On March 20-21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for March 21 that lists the status of recalls and field corrections for food, drugs, biologics and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration is extending the period for comments on its proposed new risk-based enforcement policy for unapproved homeopathic drugs. Under the policy, as described in a draft guidance issued Dec. 18 (see 1712190016), FDA would prioritize enforcement on unapproved drugs labeled as homeopathic based on their risk to human health, though “any product labeled as homeopathic that is being marketed illegally is subject to FDA enforcement action at any time,” the agency said. The draft guidance includes information on specific products and situations FDA will target in its enforcement activities. Comments are now due May 21.
The Food and Drug Administration issued a draft guidance document on the definition of “small business” under Food Safety Modernization Act regulations on preventive controls for human food and animal food. Under those regulations, small businesses are defined as any businesses, including subsidiaries and affiliates, that employ fewer than 500 full-time equivalent employees at all facilities. Small businesses have later compliance dates for the preventive controls regulations, and in some cases may be exempt if they meet the definition of “farm mixed-type facilities.” The draft guidance details how to determine a company’s number of full-time equivalent employees, including at affiliates and other facilities, and how small businesses are affected by the preventive controls regulations.
On March 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for March 14 that lists the status of recalls and field corrections for food, drugs, biologics and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration will delay until further notice certain provisions of its new regulations on when products made or derived from tobacco are subject to regulation as a drug, device or combination product, it said in a final rule. Under regulations issued Jan. 9, 2017, a product made or derived from tobacco is regulated as a drug, device or combination product: “(1) If the product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease; or (2) if the product is intended to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000" (see 1701060011). FDA's indefinite delay applies to provisions describing the types of evidence that may be considered in determining a medical product’s intended uses, it said. The overall effective date of all other provisions of the regulations continues to be March 19, 2018 (see 1703170030).
On March 13 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 9 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 8 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: