Last month, vitamin supplement manufacturer Doctor’s Best voluntarily recalled more than 7,300 bottles of its “Best Red Yeast Rice” supplement, following FDA’s discovery that the capsules contained lovastatin, an undeclared cholesterol-lowering agent.
Lovastatin is an approved drug recommended for the treatment of high cholesterol belonging to the class of drugs called “statins.” In rare cases, the product, marketed as a heart health supplement, has been found to potentially cause severe muscle injury in consumers who use it regularly. The health risks are highest in pregnant women and patients who are already taking prescription medication containing statins such as lovastatin, atorvastatin (known as Lipitor), or simvastatin (known as Zocor).
Doctor’s Best’s supplement is the last of a long series of dietary supplements recalled by the FDA over the last decade. According to a study published by the JAMA Internal Medicine, there were 465 Class I drugs recalled in the U.S. between 2004 and 2012, and dietary supplements accounted for more than half (237). The “Class I” designation is given to products containing ingredients that could cause severe adverse health consequences and even death. Researchers have reason to believe that another 110 supplements containing unlisted drugs were not removed from the marketplace and continue to be distributed nationwide.
The Inexplicable Love for Vitamins & Supplements
Despite startling reports of undeclared allergens, mislabeling, presence of contaminants, and incorrect potency, Americans take their vitamins religiously.
The third annual survey from the Vitamin Shoppe, Inc. revealed that 64 percent of Americans currently take a vitamin or dietary supplement, making the nutritional supplement group one of the fastest growing industries in the country. In 2012, sales totaled nearly $23 billion, and, according to Euromonitor International, they are growing at a 5% to 7% annual rate. However, industry assessments that also look at the labor, technology, and materials that go into the production of supplements believe the industry is contributing more than $60 billion to the national economy. Overall, condition-specific products are doing especially well, including digestive supplements, Omega-3s (marketed as heart health supplements), joint health supplements, and energy supplements.
Despite the lack of credible evidence to back their claims, an even higher number of Americans (85%) are confident in the safety, effectiveness, and quality of these products. Industry surveys show that bodybuilders and “weekend warriors” are no longer the only target audience of supplement manufacturers, as they were a decade ago. Now vitamins, minerals, herbals, and supplements appeal to everyone in search for quick health remedies: 34% are used by adults ages 20-39, 50% by ages 40-59, and 67% by age 60+.
The Supplement-Rich Diet: Doing More Harm than Good?
Unfortunately, the fact that they have gone mainstream didn’t necessarily impact their safety and effectiveness. In fact, supplements have the least U.S. regulatory oversight compared to consumer products and over-the-counter drugs, being treated more like special foods than drugs. Most people take the so-called natural supplements because they consider them safer – and more effective – than drugs, when in reality, their safety has been challenged many times, with sexual enhancement, bodybuilding, and weight loss supplements topping the list of drugs with highest number of recalls.
Unlike the highly-regulated prescription drugs that have to adhere to strict regulations to receive FDA approval, “botanicals” don’t need to be deemed safe or effective by the FDA before they can be sold. They are considered safe until proven otherwise, so manufacturers are not required to finance clinical trials to test new ingredients and supplements. The only rules they need to follow – and these were only introduced in 2007 – are certain vague guidelines regarding their purity, potency, and manufacturing process.
Fortunately, the FDA is interested in mitigating the impact and spread of adulterated supplements and has recently introduced several initiatives, including media campaigns designed to raise awareness and the creation of multinational enforcement groups. But until these measures will be able to address all problematic situations that put the public’s well-being in danger, it’s up to us to make sure we know what we’re swallowing.
About the Author
Attorney Jeff Luhrsen credits his military career with the work ethic, integrity, and tenacity that drives his career as a personal injury attorney. Having garnered numerous academic awards and scholarships during college and law school, Mr. Luhrsen has continued to earn accolades throughout his career, including a Martindale-Hubbell AV® Preeminent™ Peer Review Rating, the highest rating an attorney can achieve in legal ability and ethical standards. He has been in private practice since 1998 with a focus on tort claims and insurance disputes. Luhrsen Law Group, based in Sarasota, Florida, is proud to be a family-owned firm that helps Florida families recover after serious injuries and from legal wrongs.
Jeff Luhrsen 