Herb companies seek guidance

Todd Runestad, Content Director, NaturalProductsInsider.com, Sr. Supplements Editor

November 30, 2004

1 Min Read
Herb companies seek guidance

New botanical entries into the US market are being denied by the Food and Drug Administration for such fickle administrative reasons as not filing notification forms in triplicate, not providing the Latin name of the herb or not signing the form.

As FF&N went to press, trade groups were meeting with the FDA in the hope of getting some guidance from the agency.

?Most notices that have been denied have failed primarily due to the need for guidance,? said Michael McGuffin, president of the American Herbal Products Association. He said in many cases, the FDA never gets around to evaluating the safety aspects. Cases denied for any reason get stamped with the inflammatory word ?adulterated.?

An FDA scientist who works on the notifications said the most important question is what exactly constitutes a new ingredient. For instance, echinacea is traditionally extracted using a 35 per cent ethanol base. But what if a manufacturer uses 38 per cent, or 98 per cent? At what point does it become a new ingredient if an extraction solvent blend is modified?

The comment period ends on Dec 3, but trade groups are looking to extend it for an additional 60 days.

About the Author(s)

Todd Runestad

Content Director, NaturalProductsInsider.com, Sr. Supplements Editor, Natural Products Insider

I've been writing on nutrition science news since 1997. I'm The content director for NaturalProductsInsidercom and digital magazines. Other incarnations: supplements editor for newhope.com, Delicious Living and Natural Foods Merchandiser. Former editor-in-chief of Functional Ingredients magazine and still cover raw material innovations and ingredient science.

Connect with me here https://www.linkedin.com/in/toddrunestad/

My daily vitamin regime includes a morning smoothie with a range of powders including protein, collagen and spirulina; a quality multi, B complex, C with bioflavonoids, >2,000IU vitamin D, E, magnesium, high-selenium yeast, PQQ, choline, alpha-lipoic acid with carnitine, coQ10, fish oil concentrate, probiotics and some adaptogenic herbs. 

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