email us: mark<at>markzamora.com or joey<at>bunchandjames.com
Our lawyers investigate claims of wrongdoing by companies whose products allegedly injure hard working consumers.
While we do our level best to right a wrong and seek justice, it is incumbent on all citizens to push for real reform at the FDA. The FDA lacks sufficient funding and personnel to oversee the safety of products people put in and on their bodies.
The FDA has its hands full. Here are recent reports, below that show that companies that don’t want to follow FDA regulations simply don’t. They then put their products on the market, putting innocent people at risk.
ViaExtreme:
Public Notification: “ViaXtreme” Contains Undeclared Drug Ingredient
The Food and Drug Administration (FDA) is advising consumers not to purchase or use “ViaXtreme,” a product for sexual enhancement sold on various websites. Claims made for the product falsely state that it contains “all-natural ingredients” and that it has “no side-effects.”
FDA laboratory analysis confirmed that “ViaXtreme” contains the undeclared ingredient sulfoaildenafil. Sulfoaildenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for Erectile Dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.
Consumers should stop using this product immediately and throw it away. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.
Herbal Nitro Inc.
On May 3 through May 10, 2011, the U.S. Food and Drug Administration (FDA) inspected your dietary supplement firm located at 35133 Ravencrest Ct., Yucaipa, CA. During the inspection, you informed our investigators that your firm is an own-label dietary supplement distributor that enters into agreements with contract manufacturers to manufacture your dietary supplement products, and supplies such contract manufacturers with raw materials, including components used in the manufacture of your dietary supplement products. You also stated that these contract manufacturers are required to meet your firm’s dietary supplement formulations. As an own-label dietary supplement distributor that contracts with other manufacturers to manufacture dietary supplements that your firm releases for distribution under your firm’s name, FDA considers you to be a manufacturer of dietary supplements. As such, you have ultimate responsibility for the dietary supplements that you introduce or deliver for introduction into interstate commerce.
During the inspection, our investigators found that you have significant violations of the Current Good Manufacturing Practice (CGMP) regulation for Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
These violations cause your dietary supplement products to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements in 21 CFR Part 111.
Your significant violations are as follows:
1. Your firm failed to establish specifications for identity, purity, strength, and composition for each component that you use in the manufacture of your dietary supplement products, as required by 21 CFR 111.70(b). Specifically, during the inspection, you told our investigators that your firm has not established any specifications for the components that your firm uses in the manufacture of your dietary supplement products
Remember, this is in 2011
When a company is caught – what happens? In NJ a company basically said it did not care what agreement it reached regarding a supplement. After agreeing to stop making dangerous products, the company opened a new office and did just that.
The entire process took almost 3 years to close out.
A Trenton, N.J., jury Wednesday found Paterson, N.J.-based dietary supplement companies Quality Formulation Laboratories Inc. and American Sports Nutrition Inc., as well as their owner, Mohamed S. Desoky, and managers Ahmad Desoky Esq. and Omar Desoky, guilty of multiple counts of criminal contempt of court for violating a consent decree, the Justice Department announced today. The decree was entered by the U.S. District Court for the District of New Jersey on March 16, 2010. The decree, which resolved a civil action filed by the Justice Department as the result of an investigation by the Food and Drug Administration (FDA), mandated Mohamed S. Desoky and the two companies shut down all manufacturing and distribution activities of food products.
The defendants’ businesses manufactured and distributed food products and supplements, including many varieties of protein powder mixes, as well as other powder mixes and dietary supplements. The products were distributed under the American Sports Nutrition brand and many other private labels to locations throughout the United States.
The complaint in the civil case that led to court order alleged that the defendants, which included Mohamed S. Desoky, Quality Formulation Laboratories Inc., and American Sports Nutrition Inc., adulterated food by manufacturing it without following FDA’s regulations regarding current good manufacturing practice (CGMP) requirements, and causing the adulteration of food by preparing it under insanitary conditions whereby it may have become contaminated with filth (as a result of rodent activity) or may have been rendered injurious to health (as a result of cross-contamination with a major food allergen).
The complaint alleged that the defendants caused misbranding of food because the food contained a major food allergen (milk) not declared on the product labels. The civil complaint went on to allege that defendants’ failure to have adequate sanitizing and cleaning operations and follow their own procedures for manufacturing products on dedicated equipment, may have led to food being contaminated with this major food allergen by virtue of “cross-contamination” or “cross-contact” in the manufacturing process. The civil complaint alleged that during an FDA inspection of the defendant’s facility in December 2008 and January 2009, FDA investigators observed a dead rodent – cut in half- on a blender motor platform; a dead rodent, surrounded by rodent excreta pellets in an area used to store near-finished product; and, on two occasions, a live rodent running through the blending room. Additionally, the complaint alleged that investigators observed bags of raw ingredients that were gnawed through by rodents and covered in rodent urine and excreta pellets.
The consent decree that settled the civil action required that defendants shut down their manufacturing operation and not reopen there or elsewhere without first correcting these violations and getting FDA’s approval to reopen. The criminal contempt charges alleged that Ahmad Desoky and O. Desoky, with knowledge of the court’s order, assisted their father, Mohamed S. Desoky, in violating the order, and thus were criminally liable for the violations even though they were not named as defendants in the original civil case.
The petition for criminal contempt charged all five defendants with violating the decree almost immediately upon its entry by setting up operations at a separate location in Congers, N.Y., to which they transported their employees and equipment. In addition, the petition alleged that the defendants violated the decree by failing to notify FDA of this relocation of their operations. All five defendants were found guilty of these charges.
FDA Recalls and The Law 