A draft version of a revised bill intended to improve the safety of imported foods, drugs, cosmetics and medical devices is being circulated within the House Energy and Commerce Committee. Committee Chairman John Dingell, D-Mich., told committee members in an April 17 memo that he anticipates holding hearings on the draft over the next few weeks and to mark up a bill shortly thereafter. Dingell’s original bill (H.R. 3610) was introduced last September but has been updated to reflect various developments and findings since that time.
According to Dingell’s memo, the draft bill includes the following provisions.
Registration. All food, drug, medical device and cosmetic facilities operating within the U.S. or exporting to the U.S., and all importers of drugs, medical devices, foods and cosmetics (other than for only personal use), would have to register annually with the Food and Drug Administration. The registration fee would be $2,000 per facility for food and cosmetic facilities and $10,000 for importers. Additional fees could be imposed for food facilities if a violation is committed that requires a reinspection by the FDA. Upon registration, each facility and importer would be given a unique identification number.
Import Restrictions. Foreign and domestic food facilities could voluntarily seek certification from FDA-accredited certifying agents, which could include foreign governments. After a phase-in period of at least five years, food from facilities that are not certified could only be shipped through U.S. ports of entry with federal testing laboratories.
Manufacturers would be prohibited from introducing a drug, drug ingredient or medical device into interstate commerce until an initial facility inspection has occurred. After a phase-in period, importers of drugs for commercial use who lack documentation of compliance with requirements related to identity, strength, quality, purity, approval, listing, labeling and registration could only ship products through U.S. ports of entry with federal testing labs.
Expedited Entry. Within two years, the FDA would be required to develop and implement a regulatory program that expedites the movement of food through the importation process provided that each facility involved in the production, manufacture, processing, packaging and holding of the food (a) is certified and (b) has agreed to abide by and has been found in compliance with the food safety and security guidelines developed by the FDA.
Labeling. All processed food labels would have to indicate the country in which final processing occurred. Food manufacturers would be required to identify on their Web sites the countries of origin for all ingredients. Country-of-origin labeling would be mandated for all produce. Meat, poultry and seafood products to which carbon monoxide has been added would have to be labeled with a consumer notice that the freshness of the product should not be judged by its color.
Drug labels would have to identify the source of the active pharmaceutical ingredient and its place of manufacture. Medical device labels would be required to indicate the country of manufacture.
Enforcement. Civil penalties for introducing adulterated food into interstate commerce would be increased to a maximum of $100,000 per individual and $500,000 for other persons. The FDA could also impose fines of up to $100,000 for each violation of drug safety requirements and $150,000 for each instance in which a manufacturer, distributor, importer, broker or filer knowingly reports or enters false data on documents related to the introduction of drugs or medical devices into interstate commerce. In addition, the FDA would be allowed to destroy counterfeit or adulterated commercial drug imports.
The FDA would be given new authority to issue mandatory recalls of tainted foods. The FDA’s current authority to recall and detain dangerous medical devices would be extended to drugs.
The current prohibition against making false or misleading reports related to medical devices would be extended to include food, drugs and cosmetics.
Inspections. Foreign and domestic food facilities would be subject to unannounced inspections every four years. Non-certified food facilities would be inspected every two years and have to meet additional testing requirements. The FDA would be required to inspect foreign and domestic drug and medical device facilities every two years. Refusing, impeding or delaying an inspection would be cause for suspension of registration.
The FDA would be required to establish and maintain a corps of inspectors dedicated to inspections of foreign food, drug, medical device and cosmetic facilities and establishments.
Testing. The FDA would be allowed to accredit third-party labs to perform testing to ensure that food facilities’ process controls are working and that performance standards are being met. Accredited labs would be required to send any test results to the FDA.
Manufacturers of drugs and drug ingredients would be required to test them for contaminants.
Safety Plans. Foreign and domestic food facilities would be required to have safety plans in place to identify and mitigate hazards. These plans would be reviewed by the FDA during mandatory inspections.
Export Certificates. The FDA would be allowed to charge a fee for the issuance of an export certificate for foods and animal fees in situations where exports are restricted without such a certificate.
Cosmetics. All cosmetic facilities would be required to report to the FDA adverse events resulting from the use of their products. They would also have to comply with good manufacturing practices established by the FDA.
FDA Offices. The FDA would be barred from closing or consolidating any of its 13 field labs or 20 district offices.
World Trade/Interactive
