More than half of the Food and Drug Administration (FDA) Class I drug recalls between 2004 and 2012 were dietary supplements. This is according to a new study published in the online edition of JAMA Internal Medicine, which means certain supplements could really have put your wellbeing at stake. The ingredients in Class I drugs are likely to cause ‘serious adverse health consequences or death.’
According to the St. Michael’s Hospital research team, 237 (51%) of the 456 drugs subject to a Class I recall in the US between January 2004 and December 2012 were dietary supplements. Of these, the main supplements recalled fell under the categories of sexual enhancement, bodybuilding, and weight loss. However, sexual enhancement supplements were the biggest cause for wellness concern, accounting for 40% of all Class I recalls.
More than 150 million Americans consume dietary supplements, with 65,000 on the market to choose from. Unlike medicines, supplements do not require FDA approval before they can be sold, because they are defined differently. To the FDA, a dietary supplement is a product taken by mouth that contains a “dietary ingredient” such as vitamins, minerals, herbs, botanicals, or amino acids.
However, as these supplements do not require approval before hitting the shelves, this has paved the way for products manufactured in unsafe conditions or containing potentially dangerous ingredients (most notably, steroids). Study lead author Dr Ziv Harel, whose research focus is patient safety, commented that the FDA is required to contact the manufacturer to trace the source of the product and initiate a recall when the organisation learns of an adulterated dietary supplement. Yet, as a investigation by the Office of the Inspector General noted, the FDA lacks accurate contact information for 20% of supplement manufacturers.
For companies who want to fly under the radar, avoiding the FDA is relatively simple. All it takes is for you to change your company’s name or manufacturing locations, or make slight adjustments in product formulas. All of these measures throw agency investigations off course, and so the FDA has recently launched multinational enforcement groups and widespread media campaigns focusing on improving awareness, in order to close this gap. Yet Dr Harel said, ‘Despite these initiatives, products subject to Class I 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.’
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