On April 24 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 April 24 that lists the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.
On April 23 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 22 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On April 17 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 April 17 that lists the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration intends to exercise enforcement discretion on nutrition facts labeling for the sweetener allulose while it considers rulemaking on the subject, it said in a draft guidance document. FDA will not require that allulose be listed as a sugar or an added sugar on nutrition labels because the substance does not have the same effects on the human body as other sugars, though allulose must still be listed as a carbohydrate due to its chemical structure. However, unlike other carbohydrates, which FDA considers to have 4 calories per gram for nutrition labeling purposes, allulose may be considered to have 0.4 calories per gram, FDA said.
The Food and Drug Administration is extending the comment period on its proposed rule to create a “monograph” for over-the-counter sunscreen that would set conditions for selling sunscreen in the U.S. without prior approval from the agency (see 1902210019). The proposed rule would formally allow sale in the U.S. of sunscreens, without a new drug application, that contain certain ingredients recognized by FDA to be safe. FDA currently operates under a policy of enforcement discretion for unapproved sunscreens that contain ingredients that were set to be recognized as safe in an earlier rulemaking effort on sunscreens (see 1805220043). Comments are now due June 27. FDA also issued a correction to its Feb. 26 proposed rule.
SAN ANTONIO -- Increasing levels of manual review for filers of Food and Drug Administration regulated goods that fail evaluations should act as a deterrent for non-compliant filers and encourage them to correct issues quickly, said Alex Lopez, director-compliance at FDA’s Division of Southwest Imports, on a panel at the National Customs Brokers & Forwarders Association of America's annual conference on April 17.