The notice said that no dietary supplement ingredient company has yet submitted a petition for skip lot testing, a process in which manufacturers can bypass 100% identification testing and instead use a validated statistical model, cutting time and costs.
However, the Natural Products Association (NPA), the trade group which pointed out the Federal Registrar notice’s discrepancy, filed such petition on behalf of its member Bergstrom Nutrition earlier this year.
The NPA also argued that filing a petition for 100% identity testing exemption takes around 200 hours of work—from compiling all past quality logs to conducting statistic calculations—instead of eight hours, as posited by the agency’s notice.
“FDA has never submitted one of these. We’re the only organization, working with Bergstrom, to submit one. So I think we have a better data,” Daniel Fabricant, PhD, president and CEO of NPA, told us.
“It takes time,” added Corey Hilmans, PhD, senior vice president of scientific and regulatory affairs. “I don’t know of a citizen’s petition to the agency that’s ever taken eight hours. It would be in the Guinness Book of World Records.”
“We don’t want to take a knock that no one has ever submitted which is why it’s important to get it right that yes, one did submit, and this is how long it took them,” he added.
Possible time and cost savings
The agency issued the notice as part of a routine to streamline the collection of information, based on review and clearance under the Paperwork Reduction Act of 1995.
“Bergstrom was the first firm to file this type of request, and we expect this could have big implications across the industry once approved,” Dr. Fabricant said. "We look forward to working with the agency to highlight member firms with excellent track records.”
In an interview with NutraIngredients-USA in January, Dr. Fabricant said that Bergstrom Nutrition is in a unique and advantageous position to perform skip lot testing because it manufactures just one ingredient: Synthetic methylsulfonylmethane (MSM).
“In the pharma world, they don’t do 100% ID testing. They do skip lot testing. Bergstrom is applying similar statistical rules here,” added Tim Hammond, sales and marketing VP at Bergstrom.
“Our goal is to increase efficiencies for our customers thereby saving them time and money.”