Fiscal Year 2001

Forward

The FDA Modernization Act of 1997 (PL 105-115) affirmed FDA's public health protection role and defined the Agency's mission:

1. To promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner;
2. With respect to regulated products, protect the public health by ensuring that foods are safe, wholesome, sanitary, and properly labeled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labeled, and; public health and safety are protected from electronic product radiation;
3. Participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and,
4. As determined to be appropriate by the Secretary, carry out paragraphs (1) through (3) in consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors and retailers of regulated products.

The Enforcement Story attests to the Agency’s vigilance in ensuring the safety and purity of all the products that FDA regulates. The importance of FDA’s vigilance in keeping FDA-regulated products safe, effective, and available was highlighted by the events of September 11th.

Since September 11th, FDA has increased its emergency response capability by realigning resources for possible use to counter terrorism, and by reassessing and strengthening its emergency response plans. The Agency also continues to work closely with other federal, state, and local food safety authorities and with regulatory agencies abroad to maximize coordination of efforts to protect food and to respond rapidly to evidence of threats to the food supply. (1)

Among the many unique issues confronting us, following reports of inhalation anthrax incidents this past Fall, FDA took steps to protect consumers from unscrupulous firms who attempted to exploit people’s fears by promoting unapproved and fraudulent products. The Agency investigated hundreds of websites promoting products claiming to offer protection against various biological threats. Many products were promoted via the Internet from overseas. Because FDA cannot provide adequate assurance that drug products ordered from foreign websites are the same product(s) approved by FDA, the Agency asked U.S. Customs to detain entries of Cipro (ciprofloxacin) from foreign firms. In addition to these detentions, FDA issued "cyber" Letters to foreign firms advising them that FDA is taking steps to block the entry of the drug product, ciprofloxacin, into this country.

The Enforcement Story documents FDA’s continuing efforts to meet the challenge of protecting the health of the American people and the safety of FDA-regulated products.

While The Enforcement Story describes examples of noncompliance by only a fraction of regulated industry, the vast majority of industry share FDA’s commitment to the health and safety of the public and produces high quality, reliable products.

PURPOSE:

The information contained in this publication was obtained from many sources within the FDA throughout the course of the fiscal year and updated to the time of publication. While reasonable steps were taken to assure the information was correct at the time of publication, the statements in the publication may not contain all significant information on any cited account.

Further, this publication does not include all enforcement actions undertaken by the FDA during the fiscal year. All items are presented in a summary form to convey the significance of the violation and /or court decision(s). The Enforcement Story is devoted to practical presentation of actual FDA enforcement actions that impact on the development, manufacture, distribution and marketing of foods, drugs, biologics, cosmetics and medical devices.

The Enforcement Story is intended as an internal publication to serve as an information source for the FDA’s personnel. The statements made herein are not intended to create or confer any rights, privileges, or benefits on or for any private person, but are intended merely for internal guidance.

DISTRIBUTION WITHIN THE FDA:

FDA personnel may obtain copies of The Enforcement Story by contacting the Division of Compliance Policy (HFC-230) in the ORA’s Office of Enforcement.

PUBLIC DISTRIBUTION:

The public may obtain a copy of The Enforcement Story by making a written Freedom of Information request.

COMMENTS:

Any comments as to how this annual publication may be improved are welcomed. Please send your comments to the Director, Division of Compliance Policy (HFC-230), 5600 Fishers Lane, Rockville, MD 20857.

1. “Frequently Asked Consumer Questions About Food Safety and Terrorism,” Center for Food Safety and Applied Nutrition, FDA, November 15, 2001.