Science Magazine Article Calls for Supplements Regulation

CHAPEL HILL, NC—In a move that some supplements industry observers say is well-intended but misguided, University of North Carolina School of Public Health Professor Steven Zeisel, in an article in the September issue of Science magazine, has called for the regulation of nutraceuticals.

Zeisel, who is chairman of the school’s nutrition department, defines nutraceuticals as dietary supplements that contain a concentrated amount of a presumed bioactive agent derived from a food and that are delivered in a nonfood form. Because these products can have drug-like effects, Zeisel says they should be regulated, if not like drugs, then as something other than foods.

While foods are presumed safe because of their history of exposure, nutraceuticals allow ingredients to be consumed in dosages far greater than in a normal diet. Because of this, Zeisel asserts, manufacturers should prove their products are safe before they are allowed on the market.

Zeisel says the 1994 Dietary Supplement Health and Education Act (DSHEA) modified the regulatory environment so that it is possible and even likely that products will be marketed that inadvertently harm people. He points to a few instances when the FDA asked for a voluntary recall or

regulation only after a product showed serious side effects.

Industry insiders seem to think Zeisel is well-intentioned but ill-informed, especially in his failure to report the industry’s position on regulation. “We share his concerns,” says Loren Israelsen, president of Salt Lake City-based natural products consulting firm LDI Group. “Other than a few factual errors, Dr. Zeisel quite rightly calls for regulations. What he doesn’t recognize is that we as an industry have been asking for regulation for 10 years. FDA is not interested in regulation.”

John Hatchcock, VP of the Washington-based Council for Responsible Nutrition (CRN), says parts of Zeisel’s article lacked information and showed bias. “Many substances enter the maketplace through use in conventional foods as self-declared GRAS [generally recognized as safe] ingredients,” Hatchcock says. “That is, a company can assemble the data on an ingredient, have it reviewed by appropriate scientists and notify FDA that they consider the ingredient to be GRAS. FDA can disagree and take action, but no approval by FDA is required.”

Zeisel calls for the adoption of Good Manufacturing Practices (GMPs) but never mentions that many of the major supplements suppliers welcome GMPs. “CRN agrees that FDA should develop GMPs for dietary supplements and has petitioned FDA to do so,” Hatchcock says.

Zeisel asserts that stricter regulation would be good for the public and good for the dietary supplements industry. Regulation could help avoid a potentially devastating public relations problem should a supplement ever harm a large number of people.

Israelsen says this is precisely why so many in the industry support regulation. He says many companies would welcome a new standard that provides some sort of government approval for the safety of their products.