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Guidance for Industry and FDA: 1991

Letter to Bureau of Alcohol, Tobacco


and Firearms Regarding Lead in Wine
Contains Non-Binding Recommendations
March 2007
Additional copies are available from:
Office of Food Safety
Division of Plant and Dairy Food Safety, HFS-317
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
(Tel) 301-436-2022
http://www.cfsan.fda.gov/guidance.html
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
March 2007

Contains Non-Binding Recommendations

Guidance for Industry and FDA(1)


1991 Letter to Bureau of Alcohol, Tobacco, and
Firearms Regarding Lead in Wine
This guidance document represents the Food and Drug Administration's (FDA's)
current thinking on this topic. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. You may use an alternative
approach if the approach satisfies the requirements of the applicable statutes and
regulations. If you want to discuss an alternative approach, contact the FDA staff
responsible for implementing this guidance. If you cannot identify the appropriate
FDA staff, call the appropriate number listed on the title page of this guidance.

Table of Contents

I.
II.
III.

INTRODUCTION
BACKGROUND
THE 1991 LETTER

I. INTRODUCTION
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.

II. BACKGROUND
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)).

III. THE 1991 LETTER


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.
Sincerely,
L. Robert Lake
Director
Office of Compliance
Center for Food Safety and Applied Nutrition.

Enclosure
(1)

This guidance has been prepared by the Office of Food Safety (formerly Office of Plant
and Dairy Foods) in the Center for Food Safety and Applied Nutrition at the U.S. Food
and Drug Administration.