January 12, 2017
John J. Manfreda
Alcohol and Tobacco Tax and Trade Bureau
Department of the Treasury
1310 G Street, NW., Box 12
Washington, DC 20005
Dear Mr. Manfreda:
On September 9, 1991, FDA issued a letter to the Deputy Director of the Bureau of Alcohol, Tobacco, and Firearms (BATF) (now the Alcohol and Tobacco Tax and Trade Bureau). The letter stated, among other things, that FDA would advise BATF, on a case-by-case basis, whether a particular table wine product containing more than 300 parts per billion (ppb) of lead meets the standards for adulteration under the Federal Food, Drug, and Cosmetic Act (FD&C Act). In 2007, to make the letter accessible, FDA issued a final guidance document based on the 1991 letter on FDA’s Web site entitled “Guidance for Industry and FDA: 1991 Letter to Bureau of Alcohol, Tobacco and Firearms Regarding Lead in Wine.”
Since 1991, FDA has gained a greater understanding of the health risks associated with lead exposure. In 1996, FDA published a final rule banning the use of tin-coated lead foil capsules, a recognized source of lead contamination, for wine bottles (61 FR 4816; also see 21 CFR 189.301). More recent data indicate that lead levels in wine well below 300 ppb are achievable through good manufacturing practices. Therefore, we will withdraw the 2007 guidance. The withdrawal of this outdated guidance is consistent with FDA’s requirements for good guidance practices, under which FDA guidance documents that are obsolete and no longer useful should be withdrawn.
Consistent with our Memorandum of Understanding (52 FR 45502) dated November 20, 1987, FDA will continue to advise TTB, on a case-by-case basis, whether a particular product containing lead meets the standards for adulteration under the FD&C Act.
This letter replaces FDA’s 1991 letter.
Office of Food Safety
Center for Food Safety and Applied Nutrition