Federal Authorities Seize More Than $100,000 of Unapproved Drugs Marketed as "Natural Supplements"
Products contain active ingredients in prescription erectile dysfunction drugs
At the request of the U.S. Food and Drug Administration, today U.S.
Marshals seized more than 14,000 dosage units of Shangai Regular,
Shangai Ultra, Super Shangai, Naturalë Super Plus, and Lady Shangai.
Although labeled as natural supplements, the seized products were all
marketed to treat erectile dysfunction (ED), impotency, and/or to
provide sexual enhancement, which caused them to be drugs under the
Federal Food, Drug, and Cosmetic Act.
The seized products, valued at more than $100,000, contain
undeclared active ingredients found in FDA-approved prescription drugs
for ED, or similar substances. Use of these products may result in
serious side effects and may interact in dangerous ways with
medications that a consumer may already be taking.
“The FDA will not tolerate companies marketing unapproved drugs --
products that have not proven to be safe or effective -- as dietary
supplements," said Margaret O'K. Glavin, associate commissioner for
regulatory affairs. “The agency will pursue necessary legal action to
make sure companies and their executives manufacture and distribute
safe drug products."
The seized products, which originated in China, are packaged and
distributed by Shangai Distributors, Inc. of Coamo, Puerto Rico.
Although the products' labels state they are natural supplements, these
products are drugs and their sale is illegal without FDA approval.
Before a new drug product may be legally marketed, it must be shown to
be safe and effective.
In response to a consumer complaint, the FDA conducted an inspection
of Shangai Distributors Inc., in November 2007. The FDA's investigation
and testing revealed that the seized products contained active drug
ingredients found in FDA-approved ED prescription drugs and/or a
substance with a structure similar to such drugs that may cause similar
side effects and drug interactions. None of the drug ingredients are
listed on the labels of any of the seized products.
The undeclared ingredients in these products may interact with
nitrates found in some prescription drugs (such as nitroglycerin) and
can lower blood pressure to dangerous levels. Consumers with diabetes,
high blood pressure, high cholesterol, or heart disease often take
nitrates. ED is a common problem in men with these medical conditions.
Because they may have been advised against taking ED drugs, they may
seek out products like these because they are marketed as “all natural"
or as not containing the active ingredients in approved, prescribed ED
drugs. Additionally, because the manufacturing source of the active
ingredients in these products is unknown, consumers should be aware
that the safety, efficacy, and purity of these ingredients can not be
validated.
Despite being advised of the findings and the potential adverse
health risk posed by the seized products and that regulatory action was
possible, the company did not take any action to correct the
violations. The FDA issued a press release on December 28, 2007
advising consumers not to buy or use the products. Prior to the
seizure, the Puerto Rico Department of Health embargoed the seized
products to protect the citizens of Puerto Rico and to support the
FDA's enforcement actions.
The FDA advises consumers who have used any of these products to
discontinue use and consult their health care providers if they have
experienced any adverse events that they believe are related to the use
of these products. Consumers and health care professionals can report
adverse events to FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.
FDA recommends that consumers talk to their health care provider about
FDA-approved treatments for erectile dysfunction. FDA may take further
regulatory actions to protect consumers from these illegal products.
The complaint was filed by Assistant U.S. Attorney Jose M. Pizarro,
deputy chief, Civil Division, United States Attorney's Office, District
of Puerto Rico.
Released April 9, 2008
