2. COLA’s: Who Needs Them Gary Horton Senior Project Manager, Regulatory Affairs & Compliance E. & J. Gallo Winery

3. Why do we need COLA’s TTB review assures compliance with laws and regulations. ◦ Everyone subject to a uniform set of requirements. ◦ Public COLA Registry.  Can see how TTB applies the rules. ◦ TTB enforcement against failure to obtain COLA. ◦ Not the case with FDA.

4. Why do we need COLA’s – cont’d States depend on TTB’s review. Would states implement their own review and approval process? ◦ Without TTB review and approval, more non- compliance and illegal labels. ◦ More scrutiny by states with existing brand registration requirements. ◦ Non-brand registration states, such as California, may implement a label review and approval process to fill the gap.

5. Here’s an example of a label without federal review and follow- up

6. And another

7. And…it’s the law 27 U.S.C. § 205. Unfair competition and unlawful practices ◦ In order to prevent the sale or shipment or other introduction of distilled spirits, wine, or malt beverages in interstate or foreign commerce, if bottled, packaged, or labeled in violation of the requirements of this subsection, (1) no bottler of distilled spirits, no producer, blender, or wholesaler of wine, or proprietor of a bonded wine storeroom, and no brewer or wholesaler of malt beverages shall bottle…unless, upon application to the Secretary of the Treasury, he has obtained and has in his possession a certificate of label approval covering the distilled spirits, wine, or malt beverages, issued by the Secretary in such manner and form as he shall by regulations prescribe. ◦ TTB cannot stop issuing COLAs unless the law is changed.

8. Thank you.