In May the FDA (Food and Drug Administration) sent a warning letter to General Mills, the manufacturers of Cheerios indicating that they had found “serious violations of the Federal Food, Drug, and Cosmetic Act” in that they believe based on the packaging that Cheerios was “is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease.”
According to the Warning Letter sent by the FDA to Cheerios they were accusing General Mills of marketing an “Unproved New Drug”
Based on claims made on your product’s label, we have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease. Specifically, your Cheerios® product bears the following claims on its label:
- “you can Lower Your Cholesterol 4% in 6 weeks”
- “Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is … clinically proven to lower cholesterol. A clinical study showed that eating two 1 1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol.”
These claims indicate that Cheerios® is intended for use in lowering cholesterol, and therefore in preventing, mitigating, and treating the disease hypercholesterolemia.
Cheerios packaging has changed a lot over the years. As seen in the photo above, the claims on the packaging are that Cheerios are “Clinically Proven to Help Reduce Cholesterol.” It looks with the latest boxes on the shelves that Cheerios has removed the claims of lowering your cholesterol 4% in 6 weeks.
I think that the FDA was correct in pointing out that General Mills has crossed a line in it’s packaging and marketing of Cheerios, using language that is usually used when discussing drugs.
With that said, Cheerios has been a staple in our house since the girls were young, because it is one of the few cereals out there with low fat, low sugar, high fiber and healthy benefits from oats.
Sources:
FDA. May 5, 2009. General Mills, Inc. 5/5/09. Warning Letters.
FDA. May 14, 2009. Labeling of Cheerios® Toasted Whole Grain Oat Cereal Q’s & A’s Regarding FDA’s Warning Letter. Resources for You > Consumers.
June 15th, 2009
The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist.
Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products.
Linda Katz, M.D.
Interim Chief Medical Officer
FDA’s Center for Food Safety and Applied Nutrition.
I saw an ad for Hydroxycut in a magazine this morning and was wondering about the safety and claims made by the product. Another one of those…”looks too good to be true” and “buyer be ware.” I guess it was only been a matter of time that something would come up.
Today the FDA (Food and Drug Administration) issued an official release warning consumers to immediately stop using Hydroxycut products. To date the FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. In addition one death due to liver failure has been reported to the FDA.
About Hydroxycut Products
Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names. The products are prodiced by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y.
Return Products to Place of Purchase
Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.
List of Hydroxycut Products being Recalled:
The list of products being recalled by Iovate currently includes:
Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural
More on Dietary Supplements
For more information on Dietary Supplements, see the page on FDA 101: Dietary Supplements.
Sources:
FDA. May 1, 2009. FDA Warns Consumers to Stop Using Hydroxycut Products. FDA News.
FDA. May 1, 2009. Hydroxycut Products. FDA Products.
May 1st, 2009
On August 22, 2008, the Food and Drug Administration (FDA) published a final rule that allows the use of irradiation to make fresh iceberg lettuce and fresh spinach safer and last longer without spoiling.
The FDA ruling allows spinach and lettuce sellers to take an extra step, a long-awaited move amid increasing illness outbreaks caused by raw produce.
Irradiation has been shown to kill E. coli, salmonella and listeria and lengthen shelf life, without compromising the safety, texture or nutrient value of raw spinach and iceberg lettuce.
The FDA is reassuring the public that the process will not make food any less appealing or less healthful than non-irradiated varieties.
For More information see the FDA’s website or download a Printer-Friendly PDF File.
Sources:
FDA. Irradiation: A Safe Measure for Safer Iceberg Lettuce and Spinach. Also Image Source.
Associated Press. August 22, 2008. FDA approves irradiating spinach, lettuce to kill germs. LA Times.
Associated Press. August 21, 2008. FDA: Irradiated spinach, lettuce OK to kill germs.
September 3rd, 2008
