AHPA: Synthetic Botanicals Are Dietary Ingredients

SALT LAKE CITYMany botanical manufactures fear the new dietary ingredient (NDI) Draft Guidance from FDA says their synthetic ingredients arent even dietary ingredients (DIs), let alone NDIs, and thus cannot be legally added to supplements unless they achieve food additive status. However, Michael McGuffin, president, the American Herbal Products Association (AHPA), said this may not be the case per theDietary Supplement and Health Education Act of 1994 (DSHEA) during the United natural Products Alliances (UNPA) two-day event on the FDAs NDI Draft Guidance.

McGuffin, who focused on herbs for his presentation, said FDA provided a useful NDI decision tree where companies can determine if an NDI is needed based on a few questions:

1.       Is it a dietary ingredient (DI)?

Per DSHEA, McGuffin said herbal DIs are defined as: a) a concentrate, metabolite or combination of herbs; b) a naturally occurring constituent, but NOT a synthetic constituent; or c) an extract, irrespective of solvent. Regarding synthetic botanical ingredients, he said they can be considered DI under section (ff)(1)(E), which says an ingredient can be defined as a dietary substance for use by man to supplement the diet by increasing the total dietary intake."

2.       Is it new?

As outlined in DSHEA, old dietary ingredients (ODIs) were those marketed before Oct. 15, 1994, and do no require a notification. However, McGuffin took issue with FDAs stance that there is no authoritative list of ODIs. He said AHPA published Herbs of Commerce" in 1992, which was incorporated into a Code of Federal Regulations (CFR). While McGUffin said Herbs of Commerce" is not an exhaustive list, it does provide a list of herbs that were in the market in 1992.

3.       Is notification required?

McGuffin noted any herbal NDI required a notification unless its manufacturing process has not caused it to be chemically altered from an ODI or if the DI has been affirmed GRAS.

4.       What information should be submitted in an NDI notification?

McGuffin said Latin name, plant part, voucher specimen, harvesting conditions, geographic origins and controls for toxins should be included. Safety information should also be included in the notification.

McGuffin also offered a summary of FDA responses to NDI notifications since 1994. He said as of February 2010, 547 NDIs had been submitted, only 64 of which were for finished products. Of the 483 ingredients that were submitted as NDIs, 112 were resubmitted after FDAs initial review, leaving 361 unique ingredient NDI notifications. Of those 361, McGuffin said 15 were withdrawn by the company. This leaves, according to McGuffin, 346 unique NDI ingredient notifications. Of these, FDA did not object to 47 of them on initial submission, FDA did not object after resubmission of 34 of them, and FDA issued objections to 224.

He also walked the audience thorough a few of the notifications from submission to objection to resubmission. He noted, The Cost of doing NDI isnt $.44. You are going to have a cost involved. Theres a cost to supporting science." He said the cost can range from $12,000 to $30,000 at the low end.