Monthly Archives: November 2016
Obtaining a COLA (Certificate of Label Approval) from the TTB can be a time-consuming process that’s difficult to sync with the rest of your operations. But here’s a little-known fact: if you are importing alcoholic beverages for use at a tradeshow, or to give out samples for soliciting orders, you may be eligible for a COLA waiver.
COLA waivers can be requested by submitting a formal letter to the TTB. The letter must guarantee that the products in question will meet these compliance requirements before reaching a U.S. port:
• The products will be imported by the holder of a Federal Importer’s Basic Permit (you also need to include the permit number)
• All applicable taxes and duties will be paid
• The imported products will have the following labels:
o Government Warning Statement (Code of Federal Regulations, Title 27, Subpart 16)
o Purpose label (e.g. “For Trade Show Purposes Only – Not for Sale”)
o A sulfites disclaimer for eligible wines (e.g. “CONTAINS SULFITES”)
The letter also has to provide information regarding the details of the products you need waivers for, including:
• The purpose for importing and for requesting a waiver (for tradeshows or other events, include dates and locations)
• The class, type, and quantity of each alcoholic beverage product
• The country of origin for each product
• The brand name of each product
The TTB accepts these waiver requests by both email and fax (202-453-2970). To make the process even faster and easier, I recommend using this official template provided by the TTB (this opens a MS Word file you can save and modify).
Even though the primary regulatory authority for the alcoholic beverages is the TTB, the FDA does have some power in the industry. Since many alcohol manufacturers aren’t sure when or where they may be subject to FDA regulations, I thought I’d shed some light on the agency.
Currently, the TTB and the FDA operate together under a non-binding Memorandum of Understanding, which basically outlines when, why, and how the TTB refers issues to the FDA. These issues are largely related to health and safety. For example, if you submit a formula to the TTB for a distilled spirit containing an unusual ingredient, the TTB will deny your application unless you can provide documentation certifying that the ingredient is Generally Regarded as Safe (GRAS) by the FDA for use in alcoholic beverages. You may recall the big industry upset circa 2010 when the FDA declared caffeine as an unsafe food additive for alcoholic beverages.
Beyond issuing certificates and declarations, there are circumstances where the FDA has more active authority. As part of the agency’s mission to promote food items that are properly labeled and safe for consumption, the FDA can take action in cases of adulterated or contaminated food products – including domestic and imported alcoholic beverages. Specifically, if alcoholic beverages have been reported as adulterated, the FDA has the power to seize those products, refuse their importation, and actively discourage their distribution through consumer markets. Generally, this happens when a manufacturer has been slow or ineffective at implementing a product recall.
In addition to formulation approvals, food safety compliance, and product recall procedures, alcohol manufacturers may also need to interact with the FDA on issues including:
• Registration of food facilities
• Labeling of wines and ciders containing less than 7% alcohol by volume
• Labeling of beers that do not contain barley or hops
• Facility inspections
If you have any questions about FDA jurisdiction in your business or other regulatory compliance issues, I’d be happy to help.