FDA Issues Warnings on Weight Loss Products

WASHINGTON--On Nov. 1, the Food and Drug Administration (FDA) posted nine warning letters, dated Oct. 22, sent to marketers of several weight loss dietary supplements, questioning the veracity of the claims made for the products. The majority of the products were designed as carbohydrate blockers or blood sugar regulators, and contained ingredients including white bean extract (primarily labeled as Phase 2® from Pharmachem Laboratories), chromium picolinate and chitosan.

Manufacturers receiving warning letters included Bionutricals International, Cytodyne, Great Earth Co., Irwin Naturals, Nature's Sunshine and Reliant World Products; retailers included Getbuf.com, Tao of Herbs and Vitaminlab.com. Among the products targeted by FDA were CarboGetic, Xenadrine CarboCurb, Maximum Strength Phase 2® Carb Blocker and Carbo Grabbers®.

FDA's warning letters singled out structure/function claims it suggested were unsubstantiated and, as such, were misbranded. Claims included:

* "Blocks carb absorption via alpha-amylase inhibition."

* "Phaseolous Vulgaris (extract): is a starch blocker that has been clinically shown to neutralize up to 66 percent of the starch consumed in a meal."

* "helps reduce carbohydrate absorption in the foods you eat, and may also help reduce the amount of glucose derived from carbs and protein."

* "Phase 2 white kidney bean extract is the only material clinically proven to block starchy carbohydrates from turning into fat."

* "Helps reduce conversion of carbohydrates to calories."

* "Chromium picolinate - normalizes cravings."

* "Chitosan is a proven fat blocker."

Carb blocker supplements have attracted regulatory attention recently, particularly in the wake of ephedra's removal from the market. FDA issued several warning letters in April to companies marketing weight loss products using carb blocker claims, while FTC announced settlements in August with companies selling carb blocker and fat blocker products. The current warning letters are available online (www.accessdata.fda.gov/scripts/wlcfm/date.cfm?MONTH=10&YEAR=2004).

At press time, most calls to the companies that received the warning letters had not been returned. However, the claims in question had been removed from the Getbuf.com Web site and the Bionutricals International Web site. Spokesmen for Tao of Herbs and Vitaminlab.com each told HSR the company was working to update its Web site to address FDA's concerns.

Pharmachem Laboratories was working on a statement in response to HSR's request for comment. The company did direct HSR to a release posted in April 2004 on the Phase 2 Web site (www.phase2info.com), which discusses Pharmachem's policy on weight loss claims and Phase 2. In the release, Pharmachem noted it has invested heavily in clinical research to support the efficacy and safety claims it has made. In addition, Pharmachem requests marketers sign a license agreement for Phase 2 agreeing to make only claims that can be substantiated and use proper quantities of the ingredient in their finished products. Pharmachem's policy states the company has taken actions against marketers in violation of the agreement, including refusing to supply the ingredient and sending cautionary letters to companies out of compliance.

On the chromium side, Nutrition 21 noted companies that purchase its branded chromium picolinate, Chromax®, receive copies of published clinical data and recommend the companies review the science internally and have legal counsel review prospective label claims.