The original registration period was set to open on Oct. 1, but the Food and Drug Administration announced at the end of September the it was not ready to accept registrations at that time. The guidance document governing the process was still in draft form and was under review at the Office of Management and Budget.
It has now been released in final form, with little if any modifications from the draft form.
“If it’s updated it’s mostly dates,” Justin Prochnow, a Denver-based attorney with the firm Greenberg Traurig, told NutraIngredients-USA.
A number of companies have already registered their facilities with FDA under the 2002 bioterrorism law. But that doesn’t exempt them from the new requirement.
“The biggest thing is that everyone has to register. Even if a company is registered now, everyone has to register during that period,” Prochnow said.
The deadline for the registrations to be completed has apparently remains the previously mandated Dec. 31.
Companies can reference the document on FDA’s website on the FSMA registration process. The document includes an FAQ section as well as a link to the full text of the law , a guidance on food categories , and a guide to using the online registration tool . Companies have the option to mail in a form if they so choose.
Law affects both food and supplement companies
The Grocery Manufacturers Association (GMA) has taken the lead in interacting with FDA on how FSMA affects food manufacturers.
GMA send a letter to FDA in late September seeking guidance on the registration process, an appeal that would appear to now have been fulfilled. The letter was sent on the behalf of a group of trade associations in the food retailing, manufacturing and warehousing industries, and included the American Herbal Products Association (AHPA) as the lone representative of the dietary supplement realm.
AHPA has taken the lead in interacting with FDA about the various portions of FSMA and how they affect companies in the dietary supplement space. The other supplement industry trade associations, who reacted positively to the law's passage, have been less engaged on the issue of trying to fine tune the law's provisions.
IN comments on the law filed in October, 2001, AHPA noted that Section 207 of FSMA amended the Federal Food, Drug, and Cosmetic Act by changing the criteria under which FDA can detain a food – including dietary supplements – from 20 to 30 days.
This was amended to give FDA authority to order detention of a food if it has "reason to believe" that the food is "adulterated or misbranded". This was previously limited to instances in which the agency had "credible evidence or information" indicating that a food "presents a threat of serious adverse health consequences or death”.
Comments filed in response to the new Act by AHPA urge FDA continue to use its administrative detention authority sparingly.
It is also noted by the trade association that Congress did not limit administrative detention to food that is in domestic commerce, such that "any detention of food that is made due to FDA's determination that is has a reason to believe that the food is adulterated or misbranded, including detentions at a point of importation or of domestic possession, should be considered to be an administrative detention."
“If FDA agrees with this analysis, any adulteration – or misbranding-based adulteration – would be subject to certain rules, including that such detention could not exceed 30 days,” stated AHPA.