Tougher Rules on Food, Drug Labels

With more than $2 trillion of goods imported into the US from 150 countries each year and 62 recent deaths attributed to tainted heparin coming from China, there is increasing public demand to know where, exactly, their foods, medicines, and medical devices are coming from. In an effort to supply that increasingly important information, the House Energy and Commerce Committee proposed on Thursday that all labels on fresh produce identify the food’s country of origin. They also call for corporate websites that identify the country of origin for each ingredient in any given product.

The committee also wants the labels on drugs to list active ingredients and identify their manufacturer’s location. Medical devices need to identify their country of origin, too.

A draft copy of the proposal will be distributed to lawmakers as well as to representatives of the medical device, drug, and food industries. The committee will host hearings based on the proposal beginning next week.

Rep. John Dingell, D-Mich, chairman of the Energy and Commerce Committee, says American consumers deserve this information and can make educated evaluations on the safety of the products purchased when the country of origin is identified. Using Great Britain, Canada, and China as examples, he feels consumer confidence would remain high for products imported from Great Britain and Canada but caution would be advised before purchasing Chinese imports.

With the added burden this legislation would place on an already over-burdened Food and Drug Administration (FDA), the proposal calls for additional funding by way of new fees paid by all entities inside and outside the US that service this market. The current proposal calls for a fee of $2,000 for each facility that manufactures, distributes, or stores foods, drugs, and medical devices for sale on the US market. If passed, this bill will generate nearly $600 million each year to fund beefed-up FDA inspections.

The proposed legislation calls for inspection of every food-related facility, domestic or foreign, every four years and inspections every two years for facilities working with drugs and medical devices. Refusal to allow US inspection will remove that facility’s products from the US market. To facilitate better foreign oversight, the proposal is written to create a permanent inspection force on foreign soil so inspectors can gain a better understanding of local customs, languages, and the people who operate the companies that import their wares to the US.

A spokesman for the Grocery Manufacturers Association, Scott Faber, says the legislation would only increase the cost of food to consumers at a time when so many Americans are already facing the very real prospect of losing their homes and their jobs.

Jean Halloran, speaking on behalf of the Consumers Union, doesn’t anticipate a significant price increase for consumers and thinks the average American would be willing to pay more if it means a safer food supply.

Current law limits the authority of the FDA where recalls are concerned. Under present law, the FDA can only suggest a company initiate a recall. The proposed legislation would give the FDA the authority to conduct mandatory recalls as it deems necessary. Fabor says grocery manufacturers would support this expanded authority to mandate recalls.

Ken Johnson, representing the Pharmaceutical Research and Manufacturers of America, says his organization has not yet formulated a stance on foreign inspections and the inclusion of country of origin on labels but says that the FDA, saddled with a soaring list of responsibilities, does need more funding as current avenues of funding have not been able to meet demand.

Filed under: Diet, FDA, Prevention, Recalls