FDA Crackdown on Illegal Products

During 2003, the Food and Drug Administration took significant strides to address the growing threat of illegal drugs and false health claims related to dietary supplements. "Our major priority is to continue fostering the legitimate manufacture, sale and use of FDA-regulated products while maintaining a zero-tolerance approach to illegal practices," says John Taylor, the FDA's associate commissioner for regulatory affairs. "We're working to allocate resources in a way that maximizes our impact on public health."

Here are some examples of recent actions by the agency:

Warnings on imported drugs: The FDA has long been concerned about the dangers faced by consumers who buy medications outside of the United States. During the fall of 2003, the FDA issued warnings and filed complaints against Rx Depot of Lowell, Ark., and CanaRx Services of Detroit to stop them from importing drugs from Canada. The FDA considers these operations illegal and dangerous.

CanaRx made misleading assurances to consumers about the safety of its drugs. An FDA investigation of CanaRx showed that the firm does not consistently use shipping practices necessary to ensure its drugs are safe and effective. For example, the FDA collected evidence demonstrating that CanaRx shipped insulin that hadn't been properly stored. In another case, an FDA investigator bought a prescription antidepressant drug called Serzone (nefazodone) from Rx Depot. The prescription called for 60 pills, with instructions for one pill to be taken twice a day for 30 days. But the investigator received 99 pills of APO-Nefazodone, an unapproved, foreign-manufactured version of Serzone's active ingredient.

Illegal claims on dietary supplements: In November 2003, the FDA announced that NBTY Inc. of Bohemia, N.Y., had destroyed about $3 million worth of Royal Tongan Limu, a dietary supplement that had been promoted to treat cancer, arthritis, attention deficit disorder, and other conditions. The supplements were distributed by Dynamic Essentials, an NBTY subsidiary in Lake Mary, Fla. After an FDA investigation of the firm's New York and Florida locations, Dynamic Essentials decided to cease operations and destroy the product.

In October 2003, the FDA announced it had entered a consent decree of permanent injunction against several corporations, including Hi-Tech Pharmaceuticals, National Urological Group, National Institute for Clinical Weight Loss, American Weight Loss Clinic, and United Metabolic Research Center to prevent the sale of unapproved and misbranded products. The defendants repeatedly sold dietary supplements that made false claims about treating obesity and erectile dysfunction.

"Getting rid of these products underscores the message from FDA to those who would mislead consumers about their health," says FDA Commissioner Mark B. McClellan, M.D., Ph.D. "We will not tolerate companies that raise false hopes for preventing and treating illnesses, when there are more scientifically proven steps than ever before that consumers can take to improve their health."

Drugs seized from repackager: In September 2003, the FDA seized all drug products labeled in a foreign language and/or repacked by Alliance Wholesale Distributors and Local Repack in Richton, Ill. The FDA's inspections of Local Repack revealed that the company failed to report customer complaints to the FDA and failed to maintain complete records, along with numerous other deficiencies. The FDA determined that many of the products at Local Repack were of unknown origin, and their storage and handling conditions were unverifiable.

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Import Blitz Reveals Safety Concerns

Mail shipments of foreign drugs to U.S. consumers often contain dangerous, unapproved or counterfeit drugs, according to two "blitz exams" conducted by the Food and Drug Administration and U.S. Customs and Border Protection (CBP).

Import blitz exams are targeted examinations of parcels at a select number of mail facilities over a specific time. The exams help the FDA understand trends in the illegal importation of unsafe drugs, target future shipments and sources of such drugs, and seek partnerships with other federal, state and international partners to combat the problem.

Generally, due to the huge volume of parcels entering the United States, the FDA and CBP don't have sufficient resources to perform comprehensive examinations of all mailed packages. Through review of historical data and experience, FDA and CBP personnel are able to identify parcels likely to contain imported drug products.

One round of blitz exams was conducted last summer in mail facilities in Miami, New York City, San Francisco, and Carson, Calif. Of the 1,153 imported drug parcels examined, 88 percent contained unapproved drugs from many countries.

Here are some examples:

Drugs different from those approved by the FDA: Roaccutane, an unapproved version of the acne drug Accutane (isotretinoin), was imported into the United States from Thailand. Taro-warfarin, an unapproved version of warfarin, was imported from Canada. Warfarin is used to prevent blood clots.
Drugs requiring careful dosing: Inspectors discovered unapproved versions of Dilantin (phenytoin) from the Philippines, unapproved versions of Synthroid (levothyroxine) from Canada, and unapproved versions of Glucophage (metformin) from Canada and the Philippines.
Drugs with inadequate labeling: Most of the drugs came without adequate labeling or instructions for proper and safe use. Some of the drug labeling was not in English.
Drugs inappropriately packaged: In some cases, the drugs were in baggies, tissue paper or envelopes. Some drugs arrived crushed or broken.
Drugs withdrawn from the market: Buscapina, an unapproved drug that came from Mexico, appeared to be the pain and fever drug dipyrone. The FDA removed dipyrone from the market in 1977 because of potentially fatal side effects.
Animal drugs not approved for human use: One drug called clenbuterol is banned by the International Olympic Committee as a performance-enhancing drug. Clenbuterol is approved to treat airway diseases in horses, but is not approved for humans.
Drugs with potential for dangerous interactions: Unapproved versions of Viagra (sildenafil) were shipped from the United Kingdom, India, the Philippines and Japan. Unapproved versions of Zocor (simvastatin) came from Canada. These drugs can cause significant interactions with other drugs.
Drugs requiring screening and monitoring: Unapproved versions of the cholesterol drug Lipitor (atorvastatin) came from Ireland, Thailand, Japan, the Philippines, Canada, Argentina, New Zealand, England, and Brazil. Unapproved versions of Pravachol (pravastatin), another cholesterol drug, came from Canada. For both drugs, screening and monitoring of patients' liver function are needed.
Controlled substances: More than 25 different imported controlled substances were referred to the Drug Enforcement Administration.

A second import blitz exam, done in November 2003 at the Buffalo, Chicago, Dallas, and Seattle postal facilities and at the Memphis and Cincinnati courier hubs, found 1,728 unapproved drugs, including so-called "foreign versions" of FDA-approved drugs. The blitz also found recalled drugs, drugs requiring close physician monitoring, and drugs containing addictive controlled substances.

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