November 6, 2011 — Last week, the FDA sent U.S. Marshals to seize all dietary supplements manufactured by Syntec, Inc. (Syntec Nutraceuticals), because the company is violating safety regulations, and misleading customers about the drugs’ safety and effectiveness. Syntec has been issued several warnings for failing to obey current Good Manufacturing Practices (cGMP). The company has ignored FDA requests to change product labeling and comply with cGMP, placing consumers at risk.
Syntec dietary supplements contain drugs that are not FDA-approved.
Furthermore, the product labels mislead consumers by stating that they are effective at treating several ailments — including asthma, cardiovascular disease, cataracts, glaucoma, and infections. In reality, Syntec products do not treat, cure, or prevent any disease. In 2009, the FDA warned Syntec that it must stop labeling its products with the false claim that it can treat diseases. Syntec ignored the FDA letter, and has continued manufacturing and selling the products.
Syntec Inc. manufactures the following products: SynBio, SynOPC, BoneCare, SynBio-X, SynOPC-X, VisionCare, CardioCare, SynGevity, SynVita, SynCell, SynPhyto-K, DigestiveCare, JointCare, and SynOmega.
As of today, Syntec’s website makes several false claims about their compliance with the FDA and cGMP. “As a food manufacturer, Syntec is subject to and consistently passes audits by FDA and USDA inspectors.” Another statement on the website reads: “Syntec manufactures all supplements according to current Good Manufacturing Practices established by the FDA.”
The evidence proves otherwise. Inspections of the manufacturing facility in October 2010, November 2010, June 2011, and September 2011 found serious violations of Good Manufacturing Practices. The FDA sent the company warning letters each time, but Syntec refused to comply with the regulations. The cGMP are federal regulations for dietary supplements, intended to maintain a standard of safety so that the drugs can be sold throughout the U.S.
Dara A. Corrigan, the FDA’s associate commissioner for regulator affairs, had this to say about the seizure of Syntec products: “Marketing new drug products without FDA review or approval is dangerous because the products may cause consumers to delay or avoid legitimate treatments. The FDA is committed to protecting consumers from unapproved new drugs.”
One major risk is that people who are sick will be misled by Syntec labeling, and decide to treat their sickness with Syntec products instead of visiting a doctor, a hospital, or receiving FDA-approved drugs proven to treat diseases. Because Syntec products do not actually work, there is a possibility that consumers will get sicker. Another risk-factor is that the Syntec products contain unapproved drugs, which may have serious, life-threatening side effects. Syntec products come in individual-sized packages (usually a powdered drink mix), with no warning labels.
If you or someone you know has been injured by Syntec products, you may be entitled to compensation. Contact a lawyer at the Clark Firm LLP for a free consultation.
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The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact us for a free SynBio, SynOPC, BoneCare, SynBio-X, SynOPC-X, VisionCare, CardioCare, SynGevity, SynVita, SynCell, SynPhyto-K, DigestiveCare, JointCare, or SynOmega lawsuit review or you may also call us directly by dialing (866) 879-3040.