FDA is notifying consumers of certain products marketed for energy that have been found to contain hidden ingredients and might pose a significant health risk.

• BIG GUYS Male Energy Supplement contains hidden drug ingredient
• Mens Maximum Energy Supplement contains hidden drug ingredient
• Round 2 contains hidden drug ingredient
• Genergy contains hidden drug ingredient
• WeFun contains hidden drug ingredient
• X MAX Triple Shot Energy Honey contains hidden drug ingredient

Immediate public notifications are issued when FDA testing finds that a product contains active drug ingredients not listed on the product labels, possibly including ingredients found in prescription drugs. These products might cause potentially serious side effects and might interact with medications or dietary supplements a consumer is taking. Consumers should use caution when considering purchasing these types of products. 

FDA's Health Fraud Product Database includes only a small fraction of the potentially dangerous products marketed to consumers online and in stores. 

Consumers and health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

MedWatch Safety Reporti

 FDA is notifying consumers of certain products marketed for sexual enhancement that have been found to contain hidden ingredients and might pose a significant health risk.

• BIG GUYS Male Energy Supplement contains hidden drug ingredient
• Mens Maximum Energy Supplement contains hidden drug ingredient
• Round 2 contains hidden drug ingredient
• Genergy contains hidden drug ingredient
• WeFun contains hidden drug ingredient
• X MAX Triple Shot Energy Honey contains hidden drug ingredient
• Vegetal Vigra 200mg contains hidden drug ingredient

Immediate public notifications are issued when FDA testing finds that a product contains active drug ingredients not listed on the product labels, possibly including ingredients found in prescription drugs. These products might cause potentially serious side effects and might interact with medications or dietary supplements a consumer is taking. Consumers should use caution when considering purchasing these types of products. 

FDA's Health Fraud Product Database includes only a small fraction of the potentially dangerous products marketed to consumers online and in stores. Even if a product is not included in this list, consumers should exercise caution before using these types of products.

Learn More

 

FDA’s Dietary Supplements Program Remains a Critical Priority

As we announced at the start of the year, the FDA is embarking on an ambitious plan to transform our current organizational structure in the various foods programs into a unified Human Foods Program (HFP). These changes will improve how we protect the nation’s food supply, improve access to safe and nutritious foods and enhance our understanding of chemical safety and nutrition. I’d like to catch up with you to share more details about our dietary supplements program under the proposed reorganization. 

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Department of Justice News: Justice Department Files Complaint to Enjoin Arizona Company and Its Owner from Manufacturing and Distributing Unapproved Animal Drugs

The Justice Department announced today that the United States filed a complaint to enjoin a Gilbert, Arizona, company from manufacturing and distributing products the government alleges to be adulterated and unapproved new animal drugs, the Justice Department announced today.

In a civil complaint for permanent injunction filed Aug. 29, in the U.S. District Court for the District of Arizona, the United States alleges that AniCell Biotech LLC and its owner, Brandon T. Ames, violated the Federal Food, Drug and Cosmetic Act (FDCA). According to the complaint, the defendants manufacture products under the brand names EquusCell and CanisCell consisting of injectable and intravenous liquids, eye drops and grafts derived from the amniotic tissue of horses. The complaint alleges that the defendants claim on their website and in promotional pamphlets that their products are intended for use in horses, dogs and cats to treat various diseases, such as osteoarthritis and renal failure, and to promote tissue regeneration and healing.

 

CVM Federal Register Notices

The following Federal Register Notices are now available:

Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals
August 31, 2023; 88 FR 60213

Agency Information Collection Activities; Proposed Collection; Comment Request; Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine
August 31, 2023; 88 FR 60212

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Rapid Response Surveys
August 31, 2023; 88 FR 60211

 

An Update on FDA’s Overdose Prevention Framework - Addressing Critical Areas of Need

Preventing and reducing substance use disorders and overdose deaths remains a priority of mine and an area of major focus at the U.S. Food and Drug Administration. I would like to take this time to reflect on International Overdose Awareness Day, Aug. 31, 2023, which reminds us of what’s at stake and acknowledges people in our communities who are affected by overdose but might go unseen in the crisis.

The agency continues to take actions in response to the four priorities outlined in the FDA’s Overdose Prevention Framework one year ago, including primary prevention, encouraging harm reduction, advancing evidence-based treatments for substance use disorders, and protecting the public from unapproved, diverted, or counterfeit drugs.

While we have made progress in many areas, the crisis has grown into an even more dangerous public health challenge. Last year, we had more than 107,000 overdose deaths, which means each day nearly 300 people died from a drug overdose. These deaths are primarily driven by illicit fentanyl and its analogs. Additionally, other controlled substances, such as stimulants and benzodiazepines, are being used in combination with opioids. And new challenges continue to arise. Here is an update on some activities we are taking across the agency in each of the Overdose Prevention Framework priorities.

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Recent Animal Drug Approvals and Safety-Related Labeling Changes

The FDA’s Center for Veterinary Medicine has updated its Recent Animal Drug Approvals page to reflect the August approvals of New Animal Drug Application 141-568 and Abbreviated New Animal Drug Applications 200-755, 200-756, and 200-757.

Recent Animal Drug Approvals

 

FDA Roundup: September 1, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Thursday, the FDA cleared for marketing the updated 23andMe Personal Genome Service (PGS) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). It is a direct-to-consumer (DTC) test that reports selected BRCA1/BRCA2 genetic variants from human saliva collected from individuals 18 years or older. The test was updated to add 41 BRCA1/BRCA2 variants to the previously authorized test.  The test analyzes DNA from a self-collected saliva sample and generates personalized reports that describe if the genetic variants detected in that sample are associated with an increased risk of developing breast and ovarian cancer and may be associated with an increased risk for prostate cancer, pancreatic cancer, and potentially other cancers. The variants included in this report do not represent the majority of the BRCA1/BRCA2 variants in people of most ethnicities. This means a negative result does not rule out the presence of other variants that increase cancer risk. These reports provide genetic information to inform discussions with a healthcare professional. Consumers and health care providers should not use the test results to substitute for healthcare visits for recommended cancer screenings or appropriate follow-up, and results from this test should not be used to determine any treatments.  This is the latest example of the FDA’s ongoing commitment to advance access to safe and effective DTC genetic testing intended to aid patients in having informed conversations with their healthcare providers. On Wednesday, the FDA issued a Safety Alert to advise restaurants and retailers not to serve or sell and consumers not to eat certain cultured mussels from East River Shellfish, Inc. due to a possible salmonella and E. coli contamination.

 2023 PDA/ FDA Joint Regulatory Conference | September 18 - 20, 2023

 FDA is notifying consumers of a product marketed for pain relief that has been found to contain hidden ingredients and might pose a significant health risk.

• Public Notification: Tapee Tea contains hidden drug ingredients

Immediate public notifications are issued when FDA testing finds that a product contains active drug ingredients not listed on the product labels, possibly including ingredients found in prescription drugs. These products might cause potentially serious side effects and might interact with medications or dietary supplements a consumer is taking. Consumers should use caution when considering purchasing these types of products. 

FDA's Health Fraud Product Database includes only a small fraction of the potentially dangerous products marketed to consumers online and in stores. Even if a product is not included in this list, consumers should exercise caution before using these types of products.

Learn More