Supplier Verification Key to New FDA Rules
Long before the New York Attorney General made a move to DNA test mainstream supplement products (and well before the Dietary Supplement Health and Education Act of 1994 [DSHEA], 21 CFR 111 and now CFR 117), foods and supplements were prone to adulteration—both deliberate and unintentional.
In today’s modern supply chain, ingredients generally come in powder or liquid form, masking their true identity to the naked eye. They are shipped from afar—and grown and processed from even farther. Their travel across dusty roads and through busy ports is accompanied in many cases simply by a piece of paper that “certifies” their analyses.
The adulterants of today are similar to those of yesterday, but more advanced. Undeclared fillers and analysis-interfering ingredients are today’s sawdust and snake oil. And even raw materials innocently misidentified or mistested can ruin all the good intention in the world.
“Caveat emptor,” say some suppliers, “I don’t confirm my supplier’s certificate of analysis (CoA) because that’s my supplier’s job.” Passing the buck doesn’t—or shouldn’t—work in today’s regulated industry. A money-back guarantee cannot erase the taint of inferior ingredients consumed by people daily, and in relatively large amounts for their health.
When the analysis certified by that piece of paper is a third- or fourth-hand document whose validity has not been independently verified or tested, a shred of trust quickly turns into a shroud of mystery: Who tested the material? How did they test it? Can we trust the results?
On another part of the supply-chain spectrum exists a lot of upstanding, quality-invested companies, which simply come from the old days and have not accumulated sufficient expertise or information about how their ingredients are made or tested. Now we are made to actually test against the spec instead of trusting it—isn’t that enough?
Not anymore. Many are damning the attorneys general for their lack of expertise about the uses and limitations of DNA testing of botanicals. But others believe that their actions, and the new FSMA (Food Safety Modernization Act)/CFR 117 rules serve not as a red herring, but a beneficial spotlight on some real issues: What tests are suitable for identity? How do we ensure identity and ingredient integrity is maintained?
Many of those who are committed to quality see the rainbow in the storm, and want to invest in doing the right thing as part of continuous improvement. They know transparency and traceability are not just buzzwords: the concepts actually mean something to CPG (consumer packaged good) marketers—and not just because they are starting to mean something to the end consumer.
The new requirements have a catch: maintaining and improving on the principles of transparency and traceability requires more than just creating product specifications and testing against them. Adopting these values to meet the new requirements will require investment in strong relationships and control of supply chains, and proper audits and qualification of suppliers. Trust but verify.
Now that many U.S. manufacturers are getting up to par on GMPs (good manufacturing practices), FDA appears to be (rightfully) focusing on suppliers of ingredients imported from foreign countries such as China and India. So, under the new CFR 117, supplier verification programs are required. Some say the new requirements, which also require verification of food safety principles like HACCP, are the missing link between the requirements of DSHEA and how to responsibly ensure food and supplement product safety and integrity.
Here’s one example to illustrate: many factories overseas performing extractions also process pharmaceutical actives, including cytotoxic drugs and other materials that can possess bioactivity at low concentrations. These materials, which could cross-contaminate a natural product brand’s material, are rarely listed on the specification. The reason stated for the absence of cross-contaminants on the spec is that they are unnecessary—because cleaning is performed between manufacturing runs. But how is the validation of the cleaning performed? Are all nooks and crannies of the production line cleaned? A weak cleaning validation or pre-production line clearance, lacking any actual limits or in-process testing for contaminants, serves as a key difference between a safe, legal product and an adulterated, potentially unsafe one.
Ingredient manufacturing facilities should perform cleaning validation, and should let their customers know of potentially toxic products that are made on the same production lines. This information isn’t found on the ingredient specification, but is part of a good supplier qualification program. If a brand doesn’t ask about cleaning validation or audit the facility’s production records, it would never know whether the cleaning was effective to prevent adulteration or a potential product liability issue.
“Trust but verify” is the central mantra of GMP and of good quality practices. For these reasons, and many others, many experts believe the new CFR 117 is a critical and important move toward improving product quality and integrity in dietary supplements. So, if the industry in 2015 is remembered by the word “identity,” 2016 may be known for the words “supplier qualification.”
If a brand isn’t well-versed in these areas, help is available. New compliance programs offered by groups such as NSF International, IDDI and others work to close gaps by offering independent review and verification of supplier GMPs. Others focus on verifying ID and product specifications, based on oft-cited FDA inspection violations. New independent supplier verification services are available to assist clients with meeting the new rules.
Once, during a foreign-supplier qualification audit, I politely noted a potential risk to product safety that was due to the absence of a critical control point. After the facility supervisor’s response along the lines of “it’s not a big deal—we have never had a problem noted,” I acknowledged that may be the case. But now knowing the potential risk, would he let his children consume the product without fixing the issue? There was a pause in his response.
Likewise, we should all be willing to swallow the product whose safety and quality we are responsible for. But before taking the plunge, we should get to know our suppliers, and verify their quality practices.
By: Blake Ebersole
This article was first published by Natural Products Insider, December 2015.