NPA files petition for approval of skip lot ID testing

By Hank Schultz contact

- Last updated on GMT

Bergstrom makes one ingredient--OptiMSM--meaning chances of cross contamination are nil, NPA says.  Bergstrom Nutrition photo
Bergstrom makes one ingredient--OptiMSM--meaning chances of cross contamination are nil, NPA says. Bergstrom Nutrition photo

Related tags: Industry, Nutrition, Material

The Natural Products Association has filed a petition on behalf of member Bergstrom Nutrition asking FDA to grant reduction of identity testing frequency based on the company’s track record. If successful, the petition could lower costs in the industry, the group said.

NPA president Daniel Fabricant, PhD said this is the first time that a company has filed such a citizen’s petition seeking flexibility on the requirement for 100% ID testing.  Bergstrom’s situation is unusual among dietary ingredient suppliers in that it makes only one ingredient: OptiMSM, a branded version of methylsulfonylmethane (MSM). The company, based in Vancouver, WA, has been developing the ingredient for several decades.  The company’s long development cycle has led to a production process whereby the molecule can by synthesized economically and, most importantly, entirely consistently, said Tim Hammond, sales and marketing VP at Bergstrom.  Like some other dietary ingredient suppliers who work with this production pathway, Bergstrom emphasizes the advantages in purity and fully predictable supply.

Transparency about sourcing

“We are subtle about talking about having a synthetic ingredient,  ​Hammond told NutraIngredients-USA.  While the company is not waving the flag of that production process from the mountaintop, Hammond said it also doesn’t pay to try to obscure an ingredient’s provenance with what Bergstrom views as cloudy marketing language.

 “There are some marketers out there talking about having ‘wood sourced MSM. That kind of raw material hasn’t been around since at least 2010. And some talk about ‘organic sulfur in their production processes.  We want to be the source of facts when it comes to MSM,​ Hammond said.

Pharma-like process

Fabricant said Bergstrom’s long history with the ingredient and tightly controlled production means that a skip lot testing program using a validated statistical model can satisfy the intent of the ID testing requirements spelled out in the GMP rules.  The situation here is more akin to the production of pharmaceuticals than it is to the sourcing and handling of botanical raw materials, he said.

“In the pharma world, they don’t do 100% ID testing.  They do skip lot testing.  Bergstrom is applying similar statistical rules here,​ he said.

Bergstrom Nutritions long-standing commitment to providing consistent high quality methylsulfonylmethane from our dedicated facility makes us a perfect fit for a petition of this nature,​ said Rodney Benjamin, Bergstrom’s director of R&D and technical support.

 Our goal is to increase efficiencies for our customers thereby saving them time and money,​added Hammond.

If the petition is successful, it could become a model for some other ingredients and manufacturers, Fabricant said. The petition is in line with the Trump Administration’s stated goal to cut back and streamline regulation, he said.

Bergstrom ranks among the most reputable companies in the industry and allowing them to streamline their approval process for products with strong science and statistical evidence will save the government and consumers money and increase the quality of nutritional supplements. This is the first time anything like this has been done and we expect this could have big implications across the industry once approved,​ he said.

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