Two trade groups that had an audience with the New York attorney general’s office in April said the AG’s office heard loud and clear that DNA barcoding is not appropriate for testing herbal extracts — but does not care.
“We raised issues about the appropriateness of DNA barcoding on extracts, we raised questions that DNA as an across-the-board test on raw materials is not appropriate in some cases, we raised with them that DNA is not the sole way you identify ingredients even at the raw materials stage, that it adds costs because it might not be the main test in many cases,” said Steve Mister, head of the Council for Responsible Nutrition, which sent a delegation to New York. “We believe they very much heard the message. But we believe they’re more interested in creating a consumer issue they can win than in the accuracy of their tests.”
Mister said he told the attorney general’s office staff — Attorney General Eric Schneiderman was not present at either meeting with the trades — if they were truly interested in consumer safety, they should investigate the problem with stimulants, steroids and outliers in the industry rather than mainstream companies with commodity ingredients.
Instead, it seems increasingly clear that the attorney general’s case is mostly predicated on PR for the AG—“almost governor,” as the abbreviation goes in political circles, as the last two New York governors both rose from the ranks of attorney general.
“This investigation has more to do with the perception of an active attorney general acting on behalf of consumers rather than recognizing legitimate problems in the industry,” said Mister.
For the Organic and Natural Health Association, president Karen Howard said the AG’s campaign will continue because “it has momentum and it has commitment.”
She took the opportunity to talk about supply-chain integrity — a related issue she said the AG staff found “compelling.”
“What’s important to know is they are committed to ensuring that the integrity of the supply chain is documentable,” Howard said. “Having said that, there is a desire to have uniform testing defined. We wouldn’t promote that — we understand, and even the FDA has specified, that testing varies. The characterization that this is all about DNA barcode testing and that’s all it’s about is not the intention.”
Howard said ONHA is interested in the idea of pushing GMPs down the value chain so that the rules apply to suppliers. As the regulations currently stand, the liability for product quality falls exclusively on the brand holder, aka, manufacturers. She noted that this is not under the jurisdiction of a state attorney general’s office as it’s really under the purview of the FDA. “It doesn’t hurt to have friends, right?”
Mister agreed that the problem remains with ingredient suppliers, even though most are responding to both market forces as well as rules such as the 2011 Food Safety Modernization Act (FSMA).
“You can’t test quality in at the manufacturer stage. You need it back on the suppliers,” said Mister, who nevertheless disagreed that putting GMPs on suppliers is the way to do it. “A lot of ingredient suppliers have had to up their game because finished product manufacturers are demanding it.”
FSMA has rules that are still being phased in pertaining to supply-chain integrity and traceability. The FDA is opening offices in China and India, and third-party certifiers are being authorized to check quality standards in countries with similar regulatory regimes as in the U.S.
“That frees up the FDA to go into countries that don’t have that infrastructure,” said Mister. “As these changes become implemented, they’ll cause changes.”
With quality being a pressing concern these days, the concern is whether the relatively slow implementation of new rules will happen fast enough to satisfy consumers who are reporting a deep suspicion of supplements quality.