In a letter sent to President-Elect Trump this week, NPA details top priorities for the supplement industry, including maternal and child nutrition, regulating NDIs, enforcing against kratom products, and more.
Photograph by Michael Vadon/Wikimedia Commons/CC-BY-SA-4.0.
In a letter sent earlier this week, the Natural Products Association (NPA; Washington, DC) congratulated President-Elect Donald Trump on his election victory and detailed some of the issues it sees as top priorities for the dietary supplement industry under his administration. Those goals include focusing on maternal and child nutrition, enforcing against kratom products, reducing the cost of healthcare, and more.
The letter, dated January 10 and authored by Dan Fabricant, PhD, CEO and executive director of NPA, lists the regulation of new dietary ingredients (NDIs) as one its first industry priorities. NPA urges the Trump administration to ensure that FDA considers industry comments on the recently released NDI draft guidance. Fabricant says he hopes FDA will take its time to get the guidance right and not “rush to finalize, which would only serve to enable plaintiff attorneys to use the current version and its inaccuracies as a binding norm to tax a growing industry.”
Fabricant cautions that “the current draft guidance could actually result in more bad actors skirting the law entirely, which is the opposite of what a sensible regulatory regime should be. The FDA must also consider the economic burden on small businesses that could create a chilling effect on innovation, and lead to fewer submissions from legitimate firms.”
Kratom, an area where NPA has taken a hardline approach in recent months, also appears as a key priority in NPA’s letter to the president elect. Given Trump’s past focus on the opioid epidemic, NPA hopes the incoming administration will work to enforce against kratom products and raw kratom botanical ingredients, as NPA believes they represent a threat to public health along the same lines as the opioid epidemic.
Additionally, Fabricant proposes that one way to reduce healthcare costs in coming years could be to have government-subsidized medical centers replace 10% of certain pharmaceutical drugs with dietary supplements. For instance, replacing pharmaceutical omega-3s or niacin with omega-3s or niacin from supplements could save taxpayers tens of millions of dollars per years, Fabricant suggests. NPA also urges the incoming administration to expand access to nutritional supplements through the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
The letter continues by asking the Trump administration to help develop a clear definition for medical foods-an issue that the recent draft guidance suggests FDA offers “no recognition in the context of foods assisting individuals in managing nutritional needs associated with disease,” Fabricant explains.
“Our goal should be to establish a clear path to market, utilizing the current state of nutritional science to benefit the health of all Americans while potentially reducing overall healthcare expenditures,” Fabricant writes.
Finally, Fabricant also called for a review of the health claims process, as only 22 qualified health claims are currently allowed by FDA, while the European Food Safety Authority (EFSA) has approved more than 200 health claims.
Read more:
Dietary Supplement Contract Manufacturing in a Time of Trump
“New Congress Means New Opportunities,” NPA Says
New NPA Database Is “More than Just Warning Letters”
Michael Crane
Associate Editor
Nutritional Outlook Magazine
michael.crane@ubm.com
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