International Trade Today is a service of Warren Communications News.
Subscriber Login
FDA
to
Refine Category Search
Clear Terms

Search Primer

Multi-word term: Place inside quotes to ensure an exact match together (e.g. "China import").

Term list: Separate terms with spaces, not commas or semicolons to find either word (e.g. AD/CVD antidumping).

Acronyms: Use all capital letters (e.g., ACE).

Required term: If a term must be included in any resulting articles, prefix it with a plus sign (e.g., CBP +releases).

Excluded term: If a term should be excluded from any articles being found, prefix it with a minus sign (e.g., -ruling).

Singular form: Use the singular form when doing multi-word terms (e.g. "russian export control" instead of "russian export controls").

Shortest word form: When you have different word forms in a quoted term, include the shortest version if it is the last part of the expression (e.g., "entity list" instead of "entity listing" or "entity listed").

FDA Releases Guidance on new Vending Machine Calorie Labeling Regulations
August 16, 2016 |FDA

The Food and Drug Administration released a draft guidance (here) and a small entity compliance guide (here) to help businesses comply with new vending machine calorie labeling rules, it said (here). Under FDA’s 2014 final rule, vending machine operators do not have to declare calorie information for a food if a prospective purchaser can view certain calorie information on the front of the package, in the nutrition facts label on the food, or in a reproduction of the nutrition facts label on the food subject to certain requirements. Comments on the draft guidance are due Sept. 30, FDA said (here). FDA also posted a list of compliance dates for the final rule (here).

FDA Adopts new Criteria for Declaring Food Ingredients 'Generally Recognized as Safe'
August 16, 2016 |FDA

The Food and Drug Administration clarified criteria for declaring food ingredients are “generally recognized as safe” (GRAS) and are not “food additives” requiring agency approval, in a final rule (here). Under the amended regulations, FDA is replacing the former affirmation petition process, whereby companies could petition FDA for a rulemaking declaring a substance is GRAS, with a notification procedure the agency has been piloting since 1998. FDA will respond to the notifier in writing, raising any issues the agency has with the company’s conclusion that a substance is GRAS, and will make “readily accessible to the public a basic description of the notified substance, the conditions of its intended use, and the statutory basis for its GRAS status,” it said. The final rule takes effect Oct. 17.

FDA Seeks Comments on Application, Record-Keeping Burden of VQIP Trusted Trader Program
August 16, 2016 |FDA

The Food and Drug Administration is seeking comments on the burden importers will face if they participate in the upcoming Voluntary Qualified Importer Program, as well as on other aspects of the program’s information submission and record-keeping requirements (here). The agency said it expects 200 applicants in the program’s first year, with each application requiring 80 to 100 hours to complete, and reapplications for subsequent years taking 20 hours. Each importer will also have to compile a quality assurance plan, which should take 160 hours to put together in year one, and 16 hours to update each subsequent year of participation. FDA has said it hopes to begin accepting applications for VQIP, a trusted trader program for food importers that will give participants the benefit of fewer examinations and expedited laboratory analysis, in January 2018, with importers seeing the first benefits the following October (see 1511230022). Comments are due to the Office of Management and Budget by Sept. 15.

AAEI Asks for More Time for Comments on FDA ACE Requirements
August 16, 2016 |FDA

The American Association of Exporters and Importers is seeking an extension of the deadline for comments on the Food and Drug Administration’s ACE filing procedures, it said in a letter to the agency dated Aug. 9 (here). Commending FDA for issuing a proposed rule June 30 that outlines the agency’s newly mandatory ACE requirements (see 1606300020), AAEI nonetheless said the trade community needs more time to respond. Importers are still managing the impact of FDA’s ACE deadline of June 15 and CBP’s July 23 deadline for quota, and haven’t had the time to develop complete responses to FDA’s notice, it said. Industry also needs more time to discuss new data elements required by FDA with service providers like customs brokers and express carriers, the letter said. AAEI requested another 60 days to respond to FDA’s proposed rule. Comments are currently due Aug. 30.