September 18, 2021

Supplement Company Owner Pleads Guilty to Selling Steroid-Like Drugs

A New Jersey supplement company owner pleads guilty to introducing an unapproved new drug into interstate commerce "with the intent to defraud and mislead the U.S. Food and Drug Administration (FDA) and consumers," according to a news release from the U.S. Department of Justice.  The owner is Nicholas Andrew Puccio. The government alleges that from 2016 to 2020, Puccio marketed drugs as dietary supplements to the bodybuilding and fitness community. The supplements allegedly included a product labeled as containing ostarine, a type of synthetic steroid known as a Selective Androgen Receptor Modulator (SARM). Dietary supplements cannot contain unapproved drugs or they are considered unapproved new drugs by the FDA. The FDA has long warned against the use of SARMs, stating that they … [Read more...]

Imperia Elita Vitaccino Coffee Recalled For Undeclared Drugs

Dash Exclusive is voluntarily recalling all lots of Imperia Elita Vitaccino Coffee because it contains sibutramine and fluoxetine, two drugs that are not declared on the label. This product is a weight loss and anxiety dietary supplement. FDA analysis found the presence of these compounds in the product. The company has not received any reports of adverse reactions related to the use of this recalled product. Sibutramine was an FDA-approved drug that was used as an appetite suppressant. It was withdrawn from the marketplace because of safety issues, including stroke, heart failure, and serious health risks, especially for people who have underlying heart disease. Sibutramine can significantly increase blood pressure and pulse rate. Fluxoetine is an FDA-aprpved drug that is used … [Read more...]

FDA Warns Two Companies Selling OTC CBD Products For Pain Relief

The FDA has issued warning letters to two companies selling OTC CBD products for pain relief. The items are labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The letters address the illegal marketing of unapproved drugs labeled as containing CBD. The FDA has not approved any over-the-counter (OTC) drugs containing CBD, and these products do not meet the requirements to be legally marketed without an approved new drug application. CBD has known pharmacological effects on people, with demonstrated risks, so it can't be legally marketed as an inactive ingredient in OTC drug products that are not approved by the FDA. The letters also cite substandard manufacturing practices, including the failure to comply with … [Read more...]

Sundial Herbal Products Recalled For Unapproved Drugs and Misbranding

Sundial Herbal Products are being recalled for unapproved drugs to be in compliance with FDA Drug Regulations. These recalled products are misbranded because they have labeling claims that could result in delay of appropriate treatment by a healthcare provider. Because these dietary supplements are unapproved, their safety and efficacy have not been established. No illnesses or adverse reactions have been reported by the company to date. The recall headline states that "recall is required by the order." All products used as Sundial Herbs can be identified with the "Sundial" label. They were sold in brown glass bottles, boxes, ziplock bags, and  paper bags wit clear viewing windows. They were distributed nationwide or statewide through the Sundial Herb website or any other website. … [Read more...]

Herbal Doctor Remedies Recalls Products Marketed Without FDA Approval

Herbal Doctor Remedies is voluntarily recalling all drug products within expiration dates to the consumer level. These products were marketed without FDA approval and were manufactured outside controls required by current Good Manufacturing Practices. This could result in risk to consumers, since they are marketed with uses that are not amenable to self-diagnosis. And, lack of controls in the manufacturing of these products do not provide assurance of quality. No reports of adverse reactions have been received to date by the company. These products are intended to be used as Chinese Herbal Medicines, marketed for treatment of diseases in people which the FDA has found makes them unapproved new drugs. These recalled Herbal Doctor products are packaged in white plastic … [Read more...]

Rhino 5K Capsules Recalled for Unapproved Drugs

Happy Together, a company in Boynton Beach, Florida, is recalling all lots of Rhino 5K capsules because they are tainted with sildenafil and Tadalafil. Sildenafil and Tadalafil are FDA approved drugs that are available only through prescription. Those drugs render the product as a whole an unapproved drug for which efficacy and safety has not been established, therefore subject to recall. No adverse reactions have been reported to date in connection with this recall. Men with diabetes, high blood pressure, heart disease, or high cholesterol may be taking prescription meds that could interact with these products and cause dangerously low blood pressure that could be life-threatening. The company can't identify customers who bought this product, so they are making a public announcement … [Read more...]

Permanent Injunction Issued Against Dietary Supplements Containing Undisclosed Drugs

The U.S. District Court for the District of New Jersey has entered an order of permanent injunction against S. Hackett Marketing LLC doing business as Just Enhance. This injunction requires the defendants to cease the distribution of their products until they take remedial measures and comply with the Federal Food, Drug, and Cosmetic Act. The notice states that the defendants violated the Act by selling unapproved drugs and misbranded drugs to consumer on more than 100 different websites. The complaint states that the label on these products claimed, without FDA approval or any clinical studies demonstrating safety and effectiveness, that they could treat or provident serious conditions. Some of those conditions included impotence and prostatitis. Testing at the FDA laboratory … [Read more...]

Sienna Laxative and Flawless Beauty Recalled for Mislabeling and Unapproved New Drug

Two products regulated by the FDA have been recalled; one, Sienna Laxative, for mislabeling, and the other, Flawless Beauty products, because it contains an unapproved new drug. No illnesses or adverse reactions have been reported. The first recall is for Flawless Beauty products. In accordance with a Consent Decree of Permanent Injunction, the company is voluntarily recalling all lots of 19 different products that were sold individually or as part of multi-unit kits because they are unapproved new drugs. These products were sold over the internet to U.S. and foreign customers. All glutathione products were sold in multi-vial whitening kits. The FDA believes that these drugs present serious public health risks. You can see the long list of recalled products at the FDA web site. … [Read more...]

Marmex Corporation Recalls Blue Pearl Dietary Supplement for Undeclared Sildenafil

Marmex Group is voluntarily recalling all lots of Blue Pearl All Natural Male Enhancement Supplement because the product contains sildenafil, which makes it an unapproved drug. Products with undeclared sildenafil may pose a threat to consumers because the active ingredient can interact with nitrates in some prescription drugs and lower blood pressure to dangerous levels. No adverse effects have been reported to date in connection with this issue. Consumers with high blood pressure, diabetes, high cholesterol, or heart diseases often take nitrates and may be the most likely to be affected by this undeclared drug. The safety and efficacy of this product has not been established. The recalled products is Blue Pearl All Natural Male Enhancement Supplement capsules in 500 mg packages. … [Read more...]

FDA Warns Companies That Make Coco Loko and Legal Lean as Unapproved New Drugs

The FDA is warning makers and manufacturers of two products, Legal Lean Syrup, a drink, and Coco Loko, a "snortable" chocolate powder, for selling unapproved new drugs and misbranded drugs. These products are promoted as alternatives to street drugs. The government has sent a warning letter to one company about this problem. Claims made in the promotional materials for the products demonstrate they are intended to be used as alternatives to street drugs. These products, as labeled and marketed, "may pose safety concerns," according to the press release. The FDA is concerned that these products encourage drug abuse in individuals, including minors. These street drug alternatives are used for recreational purposes to affect psychological states. FDA Commissioner Scott Gottlieb said … [Read more...]

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