Economic Adulteration Regulators! Mount Up!

The Current Good Manufacturing Practices, which is enforced by the Food and Drug Administration, establish a set of rules that should keep companies from cutting corners in the hopes of saving a buck or two.

There shouldn't be a problem, right? Um, right?

Apparently not. In Dr. Margaret Hamburg's much-publicized open letterto supplement manufacturers last December, the FDA's commissioner of food and drugs sternly reminded manufacturers (even citing specific sections) of their responsibilities. Long story short, according to Hamburg, manufacturers must qualify suppliers, test incoming ingredients, and verify the content of finished products. Establishing guidelines for testing, specifying the components in a supplement, and precise record keeping are tantamount.

Bringing sham products to market carries risks. Depending on what FDA and the Department of Justice decide, says industry attorney Marc S. Ullman, firms could be prosecuted for fraud or for violating the Food and Drug Act

"In egregious [cases]," Ullman explains, "mainstream industry wouldn't mind seeing a prosecution."

The bottom line is that it's necessary to stay on FDA's good side. Aside from the guidance at trade associations and industry non-profits, resources abound to keep everyone in line.   

-- --The Council for Responsible Nutrition, and others in its working group, is polishing the Standardized Information on Dietary Ingredients (SIDI),a uniformset of guidelines on what kind of information should be requested—including ingredient origin and quality control measures—when a manufacturer deals with a raw materials supplier. 

Dr. Duffy MacKay, N.D., CRN's vice president, scientific and regulatory affairs, says the guidelines—some of which are in development—is currently at 12 chapters. A couple of chapters can be viewed here. But it is certainly a usable reference.

"When the FDA shows up at your door for GMP inspection, one of the key issues is, how do you qualify your supplier?" MacKay says. "The Voluntary Supplier Verification Guideline being developed by the SIDI Working Group is a way to satisfy that requirement."

--The American Botanical Council's white paper on industrial solvents is currently under peer review.

"There are a number of suppliers of extracts, particularly out of Asia, that are marketing various botanical extracts and natural food items, offering certificates of analysis that do not identify the actual solvent used in the extract they're representing nor the levels of those solvents" says ABC's founder and executive director Mark Blumenthal, who is giving a lecture on economic adulteration at May's SupplySide East.

Blumenthal added that ABC is developing another white paper (with a corresponding database) herbs that are adulterated due to economically motivation. Instead of gathering the usual suspects, ABC is conducting an "evidence-based review" with input from suppliers, manufacturers, and laboratories.

"The GMPs require manufacturers to test for the identity any herb or dietary ingredient that is known to be adulterated," Blumenthal says. "If there's evidence of adulteration, it must be tested."

--The U.S. Pharmacopeia (USP) is "the one-stop shop for quality specifications, testing methods, and references materials," says Dr. Markus Lipp, Ph.D., director, food standards, at USP.  "We offer the full sweep that anyone wants or needs to verify an ingredient," he adds.  Similar options: the National Institute of Standards and Technology, the American Herbal Pharmacopeia.

What more can be done to ensure that FDA isn't busting down the doors?