Archbold sat down with NutraIngredients-USA at the Raw Materials and Supply Chain Summit put on by the United Natural Products Alliance this week in Salt Lake City to discuss the new standards. GNC based the 58-page draft document of the new specifications on earlier work done by the American Herbal Products Association, a provenance the company freely admitted.
“Some of the concepts are not new but now they have been brought across the finish line,” Archbold said.
Bringing suppliers into the fold
The supply end of the dietary supplement industry has long been a sticking point in terms of Good Manufacturing Practice compliance. When these rules were added on to DSHEA, they omitted ingredient suppliers. In the intervening years, ingredient suppliers have been required to adhere to the overarching rules that cover food facilities, such as general cleanliness standards and methods to guard against microbial contamination or contact with insects or other animals and the requirement to register as food facilities under the Bioterrorism Act. But they have not been required to conform to Part 111, the more focused GMPs for dietary supplements.
The responsibility to ensure that incoming raw materials meet GMP specs was left solely to the manufacturers receiving this material. FDA mandated that identity tests be conducted and suppliers be verified, but the GMPs as they stand are less prescriptive in this area than in other parts of the manufacturing chain. The rules state, for example, that identity tests should be scientifically valid and fit for purpose, but do not prescribe which tests should be done.
Relying on this “pull” situation to raise the compliance bar for suppliers—in other words a situation in which each manufacturer spells out for its own suppliers what practices they need to adhere to in order to continue the business relationship—is no longer viable, Archbold said. It’s time for the responsibilities of ingredient suppliers and the procedures they should follow to be spelled out in black and white and to make these standards common across the industry, he said.
“It’s time to have the experts across the industry align to have full traceability,” Archbold said. “We chose to play a major part because we are a significant player in the space.”
GNC released a 58-page draft version of its new raw material specifications. Those specs will now undergo a period of comment and review, a process which will be managed by AHPA.
What the new GMPs say
The draft version of the standards spells out specifications and procedures for every step of the process of harvesting, processing and shipping botanical ingredients, whether they are cultivated or wildcrafted. There are specs around assessing the sites where the plants are growing, including collecting weather and site history data, and procedures to ensure that botanicals are harvested in a way that preserves their biological value as well as ensures a continued crop. This section of the GNC document was based largely on AHPA’s earlier Good Agricultural Collection Practice document as well as standards set out by the World Health Organization. There is also a lengthy section pertaining to post harvest processing, including design and cleanliness of facilities, what kind of equipment should be provided and standards for process control. The specifications also address testing and laboratories facilities and documentation standards including the need for master manufacturing records and batch production records. Much of the standards in this portion of the document were adopted from 21 CFR 111.
Need for urgency
Some earlier stabs at writing standards of this sort, whether it was AHPA’s own first go round with the raw material standards or the SIDI working group facilitated by the Council for Responsible Nutrition which sought to standardize how information was recorded by suppliers, have suffered from lukewarm uptake by industry. No one disputed that these were good ideas, but there was little urgency on the part of companies to adopt them. Archbold said that GNC intends to inject that urgency into the situation. The company is moving forward with the standards immediately, and will incorporate revisions as they come along.
“By the end of the year we will only work with companies that are compliant with these GMPs. As one of the significant players in the industry we can help bring some weight to this. What we are now looking to do is have the industry adopt these more broadly,” Archbold said.
Part of the pressure comes from what Archbold said is a crisis of confidence among consumers brought on by negative media coverage that arose in part from the actions of New York Attorney General Eric Schneiderman. While it has been reported that supplement sales have not taken much of a hit in the past year, Archbold said that’s not what GNC has seen.
“If you were to look at the specialty retailers you might feel differently. I think you would see that among them there has been more of an impact,” he said.
Archbold said there is a need to move swiftly to give the impression that the industry is working to address perceived issues of quality. Ideas have a life cycle and momentum of their own in society, Archbold said, and once consumer confidence starts to waver, it can take a long time to get it back.
“The negative media coverage can have a long term chilling effect. It undermines consumer confidence and the negativity begets more negativity. The NYAG investigation was resolved satisfactorily for us; they found no issues with our products or our processing. But the damage was done on the consumers’ mindset,” he said.