TABLE WINES FOUND TO CONTAIN LEAD
Wine Premises Proprietors, Wholesalers, Importers, and Others
Purpose. The purpose of this circular is to advise wine
premises proprietors, wholesalers, importers, and others concerned
that the Federal Food and Drug Administration (FDA) has announced
that there may be some risks and potential health effects due to
lead in table wines. FDA has advised ATF that they believe
available toxicological evidence supports regulatory action
against any table wine containing over 300 parts per billion (ppb)
lead. FDA also stated that it is willing to advise ATF on a
case-by-case basis whether a particular table wine containing more
than 300 ppb lead meets the standards for adulteration under the
Federal Food, Drug and Cosmetic Act.
Background. In 1989, ATF began testing various beverages for
the purpose of determining to what extent, if any, lead is
present. Over 600 samples of products, including juices, wines,
non-alcoholic malt beverages, wine coolers, and spirits were
analyzed. Although the range of lead in the samples was
extensive, only 3 of 117 American table wines tested and only
14 of 435 imported table wines tested were found to have over
300 ppb lead.
The FDA is responsible for establishing safe levels of lead in
food products, including alcoholic beverages. ATF submitted to
FDA the results of the laboratory tests on the products tested for
lead content and asked FDA what, if any, health risk was involved
with the levels of lead found in such samples.
ATF was advised that FDA's Health Hazard Evaluation Board (HHEB)
determined that, because of developmental toxicity phenomena, the
fetus is of mast concern. FDA included lactating mothers as a
concern and stated that the Commissioner of FDA is preparing a
public statement that underscores the warning that pregnant and
lactating women should avoid the consumption of alcoholic
A health warning statement alerting pregnant women has been
required on all alcoholic beverage containers bottled on or after
November 18, 1989, for sale or distribution in the United States.
This warning statement specifically states that "According to the
Surgeon General, women should not drink alcoholic beverages during
pregnancy because of the risk of birth defects." Nearly all table
wine sold or distributed in the United States was bottled on or
after November 18, 1989, and therefore, contains a health warning
statement which, if followed by consumers, sufficiently addresses
the potential hazards to the fetus from exposure to both alcohol
The HHEB further determined that lead levels above 300 ppb may be
harmful to consumers and therefore, FDA, upon request, will
evaluate such table wines on a case-by-case basis to determine
whether they are adulterated under the Federal Food, Drug, and
Cosmetic Act. The HHEB specifically confined its deliberations
concerning lead to table wine because the HHEB only had adequate
data on such wine on which to determine consumer exposure. While
there are many classes of wine available to consumers, table wine
represents by far the largest percentage of wines consumed.
Therefore, while other wines are of concern, any recommended
action by FDA, due to the lack of data, will be necessarily
confined to table wines. FDA also intends to initiate rulemaking
to establish a regulation that would limit lead in table wine.
Enforcement Action By ATF. ATF will begin taking
representative samples of American and imported table wines for
laboratory analysis to determine the lead content of such wines.
FDA has advised ATF that they believe 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. ATF will also keep FDA informed of testing results of
all alcoholic beverages found to contain lead. If FDA, after
rulemaking, takes regulatory action on lead level limitations for
alcoholic beverages, ATF will undertake similar rulemaking.
Testing By Proprietors. ATF anticipates that proprietors who
produce and bottle American wines and proprietors who import wines
will want to test representative samples of their wines to
determine the presence of lead and take necessary action to
prevent the introduction into commerce of any wine with over 300
ppb lead. If proprietors do not have the laboratory equipment to
test their wines for lead and would like to know where such a test
can be done, each ATF Area Office has a list with several
commercial laboratories that have indicated they can test for lead.
Inquiries. Inquiries concerning this circular should refer to
its number and be addressed to: Associate Director (Compliance
Operations), Bureau of Alcohol, Tobacco and Firearms,
650 Massachusetts Avenue, NW, Washington, DC 20226.