Dietary Supplements are not, and don't have to be, approved by the FDA.

05/04/2009 | Products Liability

One of the fundamental problems with most diet supplements is that they don't have to go through a Federal Drug Administration approval process.  There are simply too many diet supplements on the market for the FDA to test, approve and monitor all of them.  This leads to a lot of products we put in our bodies being untested by any meaningful organization to ensure they aren't harmful.

Because the FDA isn't involved in the process on the front end, the best they can do is to ask that products be pulled on the back end, once there is a question about safety.  That's exactly what happened this past week went the FDA warned consumers to STOP using the popular diet and energy supplement Hydroxycut. 

You can see an Associated Press video of the recall here: 

"The Food and Drug Administration said the company that makes the dietary supplement has agreed to recall 14 Hydroxycut products. Available in grocery stores and pharmacies, Hydroxycut is advertised as made from natural ingredients. At least 9 million packages were sold last year, the FDA said.   Dr. Linda Katz of the FDA's food and nutrition division said the agency has received 23 reports of liver problems, including the death of a 19-year-old boy living in the Southwest. The teenager died in 2007, and the death was reported to the FDA this March. Other patients experienced symptoms ranging from jaundice, or yellowing of the skin, to liver failure. One received a transplant and another was placed on a list to await a new liver. The patients were otherwise healthy and their symptoms began after they started using Hydroxycut."  Katz went on to say "Part of the problem is that the FDA looks at dietary supplements from a post-market perspective, and an isolated incident is often difficult to follow."  Public health researcher Ano Lobb, who has studied Hydroxycut and other dietary supplements for Consumer Reports, said "You really have to be careful about dietary supplements, especially weight-loss pills. People believe that the FDA has verified that these products are at least safe and effective, and that's really not the case. When you see fantastic claims _ that's generally what they are."

The recall covers the following 14 products:

The following products are covered by this voluntary recall:


I predict this will lead to mulitple lawsuits over the safety of the diet supplement for people who have possibly been injured as a result of using it.  These lawsuits will likely be filed as a class action or, perhaps, individual lawsuits will be combined in  a multidistrict litigation (MDL).  A second kind of lawsuit will likely be filed for those consumers that weren't physically injured but who purchased an unsafe product and will not use any remaining product because of the recall.  These consumer's are entitled to receive the purchase price returned becuase these sales likely violate various state's consumer protection laws.  These claims can be brought by individuals or, perhaps, by states' Attorneys General.

I predict that hundreds if not thousands of lawsuits will be brought by users of Hydroxycut against the Canadian company lovate Health Sciences USA Inc.

If you want more information on the recall or your rights, feel free to contact us.

hans