Recent months have witnessed a significant increase in the amount of dietary supplement products that are being permitted on retail store shelves that contain undisclosed and potentially dangerous ingredients; many of which have been found to be active pharmaceutical drugs. In light of the many transgressions occurring within the dietary supplement industry, officials at the U.S. Food and Drug Administration (FDA) have begun to crack-down on what appears to be an epidemic of fraudulent and unsafe business practices. In their latest response to such actions, officials at the FDA have issued two warning letters: One for alleged current Good Manufacturing Practice (cGMP) violations and the other for disease claims on ‘dietary supplement’ water.
According to the definition provided by congress in the Dietary Supplement Health and Education Act (DSHEA) of 1994, dietary supplements contain ingredients intended to supplement one’s diet. However, they are by no means permitted to make claims that directly affect the structure or function of a subsequent body part. “Dietary ingredients” contained within these products often include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites.
Unfortunately, however, recent years have witnessed an exponential increase in the amount of approved pharmaceutical ingredients being added to dietary supplements. “These products are masquerading as dietary supplements—they may look like dietary supplements, but they are not legal dietary supplements,” says Michael Levy, director of FDA’s Division of New Drugs and Labeling Compliance. “Some of these products contain hidden prescription ingredients at levels much higher than those found in an approved drug product and are dangerous.” The inclusion of undisclosed drugs may significantly increase the risk of adverse health effects. Reports received by the FDA acknowledge that these products may be associated with an increased risk of stroke, liver injury, kidney failure, heart palpitations, and death. As a result, many dietary supplement lawsuits have been filed in our courts.
One company that has recently been accused of adulterating their products is the Ohio-based Parrillo Performance. Following an FDA inspection of their supplement manufacturing and re-packing facility in February, officials were made aware of several violations. According to an FDA warning letter, the company was cited for “deviations from the Dietary Supplement regulations [that] cause your products to be adulterated […] in that the dietary supplements have been prepared, packaged or held under conditions that do not meet current good manufacturing practice regulations for dietary supplements.”
In response to the FDA warning letter, Parrillo Performance responded with a letter that addressed the corrective actions they have taken. However, officials at the FDA found their response to be unacceptable. “We received your response on March 21, 2012,” writes the FDA. “Your response states you are working on all items step by step and some of them items are already completed. We have reviewed your response and we find it inadequate because you have not provided any documentation to indicate that you have corrected any of the deficiencies observed during your inspection.”
Furthermore, officials working at the American Herbal Products Association (AHPA) noted in a legal alert that “Telling the FDA that you are fixing the problems is not enough.”
In continuing with their crack-down trend, the FDA issued a subsequent warning letter to Lithia Mineral Water after reports suggested that their dietary supplement water made false claims. According to the letter, the FDA has “determined that your “Lithia” product is being promoted for conditions that cause it to be a drug as defined by section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.”
As seen in another AHPA legal alert: “FDA notes that Lithia Mineral Water may have an identity problem since it is identified as a dietary supplement on the principal display panel, but it has a Nutrition Fact panel and describes itself as water and mineral water, which are foods.”
Do I Have a Dietary Supplement Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in dietary supplement lawsuits. We are currently accepting new cases in all 50 states.
If you or a loved one has been injured by a dietary supplement mentioned in this article you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-(949) 557-5800.