Tallahassee Journal

FDA tells herbal supplement maker to play by new rules

FDA tells herbal supplement maker to play by new rules

If it looks like dandelion, smells like dandelion and tastes like dandelion, does that mean it is dandelion? Not as far as the U.S. Food and Drug Administration is concerned, and that’s a problem for Urban Moonshine, a small but growing herbal supplement business in Burlington. The company, founded by Jovial King in her kitchen in 2009, will do more than $1 million in business this year, and employs 17 people at its headquarters on South Champlain Street. But now King finds herself spending tens of thousands

If it looks like dandelion, smells like dandelion and tastes like dandelion, does that mean it is dandelion? Not as far as the U.S. Food and Drug Administration is concerned, and that’s a problem for Urban Moonshine, a small but growing herbal supplement business in Burlington. The company, founded by Jovial King in her kitchen in 2009, will do more than $1 million in business this year, and employs 17 people at its headquarters on South Champlain Street. But now King finds herself spending tens of thousands of dollars she didn’t expect to spend to comply with relatively new regulations issued by the FDA for dietary supplements.

Urban Moonshine is required to prove that what they believe to be dandelion really is a dandelion by subjecting it to third-party testing — in this case at a lab in California — to identify its chemical fingerprint through chromatography. The company will have to submit that data, and similar data for some 60 other ingredients it uses, to the FDA to be in compliance. “The FDA’s mantra is, ‘In God we trust, everyone else must prove data,’” said Guido Mase, Urban Moonshine’s chief herbalist.

Michael McGuffin, president of the American Herbal Products Association, said the regulations — issued in 2007 with a June 2010 deadline for compliance — were used to crack down on weight loss supplements with undisclosed ingredients such as sibutramine, which has been associated with strokes and heart attacks. “It’s a complex regulation, a regulation that was written to a large degree to control the bad guys and make sure people who want to cheat can’t cheat,” McGuffin said.

Herbal supplements came under the same strict guidelines for documenting ingredients and the manufacturing process, despite McGuffin’s efforts to carve out less burdensome regulations similar to those governing food manufacturers. McGuffin notes the burdens imposed by regulations are supposed to be balanced by the benefits to public health. He believes in this case, that balance is off.

 of dollars she didn’t expect to spend to comply with relatively new regulations issued by the FDA for dietary supplements.

Urban Moonshine is required to prove that what they believe to be dandelion really is a dandelion by subjecting it to third-party testing — in this case at a lab in California — to identify its chemical fingerprint through chromatography. The company will have to submit that data, and similar data for some 60 other ingredients it uses, to the FDA to be in compliance. “The FDA’s mantra is, ‘In God we trust, everyone else must prove data,’” said Guido Mase, Urban Moonshine’s chief herbalist.

Michael McGuffin, president of the American Herbal Products Association, said the regulations — issued in 2007 with a June 2010 deadline for compliance — were used to crack down on weight loss supplements with undisclosed ingredients such as sibutramine, which has been associated with strokes and heart attacks. “It’s a complex regulation, a regulation that was written to a large degree to control the bad guys and make sure people who want to cheat can’t cheat,” McGuffin said.

Herbal supplements came under the same strict guidelines for documenting ingredients and the manufacturing process, despite McGuffin’s efforts to carve out less burdensome regulations similar to those governing food manufacturers. McGuffin notes the burdens imposed by regulations are supposed to be balanced by the benefits to public health. He believes in this case, that balance is off.