Reports that the United States Food and Drug Administration has requested dietary supplement makers to voluntarily recall products that contain gamma butyrolactone (GBL). Physiological effects of GBL; Brand names available in the US; Advers...
(s)); • made in response to a customer complaint, request, or suggestion; • made in association with any recall or corrective action, see also 21 CFR 820.100 (FDA recommends that the applicant list the recall number or identify if considered a class III recall); 5 Contains Nonbinding...
The FDA notified the company on Friday that it had 24 hours to halt distribution and begin its own recall ofkratom-containing products, such as Raw Form Organics Maeng Da Kratom Emerald Green. The FDA said it ordered the recall on Monday after the company did not respond. This week's acti...
Keeping its focus on unintended consumption or unintended overconsumption, the FDA also chastised one company for failing to specifically list CBD as an ingredient on the label of its hemp-infused tea. This is particularly important to note for hemp companies, many of which have sought to avoid...
Reumofan Plus: Recall - Undeclared Drug IngredientJun 1, 2012 | Audience: Consumer, Health Professional, Emergency Medicine ISSUE: FDA is warning consumers that Reumofan Plus, marketed as a natural dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ...
2022 Biological License Application Supplement Noteworthy Approvals 2022 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals Other Applications Approved or Cleared by the Center for Biologics Evaluation and Research (CBER) Medical devices involved in the collection,...
NDA holder notifiesFDA that it does not intend to market upon approval, the NDA drug product will,in the month following such approval, appear in the Discontinued Section. The monthly cumulative supplement of the Orange Book is generally updated at the end of the second full week of each ...
The bill would require dietary supplement facilities to provide FDA with information on supplements and their ingredients on an ongoing basis, would substantially alter the requirements applicable to new dietary ingredients ("NDI’s"), would give FDA mandatory recall authority, and would expand adverse...
When needed, the FDA can directly recall faulty medical devices. It can’t directly recall drugs, but it can take legal action to force a recall if needed. The FDA also can request or order food recalls so you know what to do if you have a food that could be harmful already in ...
Dietary supplements.The FDA has some limited power to regulate supplements, such as vitamins, minerals, and herbal products, but doesn’t review or approve them before they go on the market. Supplement makers can get into trouble if they mislabel products or include harmful ingredients. ...