SIDI Supplier Protocol Update Adds To Burgeoning Self-Regulation Library

SIDI's draft protocol update incorporates changes to guide compliance with rules established by FSMA relevant to supplement firms and adds information on economically motivated adulteration and determining whether dietary ingredients are grandfathered as compliant under DSHEA.

A trade group panel adds to the dietary supplement industry's self-regulation program inventory with an updated guide for qualifying ingredient suppliers, a big piece of FDA’s good manufacturing practices rule.

The Standardized Information on Dietary Ingredients Work Group's updated draft released June 1 incorporates changes to guide compliance with rules established by the Food Safety Modernization Act that are relevant in the supplement sectoir, including the foreign supplier verification program. It also adds information on stating whether dietary ingredients are grandfathered as compliant under the Dietary Supplement Health and Education Act.

The SIDI protocol draft continues the industry's upswing in self-regulation through developing and publishing guides or other documents to help manufacturers and marketers comply with FDA's GMP rule and other regulations. The work group, comprised of staff from the Council for Responsible Nutrition, the United Natural Products Alliance and the Consumer Healthcare Products Association and representatives of member firms, is accepting comments on the draft from industry stakeholders and regulators through July 3.

The update comes a month after CRN launched the Supplement Online Wellness Library as a registry for labels and other information accessible in two tiers, to anyone or only to users cleared by the manufacturers or marketers of a product. Additionally, FDA exclusively can access information some firms post on Supplement OWL but often not on labels. (Also see "Supplement OWL Registry Counts On Peer Pressure To Spur Use" - HBW Insight, 5 May, 2017.)

Also recently, US drug store chain giant CVS Pharmacy said by 2019 it will require its vitamin and supplement suppliers to show third-party testing of their ingredients and finished-product testing when certain ingredients are used. Unlike Supplement OWL, CVS' initiative imposes a product-testing requirement. (Also see "CVS Standards: Another Step In Supplement Industry Transparency Evolution" - HBW Insight, 26 Apr, 2017.)

Another developing self-regulation program is the Supplement Safety and Compliance Initiative headed by the Natural Products Association and targeting reducing safety risks and recalls by converging effective supplement safety management systems. NPA is working with [GNC Holdings Inc.], [Vitamin Shoppe Inc.], smaller supplement businesses, discount retail giant Walmart and leading natural products chain Whole Foods Market and trade groups from the food and manufacturing sectors in the initiative announced in January. (Also see "NPA, Retailers Tackle Accountability: Health & Wellness Industry News Roundup" - HBW Insight, 12 Jan, 2017.)

Also in January, CRN and the International Probiotics Association began developing scientifically based best practices guidelines for labeling, storing and stability-testing supplements and functional foods containing probiotics.

While SIDI formed in 2006 and published its first draft protocol in 2008, GNC moved to center stage in self-regulation in 2015 when it spearheaded starting an industry coalition to improve its image with consumers and later developed guidelines for its suppliers on tracking ingredients used in supplements from cultivation to harvest and through to processing, storage, transportation and testing. (Also see "GNC Looks To Boost Trust With Supply Guidelines, Margins With More Franchises" - HBW Insight, 7 Mar, 2016.)

One of GNC's industry sources was the American Herbal Products Association's good collection practices published in 2006. AHPA also will keep GNC's guidelines up to date so manufacturers and marketers remain effective in ensuring quality and regulatory compliance in their supply chains.

More Guidance

This variety of published and pending information targeting regulatory compliance should provide answers on most every question firms of any size or purpose have about supplements GMPs and other relevant FDA regulations. While the separate documents largely address different components of supplement manufacturing and marketing, they are not offering differing advice when their discussions overlap.

"If there is more than one document, definitely use them, read them all and I'm sure they all have value," said Gisele Atkinson, CRN's vice president, quality and technical affairs

"Whatever guidelines are out there, if there is more than one, I would use both. I would look at both and I would make sure I incorporated everything. More information is better for me," Atkinson, who joined CRN in August after 10 years in quality assurance and quality control posts with nutritional product firms, said in an interview. (Also see "Health & Wellness Industry News Roundup: Week Of July 25" - HBW Insight, 1 Aug, 2016.)

The protocol is a brief document, with the draft update's introduction and guidance page count trimmed from the current edition by one to 13, and provides templates for stating information about a dietary ingredient a supplier typically needs to provide to a manufacturer.

"We didn't want to get into too much detail and have people feel like they had to do things in a certain way. It's a guideline that also gives them some room to adapt it into their quality systems," Atkinson said.

Although using the protocol does not garner a SIDI seal of approval manufacturers can add to product labels, the protocol could become a calling card for suppliers.

"That could somehow indicate to any perspective costumers that you have all this relevant information ready for them to view," Atkinson said.

Supplement manufacturers are subject to GMPs FDA published in a 2017 final rule and largely are exempt from FSMA's manufacturing regulations. However, dietary ingredient suppliers, even those that perhaps work only with supplement manufacturers, are covered in the regulations established by 2011 legislation.

For FSMA's hazard analysis and preventative controls requirements in particular "this would be a big help," Atkinson said.

"I think those are going to become more relevant and I think people are going to start turning, even more so to these guidelines," Atkinson said.

Guidelines on stating whether dietary ingredients are grandfathered under DSHEA have taken on added importance as the industry and FDA argue about information and documentation needed to prove that an ingredient is not subject to the act's new dietary ingredient notification requirement. (Also see "Revised NDI Notification Draft Guidance Shrinks Divide Between FDA And Industry" - HBW Insight, 11 Aug, 2016.)