FDA keeps enforcement on food label claims on a front burner: The commissioner says…
Environmentalists sue in California to keep PCBs out of fish oil supplements: According to the plaintiffs…
Consumers may get more than they want with some weight-loss products:The Los Angeles times reports…
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FDA keeps enforcement on food label claims on a front burner: FDA Commissioner Margaret Hamburg applauds food product firms for becoming more compliant with food labeling regs since she became commissioner in May 2009, but in a March 3 "Dear Industry" letter she says "we continue to see products marketed with labeling that violates established labeling standards."
Hamburg sent her letter the same day the agency published warning letters to 17 firms on 22 food product label violations, including some making drug claims and some with nutrient content claims on products for children under 2, which FDA regs prohibit
Hamburg's letter comes nine months after FDA, in her first month as commissioner, warned General Mills that label claims touting the clinically proven ability of Cheerios to lower one's cholesterol make the toasted whole grain oat cereal an unapproved new drug for treatment of hypercholesterolemia, as "The Tan Sheet" reported here.
We also reported on FDA's December 2009 warning letter to Nestle HealthCare Nutrition, questioning the "medical food" designation and related claims for Boost Kid Essentials Nutritionally Complete Drink.
The commissioner added that FDA soon will issue a draft guidance on front-of-pack calorie and nutrient labeling, a topic "The Tan Sheet" covered here. FDA also is planning to issue a draft guidance that would recommend nutritional criteria for foods with “dietary guidance” statements in their labeling.
While FDA more actively enforces on food labeling under the Obama administration, a former agency deputy commissioner, Scott Gottlieb, a physician and a resident fellow at the American Enterprise Institute, observes in a Wall Street Journal op-ed piece that FDA can help improve consumers' diets by allowing food firms to make more claims about "healthy benefits" their products provide.
Environmentalists sue in California to keep PCBs out of fish oil supplements: Environmental advocates and the Mateel Environmental Justice Foundation say something's fishy about some products in a rapidly growing supplement area -- omega-3 fish oil products.
In a lawsuit filed March 2 in state court in San Frnacisco, Chris Manthey and Benson Chiles, both of New Jersey, join Mateel in alleging fish oil capsules sold as health supplements for their omega-3 fatty acids content "have illegally undisclosed and unnecessarily high levels of contamination with polychlorinated biphenyl compounds."
The lawsuit names these firms as defendants: CVS Pharmacy Inc., General Nutrition Corp., Now Health Group Inc., Omega Protein Inc., Pharmavite LLC, Rite Aid Corp., Solgar, Inc. and TwinLab Corp.
The lawsuit alleges the firms' supplements have PCB contamination above the “safe harbor” limits set for human PCB consumption under California’s Proposition 65, which requires firms to include warnings about such exposures on their product labels.
The plaintiffs say Prop 65 "has a consistent history of forcing consumer products to eliminate toxic chemical ingredients" or reduce them below published accepted limits.
"What they want is for this entire industry to get serious about keeping PCBs out of fish oil supplements. We’ve shown the problem, and the law says it’s their responsibility to solve it – or else start warning their customers," a spokeswoman for the plaintiffs told "The Tan Sheet."
The Council for Responsible Nutrition, however, says the plaintiffs appear to be more serious about media attention than public safety concerns. CRN's scientific and regulatory affairs senior VP, Andrew Shao, said the plaintiffs are not specific about the PCB levels found in the fish oil products.
"Though the lawyers suggest that the levels of PCBs found in these products far exceed what is acceptable by Prop 65 standards, the actual levels of PCBs found in the majority of these products do not appear to exceed the Prop 65 limit" of 90 ng per day," Shao said in a CRN statement.
Further, the lawsuit fails to mention that FDA's tolerance level for PCBs in fish – 2,000 parts per billion – far exceeds the levels of PCBs found in fish oil, he said.
The suit likely was filed in California in order to take advantage of Prop 65's "conservative standards that are not law in the rest of the nation," Shao observed.
The Prop 65 allegation comes a month after FTC warned 11 marketers of children's omega-3 fatty acid supplements that the commission might take enforcement action if they could not substantiate adequately claims that their products can enhance the intelligence, mood and visual acuity of children older than 2 years, "The Tan Sheet" reported here.
Consumers may get more than they want with some weight-loss products: Some dietary supplements marketed for weight loss contain the hexavalent form of chromium that, in large doses, can lead to stomach ulcers, convulsions, kidney and liver damage and even death, the LA Times Booster Shots blog says, citing a ConsumerLab.com report.
California considers hexavalent chromium a carcinogen and wants to monitor the safety of the chemical in tis water supplies. According to Booster Shots, ConsumerLab.com found CCA Industries' Mega-T Green Tea, Natural Factors' Chromium GTF, and Chattem's Dexatrim Max contain quantities of hexavalent chromium beyond California's proposed safe daily "public health goal" of 0.12 mcg for drinking-water standards. Three other chromium-containing weight-loss products ConsumerLab.com tested did not show high levels of the ingredient.
(Elsevier Business Intelligence offers the latest and most in-depth analysis of the consumer health and persona care industries. Click here for a complimentary copy of "The Tan Sheet" and here for a copy of "The Rose Sheet.")
-- Malcolm Spicer (m.spicer@elsevier.com)
