FDA finds dangerous levels of chromium in certain flavors of Total Body products
ROCKVILLE, Md. The Food and Drug Administration reported Thursday that its final analysis of certain flavors of “Total Body Formula” and “Total Body Mega Formula” has detected hazardous amounts of chromium.
On April 9, the FDA reported the dietary supplement products contained hazardous amounts of selenium in samples of “Total Body Formula” in Tropical Orange and Peach Nectar flavors and “Total Body Mega Formula” in the Orange/Tangerine flavor. Further FDA analysis of the products found high levels of chromium as well. The samples contained up to 3,426 micrograms of chromium for the recommended serving (17 times the recommended intake). The recommended chromium intake for an adult ranges from 35 to 45 micrograms per day.
Excessive consumption of chromium can cause fatigue, muscle cramps, hyperactivity, hypoglycemia, renal failure and liver toxicity. Excessive chromium intake also can interfere with certain medications.
The new FDA finding comes as the U.S. Centers for Disease Control and Prevention reports that the number of confirmed cases of adverse reactions in consumers using the products has climbed to at least 201 individuals in Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, Texas and Virginia.
Consumers were first cautioned March 27, 2008 not to purchase and to discontinue the use of “Total Body Formula” in Tropical Orange and Peach Nectar flavors and “Total Body Mega Formula” in the Orange/Tangerine flavor after receiving reports of adverse reactions.
The FDA is continuing to investigate how excessive amounts of selenium and chromium got into the products.
The sole distributor of the “Total Body Formula” and “Total Body Mega Formula” products has voluntarily recalled the affected products.
Consumers who have been taking the products and have experienced adverse reactions should consult their health care professional. Consumers and health care professionals are encouraged to report adverse events to the FDA’s MedWatch program at 1-800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.
Web-based association regulates weight-loss claims
NEW YORK One week after a number of weight-loss advocacy groups and GlaxoSmithKline petitioned the Food and Drug Administration to closely regulate weight loss claims, an Internet industry association noted that it’s already reining in what it considers to be outlandish advertising claims through a self-regulation program of online advertising.
The Electronic Retailing Association created the self-regulation tool, the Electronic Retailing Self-Regulation Program, which is administered by the Council of Better Business Bureaus and overseen by the National Advertising Review Council.
The ERSP on Monday determined that Proactol, marketer of the Proactol Fat Binder, has provided a reasonable basis for certain advertising claims and announced that the company has agreed to modify other claims.
ERSP reviewed advertising claims in Internet advertising, in videos posted to the YouTube video-sharing Website, and on a MySpace Website page for the product. Claims at issue included: “Helps Decrease Your Appetite;” “Proactol has been clinically tested to bind up to 28 percent of dietary fats;” and “Medically Backed Weight Loss.”
ERSP determined that the marketer provided a reasonable basis for its general performance claims that Proactol “helps reduce” calorie intake, excess body weight, food cravings and appetite, but recommended that any representations regarding weight loss be properly qualified by indicating that the product should be used in conjunction with a low-calorie diet and a routine exercise regimen.
Proactol informed ERSP that it has removed claims from the US version of its Website and product labeling stating that the product is “clinically proven” in favor of the modified claim “clinically tested.” Further, the marketer asserted it has removed from its U.S. Website the claim that it is a “certified organic medical device.”
Following its review of the evidence, ERSP determined the marketer provided a reasonable basis that the product’s active ingredient—a fiber complex—has been “clinically tested.” However, ERSP recommended the marketer discontinue use of the claim in instances where it makes specific, quantified reference to the product’s effectiveness, to avoid suggesting to consumers that the product is “clinically proven” to effect dietary fat intake.
ERSP also determined that the statements of the two doctors read in conjunction with the general comments about the clinical testing conducted on Proactol provided a reasonable basis for the claim that the product is “medically backed.”
Further, ERSP confirmed that the claim that Proactol “Is a certified organic medical device” no longer appears on the U.S. version of the Proactol Website.
In its decision, ERSP noted that it has been advised that the marketer has had videos containing inaccurate claims removed from the Internet. ERSP has alerted the marketer to other third-party advertisements containing unsupported and/or inaccurate claims and requested the marketer use its best efforts to address these advertisements as well.
The company, in its marketer’s statement, said “Proactol has fully supported the ERSP self regulatory program’s inquiry and has appreciated the professionalism shown throughout this investigation” and “Proactol Ltd will ardently try to adhere to the comments and suggestions made within this inquiry.”
CRN opposes petition to FDA on weight-loss claims
WASHINGTON The Council for Responsible Nutrition stands opposed to the joint citizens petition filed April 17 by the American Dietetic Association, the Obesity Society, Shaping America’s Health and GlaxoSmithKline Consumer Healthcare, which asks the Food and Drug Administration to treat weight-loss claims for dietary supplements as disease claims, the association stated Monday.
“CRN plans to oppose this petition to re-classify weight loss claims as either disease claims or health claims requiring FDA approval,” stated Steve Mister, president and chief executive officer of CRN. “We believe weight loss claims are legitimate and appropriate claims for products in the dietary supplement category, provided these products have substantiation to support the truthfulness of these claims. FDA has made it clear that it considers weight loss claims appropriate and permissible under the Dietary Supplement Health & Education Act—meaning that manufacturers should not have to seek the Agency’s approval before making these claims. Therefore, CRN intends to vigorously defend the industry’s rights in this area.”