Drug recall lawyers at Pintas & Mullins highlight a recent study which found that, between 2004 and 2012, dietary supplements made up more than half of all FDA Class I drug recalls. "Class I" refers to recalls of drugs that have a reasonable probability of causing serious health consequences or death.
The study was published in JAMA Internal Medicine, and begins by noting that the FDA recently identified an emerging trend in which dietary supplements are being manufactured with hidden and potentially harmful hidden ingredients. Dietary supplements are defined as products taken orally that contain dietary ingredients meant to supplement the diet. This can refer to anything from vitamins and herbs to weight-loss pills.
Unlike pharmaceuticals, federal law does not require dietary supplements to undergo grueling review before they are sold and advertised. The government does, however, require these manufacturers to use good practices to ensure quality, and test some drugs post-market . Despite this, thousands of dietary supplements are released onto U.S. markets each year contaminated with undeclared pharmaceutical compounds, exposing consumers to harmful and dangerous side effects.
In the eight years studied, 465 drugs caused a Class I recall, and 51% of those were dietary supplements. The three types of supplements with the highest amount of recalls were: sexual enhancement, body building, and weight loss. Sexual enhancement supplements had by far the most, making up 40% of all Class I recalls.
Some of the most recent recalls were for sexual enhancement drugs Vicerex and Black Ant, which are both manufactured by American Lifestyle. Vicerex was discovered to have the drug tadalafil (generic for Cialis) in its ingredients, and Black Ant was found to contain sildenafil (generic for Viagra). Both of these undeclared drugs can cause dangerously low blood pressure among other adverse health effects.
There are about 65,000 dietary supplements currently on American markets, many of which were manufactured abroad. There is an enormous network of supplement manufacturers around the world, the majority of which always seems to be one step ahead of regulatory detection. Once a drug is found to have adulterated substances, standard procedure requires the FDA to contact the manufacturer to trace the contamination and initiate the recall. A recent investigation, however, revealed that the FDA does not possess accurate contact information for about 20% of manufacturers.
In response, the FDA recently initiated a widespread media campaign and created enforcement groups in numerous nations to help improve and spread awareness of this issue. Despite these measures, however, drugs subject to Class I recalls continue to be sold and consumed.