Incoming Trump Administration and Republican Congress
The presidential election came as a surprise to many. The impact of the incoming Trump administration’s on the herbal products industry remains to be seen, but Trump’s anti-regulatory stance will likely provide new opportunities and challenges. It will be important for the industry to stay actively engaged with the incoming administration to identify and take advantage of new opportunities and quickly address any emerging challenges.
President-elect Trump’s campaign rhetoric strongly suggests his preference for small federal government which could mean less federal regulatory pressure on business and industry as a whole. This impulse could be reinforced by the Republican-controlled Congress. The Republican-controlled House and Senate may also create a favorable climate for fending off anti-supplement policy efforts by the industry’s few congressional detractors. The Trump administration and Republican Congress aversion to federal regulatory intervention could present opportunities to enact improvements to the existing dietary supplement regulatory framework in 2017.
The dietary supplement industry’s self-regulatory initiatives may also take on even greater importance if president-elect Trump and Republicans weaken federal regulations. All of this indicates the need for continued vigilance and engagement by the industry.
FDA Guidance for New Dietary Ingredients
FDA issued revised draft guidance for new dietary ingredient (NDI) requirements in 2016 and the agency could finalize the guidance in 2017. AHPA submitted comments that urge the FDA to revise this guidance in order to more effectively accomplish the agency’s stated goals.
AHPA has communicated to FDA that the latest version of this guidance is unlikely to achieve the agency’s stated goals of improving the rate of compliance with the NDI notification requirement and the quality of notifications. AHPA has also expressed concern that the 2016 revision of draft guidance is contrary to the intent of the law in numerous areas and would unnecessarily burden the industry.
Despite the fact that FDA’s guidance needs improvement, responsible companies can still navigate NDI requirements successfully—as several AHPA members have done—in order to continue to meet consumer demand for innovative products. However, AHPA will continue to advocate for guidance that both meets the intent of the law and accomplishes the supplement industry and FDA’s shared goals.
Efforts to ban ingredients currently in the market
The Drug Enforcement Agency proposal to use its authority essentially ban kratom almost immediately in 2016 was met by a well-organized response by kratom supporters. This resulted in the DEA delaying the ban to do a more thorough review of the plant. DEA has been collecting information in 2016 to inform decisions about the plant that could come in 2017. AHPA has expressed concern about the DEA using its scheduling authority to essentially ban a plant that is currently in the market because naturally occurring constituents of the plant are scheduled under the Controlled Substances Act (CSA).
AHPA also urged DEA to refrain from taking any action that would limit research in to the benefits and risks of botanicals. Restricting research is a disservice to consumers, especially those who may benefit from using the plant.
In 2016, FDA tentatively concluded that vinpocetine (another ingredient currently in the market) is excluded under Dietary Supplement Health and Education Act (DSHEA) from the definition of a dietary supplement. AHPA submitted comments recommending the Secretary of Health and Human Services (HHS) consider initiating rulemaking to declare vinpocetine to be lawful dietary ingredient. In addition, AHPA encouraged FDA to clarify that if vinpocetine is either found to be currently in the market as a food ingredient or comes to be included as a food ingredient in the future, the ingredient would therefore qualify as a dietary ingredient.
Hemp and Cannabis
State acceptance of cannabis for medical purposes and adult-use continued to expand in 2016 and there is no indication that this trend will slow in 2017. For the most part, the Obama administration did not intervene in state efforts to legalize cannabis. It remains to be seen how the incoming Trump administration will handle the growing number of states adopting laws that contradict federal drug policy for cannabis.
Hemp seed oil has been established in the market for decades and there appears to be no risk of it being removed. Congressional support for other hemp-derived products was clearly demonstrated in Section 7606 of The Farm Bill which was signed into law in February 2014. That section authorized research on hemp to determine whether commercial production would benefit American farmers and businesses.