The letter was written by Leon Bruner, PhD, chief science officer for the Grocery Manufacturers Association, joined by 20 other industry trade associations, including the American Herbal Products Association. The combined group, Bruner wrote, is asking for: “The prompt release of the Food and Drug Administration’s (FDA’s) Guidance for Industry regarding the food facility registration renewal process. Expeditious release of this guidance is necessary for the food industry to meet the statutory obligation to re-register with FDA starting on October 1, 2012.”
Procedure is as yet unclear
Food production facilities have already been required to register under the 2003 bioterrorism law. FSMA changed this one-time requirement to an every-other-year obligation, and this year is the first. Companies have until the end of the year to comply with the requirement. Without firm guidance from FDA, Bruner wrote, companies might submit inappropriate or incomplete information.
“Industry needs guidance to understand both the logistical and substantive requirements for re-registration. It would be extremely inefficient and costly for companies to re-register shortly after October 1st based on the old procedures, only to find out later they have to do it all over again after FDA clarifies the new procedures in its new guidance. Thus, it will be difficult, if not impossible, for food facilities to effectively and efficiently meet FSMA’s registration renewal mandate without guidance from FDA,” he wrote.
Michael McGuffin, executive director of AHPA and his staff have worked in recent months to educate their members on FSMA. Many AHPA members are smaller firms that lack the manpower to devote chunks of time trying to understand the latest nuances of recent additions to federal laws. And AHPA has characterized FSMA as one of biggest changes to dietary supplement regulation since DSHEA. As for the re-registration imbroglio, McGuffin said the sticking point was the uncertainty.
“Will it be considerably more complicated? I don’t believe it will. The concern isn’t about complexity. We want the instructions to be crystal clear on Monday and we want them not to change,” McGuffin said.
The registration requirement applies to any food production facility that intends to sell its products in the U.S., regardless of location. Lack of guidance, Bruner wrote, could affect “hundreds of thousands of facilities worldwide.”
Confusion over food categories
Tied up with the issue of the new filing requirements is an issue that AHPA communicated with FDA about previously, namely the addition of new categories under which a food or supplement product might fall. In a draft guidance on the subject filed on August 15, FDA defined categories of dietary supplements as they will most likely appear on the FSMA re-registration forms in ways different than how they are already defined in federal law. AHPA requested this be changed, so that the categories long familiar to industry (DHSEA’s language of “a vitamin, a mineral, an herb or other botanical . . .”) would also appear on the re-registration forms, rather than have firms guess where their products fit in the realigned categories, which read: “Proteins, Amino Acids, Fats and Lipid Substances; Animal By-Products and Extracts; Herbals and Botanicals.”
There was no immediate official reaction to the GMA letter. FDA did not immediately respond to a request from NutraIngredients-USA for comment on the when the updated forms and final guidance might be issued.