Regulatory Updates

Distribution date: 04 September 2006

The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking that would establish that over-the-counter (OTC) skin bleaching drug products are not generally recognized as safe and effective (GRASE) and are misbranded. FDA is also withdrawing the previous proposed rule on skin bleaching drug products for OTC human use, which was issued in the form of a tentative final monograph (TFM). FDA is issuing this proposed rule after considering new data and information on the safety of hydroquinone, the only active ingredient that had been proposed for inclusion in a monograph for these products. This proposal is part of FDA's ongoing review of OTC drug products. Further, upon issuance of a final rule, FDA intends to consider all skin bleaching drug products, whether currently marketed on a prescription or OTC basis, to be new drugs requiring an approved new drug application (NDA) for continued marketing.

Products Covered: Skin bleaching drug products (HS:  Chapter 3004;  ICS:  11)

Regulation Type: Regular notification

Distribution date: 31 August 2006

FDA issued proposed regulations to implement section 572 of the Federal Food Drug and Cosmetic Act entitled "Index of Legally Marketed Unapproved New Animal Drugs for Minor Species." These regulations propose administrative procedures and criteria for index listing a new animal drug for use in a minor animal species. Such indexing provides a basis for legally marketing an unapproved new animal drug intended for use in a minor animal species in the United States.

Products Covered: Animal drugs

Regulation Type: Regular notification

Distribution date: 31 August 2006

FDA issued proposed regulations to implement section 572 of the Federal Food Drug and Cosmetic Act entitled "Index of Legally Marketed Unapproved New Animal Drugs for Minor Species." These regulations propose administrative procedures and criteria for index listing a new animal drug for use in a minor animal species. Such indexing provides a basis for legally marketing an unapproved new animal drug intended for use in a minor animal species in the United States.

Products Covered: Animal drugs

Regulation Type: Regular notification

Distribution date: 24 August 2006

Products Covered: Tomato products (HS:  200210;  ICS:  67.080.20)

Regulation Type: Regular notification

Distribution date: 24 August 2006

Products Covered: Tomato products (HS:  200210;  ICS:  67.080.20)

Regulation Type: Regular notification

Distribution date: 24 August 2006

Products Covered: Tomato products (HS:  00210;  ICS;  67.080.20)

Regulation Type: Regular notification

Distribution date: 24 August 2006

Products Covered: Tomato products (HS:  00210;  ICS;  67.080.20)

Regulation Type: Regular notification

Distribution date: 24 August 2006

Products Covered: Tomato products (HS:  200210;  ICS:  67.080.20)

Regulation Type: Regular notification

Distribution date: 24 August 2006

Products Covered: Tomato products (HS:  200210;  ICS:  67.080.20)

Regulation Type: Regular notification

Distribution date: 23 August 2006

This rule establishes the standards for affixing labels to mercury-added products, as required under 38 MRSA Section 1662(1). The purpose of this rule is to reduce mercury emissions to the environment through labeling of mercury-added products. Product labeling is expected to reduce mercury emissions by enabling consumers and solid waste workers to readily identify the products so they can be properly managed in accordance with the disposal ban under 38 MRSA Section 1663 and the source separation requirement under 38 MRSA Section 1664.

Products Covered: Mercury-added products (HS:  2805;  ICS:  71)

Regulation Type: Regular notification