NPA is working directly with regulators to explain the precedent that could be set if this rule were allowed to move forward as written, said Dan Fabricant, PhD, executive director and CEO of NPA. "We think our comments layout a framework whereby vinpocetine fits as a dietary ingredient under the Federal Food, Drug and Cosmetic Act.”
“If this notice goes into effect it will distort the market and confuse manufacturers selling safe and legal products and do nothing to protect consumers,” added Dr. Fabricant. “Because of the far reaching implications this rule could have and the dangerous precedent it would set if allowed to move forward, the FDA should conduct a full economic impact analysis and extend the comment period by a year or withdraw it effective immediately.”
The proposal has also received backlash from senior lawmakers, including Senator Orrin Hatch (R-UT) who recently circulated a letter to the FDA asking the agency to review the impact this proposed rule could have on consumers and manufacturers of dietary supplements.
NPA’s comments can be viewed here.