Supplement Perspectives

DSHEA, 20 Years Later: More Teeth or Less Bite?

<p>The migration of the natural products industrys best and brightestspecifically Cara Welch and Dan Fabricantcould be just what DSHEA needs, writes Anthony Almada.</p>

The groundswell of industry and consumer support that co-created what is known as DSHEA (Ive heard it pronounced at least three different ways) is a public relations and consumer outreach case study, pre-Internet and social media. I recall the blackout day, when a number of natural products retailers draped their supplement shelves with black tarps, trash bags, or simply Not For Sale placards, just to engender discussions with agape consumers and inspire them to write to their Congress member(s). Then the potential tipping point video with Mel Gibson, exclaiming Its just vitamin Clike oranges as hes being handcuffed in his own kitchen by a SWAT team.

When DSHEA passed I was co-leading EAS from our humble, seaside offices in Pacific Grove, California. Many prognosticators were jockeying over what DSHEA would usher in, from a Wild West of products and claims to a sanitized, quality-driven, innovative industry. New Dietary Ingredient rules were an untested black box, first opened in 1995 with Stevia (for Sunrider Intl.) by veteran regulatory attorney Patrick Noonan. The black box has shape-shifted dramatically since then. The promulgation of current Good Manufacturing Practices (cGMPs) regulations had a gestation period that would make an Alpine Salamander feel like it had to work overtime on a weekend, to conceive and deliver its progeny.

With the cGMPs came the most robust, almost continuous, string of FDA warning letters and actions. Soon after the final compliance dates (June 25, 2010) for dietary supplement cGMPs passed, a possibly more significant action transpired at FDA, which preceded the incremental FDA enforcement activities: the hiring of Daniel Fabricant, Ph.D. in February 2011.

I had the distinct pleasure and privilege of working with Dan when he assumed his first industry seat (as the vice president of science and regulatory affairs, and later, interim CEO, for Natural Products Association), starting around 2005. He assumed the role as chair of the Committee for Product Label Integrity (ComPLI), of which I participated for several years. Dan was incisive, imparted rigor, fostered lively debates, and was inspired to make a difference in the industry. Dan is a pharmacognosy scientist who trained under his preeminence, the late and beloved Dr. Norman Farnsworth. Dans candor and scientific acumen bolstered NPAs status in Washington, enough to elicit an employment offer.

From my vista, Dan would appear to be the first to cross what some consider enemy lines, leaving a VP post in the natural products industry and entering the upper ranks at FDA, with a mandate to guide FDA through the dietary supplement cGMP morass and safety vigilance. Dans familiarity with the natural products industry has made him a celebrity on the industry speaking circuit. In less than three years since Dan joined FDA another brain drain struck NPA. Dans successor, Dr. Cara Welch, joined FDA mere weeks ago, leaving NPA as senior vice president of scientific and regulatory affairs.

What may have accelerated her departure across the aislein addition to possible/likely encouragement from Dr. Fabricantis Caras husband, a chemistry, manufacturing, and controls/product quality reviewer at FDA in the Office of Biotechnology Products. Dr. Welch brought poise, additional rigor (her dissertation focused on a Senegalese medicinal plants, and associated diagnostic characterization of naturally occurring bioactives, employing NMR), scientific brilliance, and a complementary gender strength to what remains a highly male-dominant industry.

Dr. Welchs role at FDA remains non-public but likely will involve a role in the Office of Dietary Supplements, and a close alliance with Dr. Fabricant. This dietary supplement industry expatriate duo brings insights and a buried bones perspective that can only augment FDAs enforcement of DSHEA. Will there continue to be more enforcement bites, or will the combined bite force of implementing initiatives co-crafted by Drs. Fabricant and Welch forge new teeth from the virgin dentin and enamel residing in DSHEA?

Mr. Almada has no conflicts to disclose.

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