or Senate to pass legislation for mandatory labeling products with GMOs. That is why AHPA is promoting a voluntary federal standard for labeling products that don’t have GMOs. This would be based closely on the Organic Food Production Act with a third-party certifying companies that choose to make and label GMO-free products.