Food Drug & Devices – May 2010

Topic of the Month: In response to last year’s enactment of the Tobacco Control Act (Public Law 111-31; 123 Stat. 1776), the FDA published a number of documents regulating or clarifying concerns.  Exceptions for outdoor tobacco advertisement regulations enforcement, set to begin June 22, 2010, were issued in order to allow the agency more time to receive comments from affected parties. Although the regulations concerning outdoor tobacco advertisements are on hold, the agency has not indicated that it would abate work on the matter.

I. Agency Developments


2010 regulatory agenda addresses food safety

The semiannual agenda for all federal agencies was made available on April 26, 2010, including the FDA’s agenda, which lists agency proposals, guidance plans, and completed actions. The agenda provides summarized information about regulatory actions under consideration by the FDA for public review. The agenda focuses primarily on the areas of work expected to result in proposals or final rules within the next 12 months. Some of the regulatory actions listed in the summary include: (1) proposed and final rules encompassing over-the-counter (OTC) drug reviews and labeling changes; (2) a proposed rule on produce safety regarding production and packing; (3) a final rule on infant formula good manufacturing practices; and (4) long-term action on OTC drugs and good manufacturing practices in packaging or labeling of dietary supplements. Public comments may be directed to the agency officials cited in each of the summaries. The portion of the regulatory agenda regarding FDA activities appears at ¶40,013.

II. Drug and Biologics Developments

Enforcement of tobacco products advertisement clarified

Enforcement policies of the final regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents were clarified in a guidance published by the FDA. Titled “Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco, “the document discusses the FDA’s policies with respect to the two provisions promulgated in a Final Rule (75 Federal Register 13225, ¶40,397).

The first provision restricts the use of a trade or brand name of a non-tobacco product as the trade or brand name for a cigarette or smokeless tobacco product. While it considers comments to the regulations, the agency will exercise its enforcement discretion and not commence enforcement actions when: (1) the trade or brand name of the cigarettes or smokeless tobacco product was registered, or the product was marketed, in the United States on or before June 22, 2009; or (2) the first marketing or registration in the United States of the tobacco product occurs before the first marketing or registration in the United States of the non-tobacco product bearing the same name; provided, however, that the tobacco and non-tobacco product are not owned, manufactured, or distributed by the same, related, or affiliated entities, including as a licensee.

In the second provision, effective June 22, 2010, labels and print advertisements must appear in a black-and-white text-only format, except in “adult only” locations or in publications that do not have significant readership by children and adolescents under the age of 18. Following an order of the United States District Court for the Western District of Kentucky permanently enjoining the agency from enforcing this provision, the FDA will suspend enforcement, irrespective of whether the entity is a party to the pending lawsuit or located in the Western District of Kentucky, until the litigation has been resolved. FDA Notice, ¶42,023

Tobacco health document submission; guidance published

Assistance to persons making document submissions to the FDA under the Family Smoking Prevention and Tobacco Control Act was provided in a guidance. Titled “Tobacco Health Document Submission” the guidance provides information on who should submit documents and what should be included. The FDA had previously announced that the statutorily mandated initial document deadline of December 22, 2009 for the submission of documents will not be enforced provided documents are submitted by April 30, 2010. At that time the FDA will enforce the submission requirements with respect to: (1) manufacturers and importers of cigarettes, smokeless tobacco and roll-your-own tobacco for consumers; and (2) manufacturers and importers of tobacco, filters, papers and pouches. In the beginning the FDA will focus on only enforcing the submission of documents in the possession, custody or control of the manufacturer. All documents must be organized and labeled, and all marketed tobacco products must be referred to by their unique commercial name. Documents may address more than one product, constituent or ingredient and must identify the document as it relates to all relevant terminology. Identification numbers assigned to the manufacturer or importer must be part of the submission along with: (1) a corporate email address to facilitate correspondence with the FDA; and (2) a Data Universal Numbering System number or other unique identifier of a business entity. Metadata should also be submitted to accompany the documents and provide structure and context for the information contained in the documents. The guidance finalized a December 2009 draft guidance of the same title. FDA Notice, ¶42,018

III. Food Developments


Water contamination guidance published

A direct and final guidance titled “Guidance for Industry: Use of Water by Food Manufacturers in Areas Subject to a Boil-Water Advisory” has been published by the FDA in response to the recent major water pipe break in Massachusetts that interrupted service to 30 Massachusetts Water Resources Authority customer communities (serving approximately 2 million residents). The guidance is intended to advise food manufacturers that once a boil-water advisory has been issued they should stop using the water subject to the advisory until the water again meets the applicable Federal and State drinking water quality standards. According to the FDA, in cases where water subject to the advisory was used as an ingredient in food or as process water (and the food was not heat treated by the food manufacturer), the product may present a risk to the consumer and should not be distributed unless the FDA, in consultation with the state regulatory authorities, determines that the risk is minimal and can be controlled with ordinary consumer cooking practices. In the interim, the FDA recommends quarantining the food in question until such determination has been made. FDA Notice, ¶42,024

IV. Device Developments

Pediatric devices premarket approval amended

The regulations on premarket approval of medical devices will be amended by the FDA under a Direct Final Rule to include requirements relating to the submission of information on pediatric subpopulations (neonates, infants, children and adolescents) that suffer from the disease or condition that a device is intended to treat, diagnose, or cure. The direct final rule will help the FDA track the following information that it is required to report annually to Congress: (1) the number of approved devices labeled for use in pediatric patients; (2) the number of approved pediatric devices that were exempted from a review fee under section 21 USC §379j(a)(2)(B)(v); and (3) the review time for each device.

The requirements apply to the following applications when submitted on or after the effective date of this proposed rule: (1) humanitarian device exemptions; (2) premarket approval application (PMA) or supplement to a PMA; and (3) product development protocols. Applications that are missing any of the required information will not be eligible for approval by the FDA. A companion proposed rule will provide a procedural framework to finalize the rule in the event the FDA receives significant adverse comment and withdraws the direct final rule. The direct final rule is effective on August 16, 2010. FDA Direct Final Rule, ¶16,882; FDA Proposal, ¶11,886

Electronic submission of registry information proposed

Device registration and listing would be submitted electronically to facilitate the government’s collection of additional information mandated by the Bioterrorism Act under a proposed rule by the FDA. According to the agency, its development of a system for electronic receipt has enabled foreign owners and operators of devices to submit registration and listing information electronically, making the overall process of submitting registration and listing information more efficient. Thus, under the proposed rule, each foreign establishment that is required to register would supply information, including: (1) all importers known to the foreign establishment and (2) the name of each person who imports or offers to import the foreign establishment’s device into the United States. A foreign establishment’s U.S. agent’s responsibilities would include: (1) helping the FDA communicate with the foreign establishment; (2) responding to questions concerning the foreign establishment’s devices; and (3) helping the FDA schedule inspections. Additionally, the agency noted it would not expect to grant waivers to the requirement, because the business expenses associated with owning a personal computer, obtaining an e-mail address, and subscribing to Internet access were low. FDA Proposal, ¶11,885