Citing the scope of the draft guidance, its complexity, and its potential impact, a letter on behalf of Jarrow Formulas Inc (JFI) said that the 90-day comment period is insufficient, and that it is “respectfully requesting” an extension to July 5, 2012.
The call follows an initial request on July 26, 2011 by law firm Hyman, Phelps & McNamara, P.C. to extend the comment period to one year.
According to JFI, the NDI draft guidance is “far more complex” than the proposed rule for dietary supplement good manufacturing practices (GMP) and in this case FDA did grant an extension of the comment period to a full year.
“As detailed below, the NDI Guidance, if anything, would have an even greater impact on the supplement industry and the American people,” states JFI.
“The trade, all stakeholders, and the public must have a reasonable time to answer.”
The letter, signed by attorneys P. Scott Polisky from and Susan Brienza from Ryley Carlock & Applewhite, goes on to note that the draft guidance is “fundamentally at odds with existing NDI regulation”, and “seeks to contravene the law, in particular, Section 4 and Section 8 of the Dietary Supplement Health and Education Act (DSHEA)”.
As reported by NutraIngredients-USA, the press secretary of Senator Orrin Hatch (R-Utah) noted that DSHEA co-author was “alarmed by the guidance. He does not believe it is consistent with DSHEA”.
“We need more time for legal analysis,” says the letter.
Costs of compliance
The letter also cites a “failure” of the Draft Guidance document to consider the “staggering cost of compliance” and said that more time is needed to analyze this issue.
A number of other reasons are cited in the five-page letter.
Request from the trade associations
JFI are not the only organization to request an extension: In addition to the July 26 request from Hyman, Phelps & McNamara, the dietary supplement industry trade associations joined together to call for a 45-day extension to the 90-day public comment period on August 3.
Th five associations involved include the Council for Responsible Nutrition (CRN), United Natural Products Association (NPA), American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA) and the Natural Products Association (NPA).