Attempts by health advocacy group the Alliance for Natural Health USA (ANH-USA) to drum up ‘grassroots’ support for its campaign against the Food and Drug Administration's (FDA’s) New Dietary Ingredient (NDI) draft guidance have prompted an unprecedented level of activism, the group’s legal director has claimed.
Thousands of consumers and other stakeholders have used templates produced by the ANH-USA to help them write letters to the FDA to express their concerns, while thousands more have called congressional representatives about the controversial document, claimed ANH-USA legal director Gretchen DuBeau.
“In the past three months, 355,000 email messages have been sent by our activists to Congress and the FDA, as well as 20,000 phone calls placed directly to their congressional members. Our grassroots activists … view the FDA’s draft guidance as a barrier to their nutritional supplement access, and we are proud to be working with them to defeat it.”
Meanwhile, the ANH-USA was also directly “lobbying Congress and preparing a legal strategy if one is needed”, said DuBeau.
“By attempting to implement what is essentially a pre-market approval system for supplements, the FDA is overstepping its authority, and is ignoring Congress’s clear intent when the legislation was drafted and voted upon in 1994.”
Emord: NDI guidance is already exerting coercive effect on industry
Speaking to NutraIngredients-USA.com after filing comments about the NDI process on the ANH-USA’s behalf in August, food law attorney Jonathan Emord argued that the guidance had already exerted “a coercive effect on the dietary supplement market [by] causing responsible sellers to believe they must remove products from the market to avoid the risk of being charged with adulteration.”
An assessment conducted for the ANH-USA in July by Emory University professor of law and economics Dr Joanna Shepherd Bailey “revealed the burdens and costs to be extraordinary for the industry, indeed, imperiling it if FDA actually expects the industry to follow its guidance”, argued Emord.