Drug Recalls are A Wake Up Call for Vitamin & Supplement Industry

 Posted on May 27,2013 in Drugs

According to a recent article published by Forbes, it has been discovered that dietary supplements have made up over half of all FDA Class 1 drug recalls between 2004 and 2012. “Class 1” means that the supplements contained ingredients that have a potential to “cause serious adverse health consequences or death.”

The St. Michael's Hospital research team determined that between January 2004 and December 2012, 51% of drugs subjected to a Class 1 recall were in fact dietary supplements. Most of these recalls took place after 2008 for what was said to be unknown reasons.

The categories of supplements with the highest recalls were developed for (1) sexual enhancement, (2) bodybuilding, and (3) weight loss. Sexual enhancement supplements accounted for 40% of all Class 1 recalls.

What makes the supplement industry unique is that they do not require FDA approval before being sold. There are currently approximately 65,000 dietary supplements on the market in the United States.

However, this enables supplements that are manufactured in other countries to find their way into the stores and homes of American citizens. Sometimes these products are manufactured under unsafe conditions. They can also potentially contain ingredients that fall under the FDA's “Class 1” category.

According to the study's lead author, Dr. Ziv Harel, when the FDA learns of a dangerous dietary supplement, it is required to trace its source and put a recall into place. A recent investigation, however, has exposed that the FDA does not possess accurate contact information for about 20% of supplement manufacturers.

The issues arise because the many companies manufacturing supplements around the world are always one step ahead of the game. It is very easy for them to change company names, locations, or make slight adjustments in product formulas. All of these things throw the agency off course.

Recently, the FDA has taken measures in order to mitigate the impact of these supplement ingredients. However, Dr. Harel said that these steps are not getting the job done. “Despite these initiatives, products subject to Class 1 recalls continue to be readily available for sale, which may be due to an increasingly complex distribution network associated with these products, as well as ineffective communication by the FDA to consumers.”

It is true that many manufacturers are aware that even though their products do not necessarily need to earn FDA approval, they will face penalties if they market dangerous ingredients or make absolute assertions about what a supplement will do for the consumer.

While supplement companies are a huge fraction of recalled drugs, they are also trying to improve their tactics. However, if you have been affected by recalled supplements you should contact a dedicated defective medical attorney immediately.