Table of Contents
FDA Consumer magazine
May-June 2000

FDA Takes Action To Enforce The Law

By Tamar Nordenberg

Fiscal year 1999 was a year of public health protection milestones for Food and Drug Administration law enforcers in the agency's Office of Regulatory Affairs, including its criminal investigations arm.

FDA's Office of Criminal Investigations (OCI) arrested 373 suspected violators of public health laws and won 211 court convictions in fiscal year 1999, establishing new records for that 7-year-old office. The total money value in fines and goods forfeited in OCI's cases in fiscal year 1999 amounted to a record $56 million-plus.

One OCI case stood out last year as one of the first criminal prosecutions under the Mammography Quality Standards Act, and the first such prosecution in the state of Virginia. Clifton R. Livesay, president of Shenandoah Valley Mobile X-ray Inc., Woodstock, Va., was sentenced in September 1999 to a term of 18 months in prison and fined $3,000 for performing illegal mammograms without the required FDA certification.

OCI investigators found that Livesay continued to perform mammography exams for about two years after the American College of Radiology denied his company accreditation in December 1996, using a fabricated certificate that represented his company as being properly accredited.

Some other landmark OCI cases have been covered in recent issues of FDA Consumer:

• Fresh Cargo Handling Co. Inc. and Kenbourne International Inc. (March-April 2000 issue): Two Miami seafood importers were fined $650,000 in one of the largest-ever cases of fraudulent misrepresentation of seafood.
• Kenneth Thiefault and Mardel Barber, formerly of Jupiter, Fla. (November-December 1999 issue): The couple received prison sentences of more than eight years between them and were fined a total of more than $100,000 for illegally distributing ozone generators with claims that they could cure a variety of diseases.
• Genentech Inc., South San Francisco, Calif., (September-October 1999 issue): One of the world's largest biotechnology corporations paid $50 million in criminal and civil fines to settle charges that it illegally promoted the growth hormone Protropin for unapproved uses.
• Lawrence "Larry" Greene, Los Banos, Calif. (July-August 1999 issue): Greene was sentenced to more than five years in prison for selling unapproved HIV home test kits over the Internet, as well as through phone solicitations.
• Robert Fiddes, M.D., former owner of SCRI, Whittier, Calif. (May-June 1999 issue): The clinical investigator and then-owner of a California research company was sentenced to 15 months in prison and ordered to repay $800,000 to companies who paid for his laboratory's research results, which were falsified.

While the Office of Criminal Investigations focused on curbing criminal violations of public health laws, other parts of FDA's Office of Regulatory Affairs pursued civil remedies against violators.

Last fiscal year, the Office of Regulatory Affairs' staff of just over a thousand consumer safety officers and investigators conducted more than 15,000 inspections nationwide of facilities that produce, warehouse, or distribute food and medical products.

Repeated findings of noncompliance against one company resulted in a consent decree in which the company agreed to pay an unprecedented civil penalty of $100 million. (See "Manufacturing Misdeeds Cost Abbott Record-Breaking Payment.")

The accompanying chart provides a numerical summary of FDA's enforcement actions in fiscal year 1999. The year saw a previously unequaled volume of products recalled. One notable recall involved frozen mamey (a tropical fruit) sold under the "El Sembrador" and "La Fe" brands. The products' marketers undertook the recall in March 1999 after the frozen mamey was linked to 13 cases of typhoid fever, a bacterial infection that is rare in the United States and can cause serious symptoms such as high fever, abdominal cramps, loss of appetite, and fatigue.

Out-of-compliance blood products accounted for nearly a third (1,295) of the total 3,736 recalls. This high number reflects FDA enforcement actions against those who violate FDA's protective system of overlapping safeguards for blood products--those whose products present a potential risk, whether or not the products turn out to constitute an actual health hazard.

Medical devices accounted for the second-highest number of recalled products--1,263--a number that topped by almost 30 percent the average over the past 10 years.

Medical devices also made up a third of the 41,474 import shipments detained in fiscal year 1999 to stop them from reaching American consumers. A majority of the remaining detentions (about one-half of the total) consisted of food items, mostly fresh produce.

Of the standout enforcement results last year, FDA Associate Commissioner for Regulatory Affairs Dennis Baker says, "The improvement in our enforcement efforts reflects our commitment to protecting consumers from unsafe food and medical products."

Terms of Enforcement

Recall (or field correction):

Action taken by a firm to remove a product from the market (or to correct a problem at the product's location). Recalls may be conducted on a firm's own initiative, by FDA request, or in some cases by FDA order under its legal authority. A Class I recall involves the most serious risk to users, a Class III recall the least serious.

Warning Letter:

An informal written advisory to a firm, communicating FDA's position on a matter but not committing the agency to take enforcement action.

Seizure:

An action to remove a violative product from the market by requesting a court to direct a U.S. Marshal to take possession of goods until a matter is resolved.

Injunction:

A civil action taken against an individual or company to stop production or distribution of a violative product.

Prosecution:

A criminal action taken against a company or individual, charging violation of the law.

--T.N.

Enforcement Numbers

Facility inspections and follow-up enforcement actions, both civil and criminal, complement the agency’s premarket approval procedures in keeping potentially unsafe products from reaching American consumers and ensuring fair competition among regulated companies.

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