Our products liability attorneys have long advised those who take dietary supplements to do so with care. Now, a review of years of federal inspections of the manufacturers of these supplements – from vitamins and multivitamins to herbal supplement and protein powders – has confirmed that problems in formulation and manufacturing are even more widespread than previously believed.
The supplement industry is now producing $28 billion annually. Approximately half of all Americans use such supplements, in one form or another.
But in only the past four years the federal Food and Drug Administration, which conducted 450 inspections in that time period, found violations of rules governing supplement manufacturing in half the companies inspected. And this year, the rate of violations is even higher, with two-thirds of the companies inspected engaged in violations.
Some of the common violations found by the FDA include a failure to verify the identity of ingredients being used, the failure to inspect completed products, and even the failure to have an established recipe for the products being produced – or substituting ingredients without altering the product labels.
Other violations found are symptomatic of the manufacturing and food industries as a whole, such as manufacturing products under unsanitary conditions. The FDA found factories with rodent infestations, and covered in rodent waste (urine and feces). The FDA even found dead rodents next to manufacturing equipment.
In one out of every four inspections, the violations found were severe enough to warrant an FDA warning letter. This year, that number has risen to one out of every three inspections. In some cases, the agency has taken legal action against the companies for failure to correct manufacturing problems.
This four-year period represents the entire period during which FDA inspections have taken place. Inspections of the supplement industry began in 2008, when the agency first imposed regulation on manufacturing in this industry.
The industry has defended itself by claiming that there has not yet been sufficient time to bring manufacturing into compliance with the new rules. However, the final regulations were available in 2007, leaving companies ample time to comply. This argument is also belied by the fact that violation rates have risen this year, five years after the rules were issued. The industry also asserts that it takes time to learn how the FDA will enforce its new rules – an argument which we find particularly troubling. This suggests that the industry is hoping to learn enforcement practices in order to evade citations, not to bring its plants into actual compliance.
These violations are not merely academic. For example, in 2008 over 200 people were poisoned in a single incident of selenium overuse in a liquid multivitamin. Victims lost their hair and nails, experienced memory loss and congnitive problems, physical disability, and weakness. Indeed, independent consumer groups have found that one out of every four dietary supplements on the shelf of U.S. stores has a significant problem, such as radically more or less of an ingredient than is listed, contamination with feces or heavy metals, or decay and rancidness. There was no difference in this rate between smaller, independent companies and large commercial vitamin manufacturers.
These manufacturers have faced agency action and legal actions – yet have shown little willingness to comply. In the case of one rodent-infested plant, the manufacturer was ordered by the FDA to cease operations at the facility, and meet cleanliness standards before reopening. Instead, the company moved operations to another plant in the area, even going so far as to shuttle workers to the new facility. These actions resulted in criminal contempt convictions for the plant’s owners and managers.
Again, we encourage our readers to use supplements with extreme caution. Most importantly, if you experience problems after using a new supplement – or even a new bottle of a trusted supplement – stop using it immediately, keep the remaining contents of the bottle, and see your doctor as soon as possible. If you have questions about your legal options after suffering side effects or medical problems from a supplement, contact an experienced attorney.
For a free consultation with an experienced Chicago injury attorney at Passen & Powell, call us at (312) 527-4500.
