Friday, April 8, 2011

FDA and Product Warnings

I am no fan of the FDA. The FDA Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4th, 2011. It seems pretty hypocritical to me to get more involved than ever before in the food industry, yet prescription drugs are marketed after minimal trial periods on a fast track plan. However, I really don’t have a dog in this fight (yet). I have been asked by groups to lend my support against the FSMA, particularly for nutritional supplement manufacturers, who fear further government regulation will drive their manufacturing and product prices up and their profits down. Probably true. But I have partnered with one of the few nutritional supplements manufacturers who use voluntary pharmaceutical grade Good Manufacturing Practices, ensuring that their products are pure, potent, have proper dissolution and are bio-available. So we are already under the highest standards.

Having said that, I think there is a place for the FDA and especially in the area of safety with product re-calls. The FDA has created a new page on their web site for the re-call and safety notifications of foods, drugs and supplements. This is not the re-classification page, but it does contains safety alerts and re-calls for foods, drugs and supplements issued within the last 60 days.

Go here.

One of the FDA Press Releases will look like this:

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Shaping Beauty, Inc. Issues a Voluntary Nationwide Recall of Weight Loss Tea Found to Contain an Undeclared Drug Ingredient

FOR IMMEDIATE RELEASE - March 15, 2011 - Southampton, PA, Shaping Beauty, Inc. has been informed by the Food and Drug Administration (FDA) that a weight loss dietary supplement sold and marketed by the firm contain an undeclared drug ingredient. FDA lab analyses of dietary supplement tea distributed by the company were found to contain undeclared Sibutramine used as an appetite suppressant for weight loss. The FDA has not approved the following products as drugs; therefore the safety and effectiveness of this product is unknown. All lots of the following dietary supplement products are being recalled: CELERITETM SLIMMING TEA

The products listed above were sold and distributed nationwide via the internet at www.shapingbeauty.com1

FDA advises that these products pose a threat to consumers because Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

I hope people will bookmark and use this site from time to time to check on safety notices from the diverse products being consumed that are not manufactured in a safe manner.

For Information on the Products I recommend, click here, to contact me.

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