On December 2, 2011, Michael McGuffin hunched over his computer screen, polishing off a 75-page rebuttal to the FDA’s controversial draft guidance on how New Dietary Ingredients (NDIs) should be regulated. If the guidance were to be enforced as written, the smart minds in the supplements industry saw clearly its potential to kill product innovation and pull products, including herbs and botanicals, from store shelves.
So in typical McGuffin fashion, the longtime president of the American Herbal Products Association got busy, scouring all 86 pages of the document line by line before delivering a painstakingly thought-out response just moments before the December deadline.
“Michael knows this document better than anyone outside of the FDA,” noted Daniel Fabricant, director of FDA’s Division of Dietary Supplements, during a recent panel discussion on NDIs.
McGuffin’s response to the NDI guidance marks just the latest example of effective leadership over a 40-year career which colleagues say has helped to transform the herbal products industry into a more mature and respected one. Since becoming AHPA president in 1999, McGuffin has helped to standardize herb names and product warnings on labels, to convince the legislature to require adverse event reporting, and to promote better manufacturing and growing practices by companies.
“He’s been responsive on countless regulatory issues over the years,” says American Botanical Council director Mark Blumenthal, a founding board member of AHPA. “Michael’s efforts have given the industry not only a position of credibility, but a position of security. There is nobody on the herbal scene right now who has done more for the industry than Michael.”
McGuffin’s fascination with herbs began at age 10 when he stumbled upon some sassafras in the woods near his home near Columbia, Maryland. He dug it up and promptly made his first batch of Michael’s Root Beer in the family kitchen. Then he headed back to the woods to see what else he could find. “I started to know a lot of the plants as a kid,” recalls McGuffin, now 60.
After a brief stint studying engineering at Johns Hopkins, McGuffin took a road trip to California in 1973. He never left. In 1974, he joined some friends selling fresh fruit and dried bulk herbs on the Venice Boardwalk. Venice Fruit Tramps was born. In 1977, he went to work for One Life Natural Foods, where he became store manager and met his soon-to-be business partner, an acupuncturist and herbalist named Janet Zand.
The herbal products industry was still in its infancy, with small, family-owned companies like Nature’s Way and Herb Pharm slowly reviving the lost art of herbal therapy. The industry barely registered on the radar screen of federal regulators, and to consumers it was largely viewed as a fringe element of the counterculture. “Companies didn’t start out with the idea that, ‘Hey, we can make some money off this,’ ” recalls McGuffin. “They were passionate proponents of herbs because they saw the incredible health benefits of using them in their own families.”
In 1979, McGuffin and Zand pooled their $2,200 in savings and founded McZAND Herbal Inc., the first company to create a lozenge free of cane sugar. Twelve years later, the industry began to boom and the FDA began to clamp down on herbal imports and label claims, suggesting that herbs be regulated more like food additives. McGuffin decided it was time to take action to defend the industry he so believed in.
McGuffin joined the AHPA board in 1991. Eight years later, he left McZAND Herbal and became AHPA president. “Early on, I made a list of all of the things our critics were saying about us—all of the things they would change if they could,” he recalls. Topping the list? Requirements for companies to report adverse health reactions to the government, for manufacturers to meet certain quality standards, and that products contain exactly what they purport to contain. In 2006, after years of work on the part of McGuffin, the FDA established its Adverse Event Reporting System for dietary supplements.
“Michael really led the pack on making that happen,” says Loren Israelsen of the United Natural Products Alliance. “It’s really rare to find someone in this industry who has a rich technical background, is adept on the D.C. scene, and understands the ethos of the industry. He is a very smart guy.”
In recent years, McGuffin has also worked hard to educate the supplement industry as a whole about new GMPs, and edited two critical books for the herbal products industry: Herbs of Commerce, which offers standardized names for herbs; and the Botanical Safety Handbook.
As far as the NDI debate goes, he’d like to think that work is behind him. (McGuffin remains confident that, given industry’s clear rejection of the draft guidance, the FDA will work to overhaul it.) Going forward, he sees a bright future. “There was a time when people actually believed the herbal products category could be pushed out,” he says. “Nobody thinks that anymore.”