What is the FDA Globalization Act of 2008?

The FDA Globalization Act of 2008 is a proposal that is intended to increase the safety level of food, drugs, drug devices and cosmetics. It would require more stringent and annual registration of food and drug device manufacturers, and includes cosmetic manufacturers in the registration requirements.

A Memorandum of April 17, 2008 was sent to all the members of the Committee on Energy and Commerce, which is the committee that is working on the draft. The Memorandum summarized the cosmetics section as follows:

COSMETIC SAFETY

Create an up-to-date registry of all cosmetic facilities serving American consumers: Require all facilities operating within the US or exporting cosmetics to the US to register with the FDA annually.

Generate resources to support FDA oversight of cosmetics: Registration would require payment of a $2,000 fee per facility.

Require adverse-event reporting: Require all cosmetic facilities to report adverse events resulting from the use of their products to the FDA.

Require compliance with good manufacturing practices (GMPs): Require all cosmetic facilities to comply with good manufacturing practices established by the Secretary of Health and Human Services.

For more details on the actual content of the act, you can read a section-by-section analysis.

How did it come into being?

During the past legislative session there were several bills introduced into the House of Representative dealing with food and drug safety, all of which were referred to the Committee on Energy and Commerce. They were:

• HR 3610 – Food and Drug Import Safety Act of 2007
• H.R.3624 – Consumer Food Safety Act of 2007
• H.R.3115 - Carbon Monoxide Treated Meat, Poultry, and Seafood Safe Handling, Labeling, and Consumer Protection Act
• SAFER Meat, Poultry, and Food Act of 2007

In addition, the Committee had information from:

• Findings from investigations conducted by the Subcommittee on Oversight and Investigations of the Committtee on Energy and Commerce
• Report of the FDA Science Board's Subcommittee on Science and Technology,
• The Administrations Food Protection Plan and Import Safety Plan
• Input from key stakeholders

Obviously, there is attention on the safety of food and drugs used by American consumers.

The Discussion Draft of the FDA Globalization Act of 2008 was built upon the input listed above. It is interesting to note that there is very little mention of “Cosmetics” in any of the issues; one can only assume that cosmetics were added after "input from key stakeholders".

What's happened so far?

The FDA Globalization Act of 2008 is currently in existence as a “Discussion Draft” within the House of Representatives Committee on Energy and Commerce.

Hearings were held on the draft in April and May. Webcasts of the hearings are available for download (very large files) and the papers presented by those at the hearings are available to review.

April 24, 2008 - Subcommittee on Health: "Discussion Draft of the Food and Drug Administration Globalization Act Legislation: Food Provisions"

May 1, 2008 - Subcommittee on Health: "Discussion Draft of the Food and Drug Administration Globalization Act Legislation: Drug Safety"

May 14, 2008 - Subcommittee on Health Hearing: "Discussion Draft of the Food and Drug Administration Globalization Act Legislation: Device and Cosmetic Safety Provisions "

Where does it stand now - and what happens next?

As published on the Committee for Energy and Commerce website, the FDA Act is still in the "Discussion Draft" stage. The next step is for the committee to decide if and how they want to change the draft, so the final result is in the form of an actual bill.

On October 24th, Donna Maria received an email from the Staffer in charge of revisions on the draft. He requested input on proposed revisions. HSMG President, Marie Gale, is working with Donna Maria to present a statement on exactly what revisions we feel should be made. That letter will be sent by October 31. A copy will be posted here when it is finalized.

Once the Committee has made their final decision, it goes to the House of Representatives to be introduced as a new bill and, if passed, become law. It is unlikely that it will be introduced until after the elections and the new Congress gets going after the first of the year.

It is up to us to let our legislators know feelings on the bill so they can take that into account by when amending or voting on the final bill.

For a full explaination of how a bill becomes law, click here for web-page version or click here for pdf version