The Food and Drug Administration on Feb. 19 announced (here) a new guide (here) to help small businesses comply with regulations that recently took effect on omega-3 fatty acid content claims in food labeling. A FDA final rule issued in 2014 prohibits statements on labels that a food is “high in,” “rich in” or an “excellent source of” the omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), and restricts similar claims for alpha-linolenic acid (ALA) (see 14042829). The final rule took effect Jan. 1, 2016.
The Food and Drug Administration recently posted a list of valid unit of measure codes for filings in the Automated Commercial Environment (here) to its ACE/ITDS webpage (here). Use of a code not included on the list will result in an ACE entry rejection, said FDA. Each level of packaging should be declared, and the same code cannot be declared more than once, it said. The list also includes examples for each commodity type.
On Feb. 19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Feb. 18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Feb. 17 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Feb. 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Feb. 12 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 announced a public workshop April 5-6 at FDA headquarters in Silver Spring, Md. to discuss upcoming pilots required under the Drug Supply Chain Security Act. According to the agency’s notice (here), FDA is interested in getting input from drug supply chain members on “issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying the system attributes that are necessary to implement the requirements established” by the 2013 law. Requests to register are due by March 11. Written comments related to the workshop are due April 21.
On Feb. 11 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 Feb. 10 that lists the status of recalls and field corrections for food, drugs, biologics, and devices (here). The report covers both domestic and foreign firms.