The purpose of this letter is to provide guidance to industry and FDA staff. The letter sets forth FDA's recommendations concerning the daily intake of lead in table wines that would support a regulatory action by the U.S. Department of the Treasury's Alcohol and Tobacco Tax and Trade Bureau (TTB) (formerly the Bureau of Alcohol, Tobacco, and Firearms) and FDA's willingness to advise the TTB on a case-by-case basis. In addition, the letter suggests how TTB should conduct actions against violative table wines that may involve recalls.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

This letter was initially issued to the Deputy Director of the BATF in 1991, and we are putting it on the guidance page of the CFSAN Web site for ease of accessibility. As of January 24, 2003, a new organization within the U.S. Department of the Treasury, the TTB, became responsible for the BATF regulatory and enforcement functions referred to in this letter.

The 1991 letter references three future FDA actions: (1) preparing a public announcement that underscores the warning that pregnant and lactating women should avoid consumption of alcoholic beverages (Note: HHS NEWS release issued on September 9, 1991); (2) initiating rulemaking to establish a regulation that would limit lead in table wine (Note: This action has not been taken); and (3) publishing a Federal Register document that will propose to ban the use of lead capsules (Note: FDA published the proposed rule on November 25, 1992 (57 FR 55485) and the final rule on February 8, 1996 (61 FR 4816)).

September 9, 1991

Daniel Black
Deputy Director
Bureau of Alcohol, Tobacco and Firearms
Department of the Treasury
Washington, D.C. 20226

Dear Mr. Black:

By letter of August 2, 1991, Mr. Terry L. Cates requested, consistent with our existing Memorandum of Understanding (November 20, 1987), a Health Hazard Evaluation of the potential effects of lead in alcoholic beverages (table wine) under the presumption that BATF could take enforcement action if appropriate.

The Center for Food Safety and Applied Nutrition Health Hazard Evaluation Board (HHEB) convened August 5, 1991, to consider the risks to various population subgroups from consumption of "table wines", as described in 27 CFR 4.21(a)(2), containing lead at the levels reflected in the BATF data (Report of Analysis of Wines and Related Products to Determine Lead Content, June 1991) in order to establish levels that present only minimal risk. Although your request was generic for all classes of alcoholic beverages, the HHEB confined its deliberations to table wines, which form the principal focus of your report. It is also the only product class for which we now have adequate data on which to determine consumer exposure. At this point we do not have data indicating that other classes of alcoholic beverages, including beer, sparkling or dessert wines, or spirits, warrant immediate concern.

Of most concern is the fetus, because developmental toxicity phenomena can be causes by low lead levels. The HHEB concluded that the fetus may be harmed by its exposure to the average levels of lead, as reflected in the BATF data, in table wine through its mother's consumption of this beverage. However, because pregnant women are advised not to consume alcoholic beverages, we are preparing a public announcement from the Commissioner of Food and Drugs that underscores the warning that pregnant and lactating women should avoid the consumption of alcoholic beverages.

You require that most wines in the marketplace today bear the following warning:

"According to the Surgeon General women should not drink alcoholic beverages during pregnancy because of the risk of birth defects..."

We recognize that this warning is based upon Congressional concern about the developmental toxicity of alcohol per se; however, we believe the average levels of lead found in table wines also pose a risk for pregnant women. We think that the current warning would be sufficient to address the potential hazards to the fetus from exposure to both alcohol and lead.

The HHEB determined that the daily intake of table wine containing 150 ppb or less of lead is likely to pose no more than a minimal risk to the adult population, including women of childbearing age. However, we would have difficulty taking enforcement action against wine containing this level of lead without a regulation. At this time we lack critical information relative to the issue of avoidability and the contribution from other sources of lead, so we believe scientific discussion and consensus should be obtained to determine whether the 150 ppb level, or even some lower level, would be an appropriate regulatory limit for long-term protection of public health. Therefore, FDA intends to initiate rulemaking to establish a regulation that would limit lead in table wine.

FDA believes, however, that your data clearly indicate that there are currently levels of lead in some table wines that may be injurious. We believe that the toxicological evidence would support enforcement action against any table wine that contains more than 300 ppb of lead on the grounds that it may be harmful to consumers. FDA is willing to advise BATF on a case-by-case basis whether a particular product containing more than 300 ppb lead meets the standards for adulteration under the Federal Food, Drug, and Cosmetic Act. The International Organization of the Vine and Wine (OIV), an intergovernmental body representing countries involved in wine production, has also expressed concern about wines with more than 300 ppb lead. The U.S. is a member of this organization. If we take action against table wines bearing lead above 300 ppb, at least in the short run, the population will be afforded protection from a significant risk from table wines while, at the same time, allowing us to enter the rulemaking process to set a limit.

As you know, a recognized source of potential contamination of wine with lead occurs through the use of lead foil capsules on wine containers. FDA is moving to eliminate this source of lead. We are reviewing a draft Federal Register document that will propose to ban the use of lead capsules. We hope to publish this document in the near future.

In Summary:

1. We are advising that we believe that the available evidence would support regulatory actions against table wines containing lead at greater than 300 ppb. We are willing to advise you on a case-by-case basis in this regard. Representative samples should be collected and analyzed by your in situ procedure; and,

2. Because actions against violative table wines may involve recalls, any recall should be conducted consistent with your draft recall procedures as a Class II recall. Please consult with us on the level of recall and need for publicity in any given situation.

The HHEB evaluation of lead in table wine is enclosed. We hope this information is helpful. Please let us know if you have any questions.

Enclosure