From Psyllium Seeds to Stoneware: FDA Insures Quality of Imports : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

When Products Fail Standards

When an import fails to meet FDA standards, the importer is given an opportunity to bring the article into compliance through reconditioning or relabeling. In some cases the imports must simply be reexported or destroyed by the importer.

Perishable products such as fresh fruit, vegetables and seafood that could spoil on the docks are given priority handling, with samples collected and examined by FDA laboratories within 24 to 36 hours.

Imports that consistently violate FDA laws or regulations or are a known or suspected health hazard are subject to automatic detention. For example, the diet supplement L-tryptophan is being automatically detained because it has been linked to eosinophilia-myalgia syndrome, a blood disorder.

Other imports under automatic detention include: swordfish from all countries because it repeatedly has been found to contain high levels of mercury; canned mushrooms from the People's Republic of China because they have caused several outbreaks of staphylococcal food poisoning; and, most recently, European wines that were found to contain the fungicide procymidone, which is approved for use on grapes in Europe but not in the United States. As of July 1990, 106 products were on FDA's automatic detention list.

Drugs entering the country must be approved products from an approved supplier and must be listed with FDA. In addition, they must meet U.S. purity and strength requirements. When commercial shipments of drugs enter a port, they are randomly checked and sampled by FDA. On the wharf, inspectors check labels and look for signs of possible contamination, such as cracked vials and broken bottles. As with other imports, potential problem drugs are targeted in advance for sampling and detention.

Exceptions for Personal Use

In special cases, noncommercial drugs and other products not available domestically and not approved by FDA may, at the discretion of the agency, be released for personal use. Sometimes these are recognized drugs for people with severe illnesses, such as cancer or AIDS, that are available in other countries but have not yet been approved in the United States.

To qualify for importation under the agency's personal use policy, a drug must meet the following criteria:

• The drug must have no known health risk.
• It must be for personal use only (generally not more than a three-month supply).
• It must not be promoted commercially to people living in the United States.

Blumberg fondly recalls one personal use exemption he handled while a compliance officer in FDA's Baltimore office:

"There are a lot of quack products promoted through the mail that supposedly prevent aging or rejuvenate people. They're obviously questionable, and we stop them from entering the country whenever we can.

"One day I got a call from a man claiming to be in his '90s. We had stopped a shipment of his anti-aging 'medicine' which he swore worked wonders. Ever since he'd started using KH3, he said, he'd felt like 70. His doctor approved of his using it, he said.

"We contacted his doctor, and, sure enough, his doctor had no problems with his using it and said it had not had any adverse effects."

This was clearly a case requiring FDA's discretion. Blumberg decided to let the man keep his Fountain of Youth.

"Why tell him it was a fraud and didn't work?" asks Blumberg. "For him, in his mind, it clearly worked."

Other personal use requests are not so happily concluded. Blumberg recalls with regret having to turn down the request of a man who had imported some unidentified, unlabeled "medicine" in hopes of prolonging the life of his wife, who was dying of cancer. The man claimed doctors had given her only six weeks to live.

"The man couldn't tell us what was in the drug and he didn't have the consent of his wife's doctor to use it. He was desperate for anything that might have helped her. But as far as we knew, it could have killed her," says Blumberg.

To aid its surveillance of imports, FDA issues import alerts to its district offices. These alerts contain the names and descriptions of products that have repeatedly been found to violate FDA's laws and regulations. The import alert signals FDA inspectors to pay special attention to a particular product when it arrives in port and, in certain cases, to automatically detain it. FDA currently has 237 import alerts on products and foreign shippers.

To further expedite surveillance, FDA enters into voluntary agreements with foreign governments. Through memorandums of understanding (MOUs), these governments agree to make sure products from their countries are manufactured under sanitary conditions, meet U.S. requirements for quality, and are tested and sampled in a specific way before leaving their countries. For example, FDA has nine MOUs with countries that export seafood to the United States. These MOUs help insure that the seafood is processed, packaged and shipped in accordance with FDA standards. When seafood from these countries arrives at a U.S. port, it is subject only to routine examination.

FDA is now negotiating other cooperative agreements with major food exporters of 37 countries to obtain information on pesticide use in those countries.

Under certain conditions, FDA also inspects foreign plants to advise them on their manufacturing practices. Foreign inspections may also occur after products have been detained if the manufacturer wants advice on how to produce goods that meet FDA requirements.

FDA goes to great lengths to make sure that products coming into this country comply with the federal Food, Drug, and Cosmetic Act. As a result of the agency's vigilance, American consumers can be reasonably assured that these products are not only safe but meet the same high requirements of domestic products.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.