January 1, 1999

6 Min Read
Cholesterol-Buster  Status Clogged



Cholesterol-Buster
Status Clogged
January 1999 -- Regulatory Insight

  In one camp, food. In the other, dietary supplements. And never the twain shall meet. At least that's how FDA sees it. Now a new product that seemingly sets the two categories on a collision course is raising eyebrows with officials at that federal agency, who have declared it illegal.

  Despite recent manufacturer/FDA meetings, Benecol, a cholesterol-lowering product being made by McNeil Consumer Healthcare, Port Washington, PA, is still stalled at a federal roadblock. The product is available as a margarine in Finland, where it was introduced in November 1995 and reportedly enjoys healthy sales. McNeil officials hope to offer Benecol in regular and light-spread forms in U.S. grocery stores nationally in early 1999.

  "We object to the product being marketed as a dietary supplement," an FDA spokeswoman says, "but it certainly could be marketed as a food item." The agency is in continuing dialogue with McNeil, but nothing had been firmed up as of press time in mid-November.

  McNeil spokeswoman Amy Weiseman describes a Nov. 5 meeting in which the company submitted revised labels and new scientific information to FDA as "very productive."

  "We're still in discussion," Weiseman says. "We believe it's a dietary supplement. It's a dietary supplement in food form." McNeil officials say they've agreed to further discussions with FDA "as soon as possible to reach a conclusion leading to marketing of the product."

  FDA verifies that dialogue is continuing, but did not elaborate on details of the discussion. No additional meetings have been scheduled, an agency source says, and FDA officials were unable to verify that McNeil had made any changes to its intended Benecol labeling. In any event, it appears not to matter much at this point as FDA officials have not significantly changed their view of Benecol between the time they met with McNeil Oct. 16 and during the period following the latest meeting in November.

  In an Oct. 28 letter to Brian Perkins, president, McNeil Consumer Products Company, Joseph Levitt, director of FDA's Center for Food Safety and Applied Nutrition, details the agency's objections. "While labeled as a dietary supplement, (Benecol) bears label representations that establish the intent of this product to do more than supplement the diet," Levitt states. "The label for Benecol spread, through statements that the product replaces butter or margarine, vignettes picturing the product in common butter or margarine uses, statements promoting the flavor and texture of the product, and statements such as '...help(s) you manage your cholesterol naturally through the foods you eat,' represents this product for use as a conventional food."

  The Dietary Supplement Health and Education Act of 1994 defines the term "dietary supplement" to exclude products represented for use as conventional foods. It also distinguishes dietary supplements from conventional foods in several ways, including stipulating different requirements regarding safety, allowable claims and mandatory nutrition-label information.

  Also, the Federal Food, Drug and Cosmetic Act specifies that any substance added to conventional food has to be used according to a food-additive regulation unless considered to be Generally Recognized as Safe (GRAS). A substance whose intended use is GRAS doesn't require FDA premarket approval. However, FDA officials say McNeil's scientific advisors haven't made a GRAS determination concerning Benecol.

  "It appears that plant stanol esters are an unapproved food additive that may not be used in conventional foods," Levitt says. "Therefore, considered as a food, the Benecol spread is adulterated...and cannot legally be marketed in the United States."

  FDA officials have informed McNeil that the government knows other companies are marketing products similar to Benecol, warning that the agency will take "appropriate measures," including regulatory action, regarding these products. However, FDA officials would not reveal the names of these products or release the identities of the companies involved, saying they were not a matter of public record.

  Perhaps what is attracting particular attention to this case is that it is seen as possibly setting precedent "in terms of looking at dietary supplements in food form," Weiseman says. "It became more of a public issue than we expected," mainly due to FDA releasing its written dialogue with McNeil to the media.

  Results of studies involving Benecol offer promise for individuals battling cholesterol or attempting to keep it at safe levels. Last October, results of a Mayo Clinic study were released indicating that spreads containing Benecol's active ingredient, plant stanol esters, are able to cut LDL ("bad") cholesterol levels by as much as 14% if consumed regularly.

  Plant stanol esters inhibit transportation of cholesterol from the digestive tract to the liver, decreasing blood levels of total and LDL cholesterol, according to McNeil. The plant equivalent of cholesterol, stanols are present in wood and vegetable oils. They're also contained in corn, wheat, rye, oats and olive oil.

  In another study, published in the Nov. 16, 1995, issue of The New England Journal of Medicine, researchers in Finland determined that plant stanol esters lowered cholesterol in individuals during a one-year period by roughly 10%, while a control group not given the substance experienced a 0.1% jump in cholesterol levels. Researchers also say that soluble sistanol (a type of plant sterol) might prove more effective than a less-soluble version.

  In both the Finnish and Mayo Clinic studies, researchers determined that the substance was "well-tolerated" by test subjects.

  McNeil gained exclusive North American marketing rights to stanol esters in July 1997.

  

Each Benecol margarine carton will contain approximately 21 single-serve pad portions, each measuring roughly one-half teaspoon (8 grams by net weight). It is recommended that individuals consume three units daily to obtain the cholesterol-lowering benefit, Weiseman says. McNeil proposes to follow up with salad-dressing forms and other products utilizing Benecol.

New FDA Chief Sets Agenda

  Implementing the FDA Modernization Act resides at the top of the list of priorities that Jane Henney, M.D., plans to tackle in her new post as FDA commissioner. Henney, the first woman to hold the position, also plans "to strengthen the agency's scientific base to ensure the best science guides the critical decisions that need to be made."

  "I look forward to rejoining the agency and bringing my full energy and enthusiasm to the important challenges that the coming months and years will bring," says Henney, who served as FDA deputy commissioner from 1992 to 1994.

  The 51-year-old cancer specialist has served as vice president for health sciences at the University of New Mexico, Albuquerque, since 1994.

  The National Food Processors Association (NFPA), Washington, D.C., has been supportive of Henney since her nomination last summer.

  "We urge that food issues - and support for the agency's Center for Food Safety and Applied Nutrition - are areas of emphasis for the new commissioner," says NFPA President and CEO John Cady. "FDA must have a strong food focus, and it is imperative that FDA and the food industry continue to work together toward sound, science-based policy and regulatory decisions."

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