September 20, 2011
FOR IMMEDIATE RELEASE
Contact: James J. Gormley, VP and Senior Policy Advisor, Citizens for Health
Phone: 202.695.2027; email: email@example.com
Washington, D.C. – Citizens for Health (CFH) today launched an action campaign to join with our 100,000 supporters and the rest of the health freedom movement in opposing the FDA’s “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues”. The agency issued the guidance, mandated by the food “safety” law passed earlier this year, in July, purportedly to clarify requirements for filing new dietary ingredient (NDI) submissions.
However, the FDA is going way beyond simply clarifying existing requirements. It is attempting to drastically change existing law by saying that finished product manufacturers must make a submission for every product that contains an NDI or whenever a formula is changed, if an NDI is present.
James Gormley, Vice President and Senior Policy Advisor for CFH, notes:
“Quite simply, the FDA is ignoring Section 413 [21 USC §350b] of the Dietary Supplement Health and Education Act of 1994 (DSHEA), which says an NDI submission is not required if ‘there is a history of use or other evidence of safety’ supporting its inclusion, use and marketing prior to 1994. Essentially, the FDA is making NDI submissions product-specific rather than ingredient-specific, which contravenes the spirit and the letter of DSHEA.”
“In addition, the FDA’s attempt to create new regulatory requirements using a guidance document is in violation of the Administrative Procedure Act (APA), and is in violation of the law on the basis of this alone.”
While much has been written regarding the FDA’s guidance since its introduction, CFH made a strategic decision to “let the dust settle” and do a thorough analysis before adding its voice to the clamor for its withdrawal, given the massive impact to the dietary supplement industry implicit in the guidance. CFH is also calling for the comment period to be extended to July, 2012 so that more industry and policy experts, as well as the public, can be sufficiently heard on the issue. (Industry leaders have succeeded in pressuring the FDA to extend the comment period once already, until December of this year).
In the coming days and weeks CFH will offer further analysis and talking points on the guidance, as well as opportunities to take action. In fact, CFH will be conferring with consumer advocates and health-food industry leaders this Friday at the Natural Products Expo East trade show in a meeting sponsored by Jarrow Formulas, Inc.
CFH asks you to join them, industry leaders, the health freedom community and concerned Americans everywhere in the campaign to get the guidance withdrawn. Furthermore, ask Congress to rebuke the FDA and demand that the agency state, for the record, that they will no longer attempt to deviate from the plain and intended meaning of DSHEA.