Industry has been calling for FDA to create guidelines for filing new dietary ingredient notifications (NDINs) almost since the day after the Dietary Supplement Health and Education Act of 1994 (DSHEA) passed. The law mandated FDA notification for any new dietary ingredient (NDI) that enters the U.S. market after Oct. 15, 1994, the day DSHEA became law. As with other guidance documents, the NDI guidance will ultimately serve to describe FDA's current thinking on the matter, not to amend current law.
When FDA issued its "Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues" on July 1, 2011, 17 years after DSHEA passed, industry was quick to commend the agency for complying with FDA's Food Safety Modernization Act (FSMA). That act mandated FDA release an NDI Draft Guidance by within 180 days; FSMA was enacted Jan. 4, 2011.
As the comment period came to a close on Dec. 2, 2011--a 60 day extension from the original September deadline--it was clear industry praise had stopped. It's a good thing the document is only a draft because most say it is unworkable and illegal. Comments submitted by industry trade organizations, nonprofits, companies and lawyers all pointed to major flaws in the Draft Guidance. The overwhelming conclusion was that the Draft Guidance, as written, is not in line with DSHEA or FDA enforcement history. Most came to the conclusion that the Draft Guidance needs to be rewritten and reissued.
"We at NPA and the industry as a whole would like clarity from FDA on the NDI process," said John Gay, executive director and CEO, the Natural Products Association (NPA). "We did call upon and support the call for FDA to produce a guidance, but not this guidance. We as an industry need a guidance that is DHSEA compliant, and we will work with FDA to accomplish that goal."
The major industry organizations—American Herbal Products Association (AHPA), Silver Spring, MD; the Council for Responsible Nutrition (CRN), Washington; the Consumer Healthcare Products Association (CHPA), Washington; NPA, Washington; and the United Natural Products Alliance (UNPA), Salt Lake City—called for FDA to withdraw the NDI Draft Guidance and issue a new guidance that it is consistent with the DSHEA, in comments filed separately. And they weren't the only ones.
In fact, Citizens for Health (CFH), Washington, collected 12,686 signatures in 10 days from industry members and consumers calling for Congress to withhold FDA appropriations until the agency withdraws the Draft Guidance. CFH representatives delivered the petition to the House, the Senate, FDA and President Obama on Dec. 2, 2011. CFH also submitted comments calling for FDA to withdraw the Draft Guidance.
In joint comments filed to the docket, CRN and CHPA said the Draft Guidance redefines the NDI notification process, contradicts the spirit of DSHEA and conflicts with nearly two decades of agency practice and policy. "It would impose significant and unnecessary new burdens on the dietary supplement industry without conferring safety benefits to consumers," the two trade groups said in the comments.
