NPA’s comments are in response to President Donald J. Trump’s Executive Order to streamline regulations for American businesses. Comments can be viewedhere.
“The United States has the safest food and drug supply in the world but that doesn’t mean there aren’t areas where we could see some improvement,” said Daniel Fabricant, Ph.D., president and CEO of NPA. “Booming demand for natural products means that a streamlined and efficient regulatory structure is critical in order to protect consumers and public health. We are pleased to work with the Trump Administration to ensure that health conscious American consumers have access to the products they use every day.”
The natural, organic and healthy consumer products sector is predicted to expand with a compound average growth rate of nearly 9 percent over the next two years to $252 billion by 2019, according to theNutrition Business Journal. “Smart, commonsense regulatory reform with a focus on protecting public health will unlock the full potential of our industry and ensure we remain on a level playing field with our overseas competitors,” added Dr. Fabricant.
NPA highlighted a number of regulatory issues (final rules, codified federal regulations, and federal guidance documents) for the Trump Administration to consider, including one that would classify dietary supplements under the same category as pharmaceutical drugs:
- Environmental Protection Agency’s (EPA’s) Reclassification of Dietary Supplements as Pharmaceuticals: Dietary supplements are regulated under the Dietary Supplement Health and Education Act and the Federal Food Drug and Cosmetic Act by the FDA. Under the FDCA, dietary supplements are not classified as pharmaceutical products and therefore should not be included in the definition of hazardous waste pharmaceuticals. By merging two commodities under one definition, the proposed rule would contradict the intent of DSHEA.
- Food and Supplement Labeling – FDA’s Final Rule to Change Nutrition and Supplement Facts: NPA has requested a 3-year delay in the implementation of these final rules to understand whether FDA possess empirical data to support that these changes are necessary and material AND assess their economic impact to small businesses more accurately.
- Regulation of New Dietary Ingredients (NDIs): NPA has been actively involved in working with the FDA on its draft guidance for NDIs. NPA has requested that the FDA consider the economic impact on small businesses as part of their rewrite of NDI guidance.
- Small Business Suppliers of Vinpocetine: The FDA recently took steps to ban a 5-time acknowledged dietary ingredient through issuing an administrative proceeding. The FDA’s actions are causing confusion in the industry and NPA has asked the FDA to clarify that the product is not banned by issuing a notice in the Federal Register.
