Fraudulent practices continuously exhibited by dietary supplement manufacturers, in recent months, have caused consumers to question the safety and effectiveness of products in the industry. Subsequently, an influx of dietary supplement manufacturers have begun to manipulate their products, so as to avoid strict regulations set forth by the U.S. Food and Drug Administration (FDA). Among those accused of adulterating their products, Syntec Inc. recently had all of their dietary supplements seized by U.S. Marshals because of false claims made about their safety and effectiveness in regards to treating several diseases.
Congress defined the term “dietary supplement” in the Dietary Supplement Health and Education Act (DSHEA) of 1994. As the name suggests, a dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites.
According to a recent lawsuit filed against the drug manufacturer, on behalf of the U.S. government, products distributed by Syntec Inc. were not approved by the FDA to be marketed as dietary supplements. Their implications resemble those of drugs. Furthermore, a complaint filed in the United States District Court for the Western District of Wisconsin alleges that several Syntec Inc. products are unapproved new drugs that may not be introduced into the U.S. market and are misbranded in violation of the Federal Food, Drug, and Cosmetic Act. According to the complaint, the company also failed to follow the current good manufacturing practice (cGMP) requirements for dietary supplements, as required by federal law.
Claims made by Syntec Inc. acknowledge that their products may be used to assist in the treatment of asthma, cardiovascular disease, cataracts, glaucoma and infections. Contradictory to what the company has emphasized, the FDA has not approved their products for the treatment of the previously mentioned diseases.
According to Dara Corrigan, the FDA’s associate commissioner for regulatory affairs, “marketing new drug products without FDA review or approval is dangerous because the products may cause consumers to delay or avoid legitimate treatments.” Fraudulent practices such as this exhibit a significant disregard for public safety and may result in catastrophic adverse events for those deceived by Syntec Inc.
According to an FDA News Release, Syntec Inc. allegedly mislabeled their products in a manner that was intended to deceive consumers and the agency. A number of their products, labeled as dietary supplements, falsely promised the same treatments intended by those of therapeutic drugs. The following products were marketed by Syntec Inc. with indications that were not approved by the FDA:
While allegations against Syntec Inc. are severe in nature, they are by no means unfamiliar territory. March 2009 witnessed the FDA send a warning letter to the drug manufacturer for making similar false claims. According to the March 13 letter, Syntec Inc. knowingly marketed their products as dietary supplements, even though the therapeutic implications classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act. The therapeutic claims on their website establish that the products are intended to be used as drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. However, by marketing them as dietary supplements, the company was able to avoid strict regulations embossed by the FDA.
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, 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.