“As a consultant, I always sit in during audits for my clients,” he told us, referring to an audit provided by one leading certification lab in particular.
“But we have a lot of clients who request a program that looks beyond GMPs,” he added.
That was the gap he believes his new Dietary Supplement Compliance Program Certification can fill. “We’re looking at the labels that other programs aren’t looking at, we’re looking at a snapshot of advertising that other companies aren’t looking at, and we’re also looking at GMPs.”
Unlike other certificates, it's not meant to be an on-product seal, and it’s granted to companies and brands instead of each SKU.
Also, the audit doesn’t involve steps above-and-beyond what regulations are asking for. It simply assesses whether a company is abiding by regulations at both federal and state levels (from advertising to adverse event reporting to labeling), and the audit changes as regulations change as well.
On the firm’s website, it explains: “We audit your company much like the FDA would to give you total preparedness. While other certification companies cater primarily to the approximately 3% of companies that do their own manufacturing, and only look at their manufacturing practices (cGMPs), we also partner with the majority of you that contract out manufacturing.
“We ensure that you are not only taking the right steps with your manufacturing, but also with your labels and advertising.”
Getting the word out
Walcker has been in the dietary supplement industry for about 20 years, starting as a GNC manager in his college days.
He then worked for multi-level marketing dietary supplement company Nature’s Sunshine Products as a research scientist, where he first became interested in regulation. He then moved on to several regulatory affairs positions in different companies.
Currently, he is the VP of regulatory and quality for collagen and bone broth supplement specialist Dr. Axe Ancient Nutrition. His consultancy firm is a side passion he's been doing since 2013.
Walcker is spreading the word out about this new certification by email blast to his contacts within the industry. “Pretty much any business model who touches dietary supplements we’ll work with,” he said.
“So far in the program we have an array of company types—we have a contract manufacturer, we’ve got internet marketers, and a company that strictly does fulfillment,” he added.
Focusing on new companies or new industry entrants
There’s a mix of B2B and consumer-facing elements of the certification. Walcker intends it to communicate that a company is compliant to regulations to a client’s potential business partners or consumers, but ultimately it’s a measure for peace of mind of the audited company itself.
“There are a lot of internet marketers, which make up the vast majority of companies that have not much access or knowledge on this,” he said.
“These small internet marketing companies may not be aware that they have requirements in terms of [Standard Operating Procedures], or product complaints, adverse events, supplier qualification—all those things. We’re helping getting those things in place and making sure these smaller companies have readiness for [regulatory enforcement visits].”