Anaheim, CA—Supplements maker Jarrow Formulas, Inc. (JFI) of Los Angeles, CA, organized a visit from Congressman Ted Lieu (D-CA) to Natural Products Expo West on March 8. Lieu represents California’s 33rd District, a slot formerly held by Henry Waxman, an outspoken critic of the supplements industry.
“Given that Congressman Waxman was such a long-time opponent of the supplement industry, we saw it as a strategic opportunity to transform his seat to one of being a proponent,” states Rory Lipsky, senior director of business strategy for JFI. “In addition, since Congressman Lieu sits on the House Committee on Oversight and Government Reform, we felt he would be a powerful ally over the long run and also in the short run against the current overreach of the NY attorney general.”
In a small meeting hosted by JFI, several industry stakeholders came together to discuss concerns of relevance to the supplements industry with the Congressman. In addition to outlining these issues, the group asked Lieu to join the Dietary Supplement Caucus, and he agreed.
Topping the list of issues were the recent cease-and-desist letters issued by NY Attorney General (NYAG) Eric Schneiderman to four retailers for selling herbal supplements that failed DNA identity testing. The use of DNA testing at the NYAG's request has drawn sharp criticism from industry since an herb’s DNA is rarely preserved after extraction and processing. Therefore, DNA testing is not often used on its own for finished products testing. Industry members said it would be helpful to have a government-accepted protocol for this sort of testing, and underscored that additional regulations aren't needed. Instead, they argued that it would be more helpful to have proper enforcement of the regulations that are already in place.
Jarrow Rogovin, president of JFI, made the point that regulators don't always make full use of the resources at their disposal. “Nutritional issues are not being responded to or analyzed,” he stated. “The Office of Nutrition, Labeling, and Dietary Supplements is in a state of disarray.”
Those in the room referred to a revolving door of four temporary directors of dietary supplements at the U.S. Food and Drug Administration (FDA) in the past year.
Coupled with that was an issue raised by Michael McGuffin of the American Herbal Products Association. He stated that industry is still owed a final guidance on new dietary ingredients (NDIs). A draft guidance was issued in July 2011, which industry felt was a reinterpretation of the law, almost turning the NDI process into a drug-like approval process. FDA agreed to revise the draft after receiving a mountain of comments from industry. Despite the promise for the final version to be completed by the end of 2014, no additional guidance has been issued.
“We want them to give them the guidance we need, not the one they wish we had,” McGuffin stated. He suggested the guidance be distributed in parts, starting with the sections about which industry and FDA were in agreement. “Give us the nonconfrontational part first, and then deal with the rest,” he suggested.
Additional concerns included eliminating the trade barrier to sell dietary supplements legally overseas and unscrupulous e-commerce companies skirting proper importing and distributing regulations by selling supplements online in venues like Amazon, Sears and Walmart e-marketplaces. Some of what is sold there is outdated (and illegally repackaged) or even stolen product, and the identities of these marketers are kept confidential by the marketplaces.
“Why is it the system is so leaky that drug-spiked herbals are getting through?” asked Tom Tierney, president of Vitatech.
McGuffin offered up to the Congressman some information about the economic benefits of supplements such as vitamin D.
JFI and others in the meeting plan to be in touch with Lieu with a written point-by-point description of their key concerns. States Lipsky, “We feel that we need to continuously build friendships in both the House and the Senate, so this is part of our ongoing efforts.”
Published in WholeFoods Magazine, April 2015 (online 3/10/15)