Friday, May 12, 2023
Thursday, May 11, 2023
FDA is notifying consumers of certain products promoted for weight loss that have been found to contain hidden ingredients and might pose a significant health risk:
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
Wednesday, May 10, 2023
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter |
|---|---|---|---|---|---|---|
| Joyetech Shenzhen Electronics Co., Ltd. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Drivergent, Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated | ||||
| Premier Nutra Pharma Inc. | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated |
FDA is notifying consumers of certain products promoted for pain relief that have been found to contain hidden ingredients and might pose a significant health risk:
- Public Notification: Fast-Act Rheuma Capsule contains hidden drug ingredients
- Public Notification: New Fast-Act Rheumatism Capsule contains hidden drug ingredient
- Public Notification: UA-Block contains hidden drug ingredient
Immediate public notifications are issued when FDA testing identifies 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
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 R
FDA Announces Project to Provide Key Tool for Animal Biotechnology Developers
Today the U.S. Food and Drug Administration is announcing a joint project with the National Institute of Standards and Technology (NIST) that aims to provide an important new resource for researchers and companies creating innovative animal biotechnology products by using genome editing to alter the genome of animals. This project is part of the FDA’s efforts to further development of safe, beneficial biotechnology products.
The FDA is committed to facilitating advancements in development of innovative animal products by providing greater certainty in the regulatory process, encouraging development and research, and supporting an efficient and predictable pathway to market for Intentional Genomic Alterations (IGAs) in animals. Genome-editing technology, like CRISPR, has revolutionized the ability to make targeted changes to an animal’s genome, offering exciting promise for the creation of animal biotechnology products that address public and animal health concerns.
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Friday, May 5, 2023
| Tager Online, Inc. DBA Volt Candy; Volt Candy Wholesale Club | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | ||||
| Nose Slap LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | ||||
| Accra-Pac, Inc. dba Voyant Beauty | Division of Pharmaceutical Quality Operations III | CGMP/Finished Pharmaceuticals/Adulterated | ||||
| FuZion Vapor LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Medolife Rx D/B/A MedoLife Corp., AELIA, Inc. and Quanta Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | ||||
| Milky Way International Trading Corporation | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | ||||
| Str8Vape, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | ||||
| Pharmaplast S.A.E. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | ||||
| Juicer Connections, Inc. | Division of Human and Animal Food Operations West V | Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
On Monday, the FDA warned consumers to not purchase or use Nose Slap and Soul Slap products, which are unapproved drugs marketed to promote alertness and boost energy. These products are inhalants and primarily contain ammonia. Inhaling ammonia can quickly lead to eye, nose, and throat irritation; coughing; and airway constriction. The FDA has received reports of adverse events such as shortness of breath, seizures, migraines, vomiting, diarrhea, and fainting from consumers after using the Nose Slap or Soul Slap products. These products may have been purchased online through the Nose Slap website. On April 24, 2023, FDA issued a warning letter to Nose Slap LLC for marketing these unapproved drugs in violation of the Federal Food, Drug, and Cosmetic Act. These products have not been demonstrated to be safe or effective for their intended uses. Failure of the company to promptly correct violations may result in legal action without further notice, including, without limitation, product seizure and injunction.
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