Stops Two Dietary Supplement Firms From Selling "Cure
5, 2004 - NEWSdial.com)
The Food and Drug Administration (FDA) today announced that Seasilver
USA, Inc., and Americaloe, Inc., of Carlsbad, California, and
their principals, Bela Berkes and Jason Berkes, have signed a
consent decree of permanent injunction in which they agreed to
stop manufacturing and distributing violative products, including “Seasilver” – a
purported cure-all liquid supplement. This action is the culmination
of coordinated efforts by FDA and the Federal Trade Commission
(FTC) to act against the marketing of these violative products.
is yet another example of FDA’s strong commitment to protect
the public from unscrupulous dietary supplement manufacturers
that make unsubstantiated drug claims,” said FDA Commissioner
Mark B. McClellan, M.D., Ph.D.
consent decree gives FDA the authority to order the firm to discontinue
the marketing of and recall any products that violate the law
in the future. The decree also allows for liquidated damages
for any further violations. The liquidated damages provision
of the consent decree requires the companies and their principals
to pay $1,000.00 for each article distributed in interstate commerce
in violation of the consent decree, the retail value of each
lot manufactured in violation of the consent decree, but not
distributed in interstate commerce, and $10,000.00 per day, per
violation for any other violations of the consent decree. The
consent decree was signed on March 8, 2004, by United States
District Judge William Q. Hayes in San Diego, Calif.
consent decree follows a coordinated effort in June 2003 between
the Federal Trade Commission (FTC) and the FDA against Seasilver
U.S.A., Inc., and Americaloe, Inc., their owners, and two of
the companies' principal distributors. On June 16, 2003, at FDA’s
request, U.S. Marshals seized 132,480 bottles of Seasilver, worth
nearly $5.3 million, from Seasilver USA’s San Diego headquarters.
Government’s complaint alleges that, although Seasilver
USA markets Seasilver as a dietary supplement, the companies
promote it on the Internet and in marketing materials sent with
the product as a treatment for “over 650” diseases
including, for example, cancer, heart disease, stroke, diabetes,
hepatitis, arthritis, depression and other diseases. These claims
cause Seasilver to be an unapproved new drug under the Federal
Food, Drug, and Cosmetic Act (FD&C Act). Such claims also
cause Seasilver to be misbranded under the FD&C Act because
it lacks adequate directions for use.
labeling also contains claims such as “cleanses your vital
organs” and “oxygenates your body’s cells.” These
claims show that Seasilver is intended to affect the structure
or function of the body. Because the claims are unsubstantiated,
Seasilver is misbranded under the FD&C Act.
FTC, which regulates dietary supplement advertising, alleges,
in part, that the defendants promoted Seasilver through false
claims that it was clinically proven to treat or cure 650 diseases,
including cancer and AIDS. Under a settlement with the FTC, entered
on March 4, 2004, the Seasilver defendants and the individual
distributors agreed to pay $4.5 million in consumer redress.
In addition, the FTC settlements also bar defendants from making
any false or misleading claims about the benefits of any food,
drug, or dietary supplement.
claims for Seasilver threatened consumers’ health by encouraging
delays and replacements for proven treatments," said Howard
Beales, Director of the FTC's Bureau of Consumer Protection. "The
FTC and FDA are committed to taking aggressive action against
false and unsubstantiated claims in the dietary supplement market.
Products touted as cure-alls almost always cure nothing.”
a result of FDA’s consent decree, Seasilver U.S.A. and
Americaloe, Inc., will destroy the seized products at their expense
under the supervision of a Department of Health and Human Services
representative within 60 days of posting bond.
to April 2004 News Archives