If your company based in California sells products or supplements designed to improve the health of people afflicted with chronic health conditions, you may come under increased scrutiny by the United States federal government. Last fall, the Food and Drug Administration (FDA) sent warning letters to 10 companies they accused of illegally selling dietary supplements that claim to treat diabetes. Could your company be next?
Dietary supplements cannot claim treatment properties
Although many people regularly use dietary supplements because they feel these aids help them cope with medical conditions, the companies manufacturing these supplements cannot make medical claims about them. To do so under current law constitutes pharmaceutical fraud. The FDA claims that the ten companies in question made claims about their supplements, saying that they treated or prevented diabetes, possibly preventing patients from seeking proven drug therapies. The agency believes that using these supplements could put some consumers at medical risk.
Unlike drugs manufactured by pharmaceutical companies, the FDA does not evaluate supplements for their intended use and efficacy, proper dosing, how they could interact with various medications and supplements and whether there are any dangerous side effects. Most supplement manufacturers cite anecdotal evidence and third-party lab evaluations to back their products.
What if my company receives a warning?
If the FDA sends you a letter regarding your company’s claims about supplements it produces, you must address their concerns or provide reasoning or supporting information on why your products are not violating the law. Not doing so could result in civil litigation against you, particularly if claims begin to arise from product usage.
Making sure that your products are legal is crucial to your livelihood. Violations of pharmaceutical law can result in stiff fines, penalties, jail time and even the shuttering of your company if you are found guilty.