Food Drug & Devices – June 2010

Announcing the New CCH Health Reform Toolkit

In response to the new health reform laws—Patient Protection and Affordable Care Act and Health Care and Education Reconciliation Act of 2010—Wolters Kluwer introduces the CCH Health Reform Toolkit, a complete suite of electronic workflow tools for navigating and understanding the near 3000 pages of legislation into easy to understand topics related to the hospital, pharmaceutical, and legal industries.

The Toolkit will further keep you abreast of all future Health Reform impact by automatically tracking related amended regulations, rules, new legislation, and primary source documents, providing access to full text documents and weekly email notifications so that you can keep on top of all guidance and changes that the government agencies release.

Features include: easy to navigate topics; search topics using synonyms; plain English summary of law section with links to fully explanatory analysis; links to full text of enacted law, and amended law in place to reflect Health Reform in ERISA, IRC, and SSA; export all results in Excel, Word, or Email; import action item effective dates for Health Reform Effective Date Lookup to Outlook Calendar creating automatic reminders and instructions for compliance; and customizable results show changes made to a topic to reflect new rules, regulations, legislation, and primary source documents during the last 10 days, 30 days, 90 days, and more…

The suite of tools includes what we call Smart Charts for the following topics: Providers, Medicaid, Drugs and Devices, Law Lookup, Effective Date Lookup, Grants Management, Demonstration Projects and New Programs, and Comprehensive—containing every provision in the Health Reform laws.

The CCH Health Reform Toolkit is available with links to the CCH Medicare and Medicaid Guide laws, regulations and explanations, incorporating in industry trusted content with new workflow tools; or as a stand-alone product incorporating in the e-version of the CCH Law, Explanation & Analysis book on these health reform laws.

To learn more about the CCH Health Reform Toolkit, please go to; or contact your local sales rep at 888-224-7377.



Topic of the Month: Last year’s enactment of the Tobacco Control Act (Public Law 111-31; 123 Stat. 1776) granted the FDA the authority to regulate tobacco products, with a special emphasis on preventing their use by children and youth and reducing the impact of tobacco on public health. The Act authorizes the FDA, among other things, to set tobacco product standards, require product listing and registration, revise health warning labels, create mnufacturing standards, and review products intended to modify the risk of tobacco use.

The FDA continued to publish various documents during June in a coordinated effort to reduce death and disease associated with tobacco use.  The agency published various guidances on marketing enforcement, harmful constituents within tobacco products, and sales restrictions.

I. Agency Developments


Expansion of disclosure of agency information proposed

Twenty-one draft proposals on public disclosure policies aimed at helping the public understand how the FDA operates and makes decisions were published for comments by the agency as part of its transparency initiative. In a report titled “FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration,” the agency discusses the expansion of disclosure of information while maintaining confidentiality of trade secrets and individually identifiable patient information. The draft proposals cover topic areas of: (1) adverse event reporting; (2) docket management process; (3) enforcement priorities and actions; (4) import procedures; (5) inspections; (6) product applications; (7) recalls; and (8) warning and untitled letters. The FDA’s transparency initiative task force will recommend specific proposals to the Commissioner, taking into consideration the feasibility and priority of the proposals in relation to the agency’s resources. FDA Notice, ¶43,893

II. Drug and Biologics Developments


Smokeless tobacco rotational marketing enforcement guidance published


As an exercise of enforcement discretion, the FDA will not commence or recommend enforcement of the requirement that a smokeless tobacco manufacturer, distributor, importer, or retailer must have an FDA-approved rotational warning plan, so long as a rotational warning plan has been submitted to FDA by July 22, 2010. Titled “Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco Products, “the guidance provides information relating to the FDA’s enforcement policy concerning the Comprehensive Smokeless Tobacco Health Education Act, as amended by the Family Smoking Prevention and Tobacco Control Act (Public Law No. 111-31). According to the FDA, allowing additional time for the review of rotational warning plans will permit an orderly transition of regulatory authority from the FTC to FDA. During the transition affected companies may contact the FDA to discuss the submission of their rotational warning plans in order to make the subsequent approval process more orderly and efficient. The enforcement policy pertains only to the requirement that smokeless tobacco manufacturers, distributors, importers, or retailers must have an FDA-approved rotational warning plan; and the FDA expects compliance with regard to all other requirements of the Smokeless Tobacco Act, including the requirements relating to size, formatting, location, and use of required warning statements. FDA Notice, ¶42,029



“Harmful constituents” draft guidance published

A draft guidance explaining the meaning of the term “harmful and potentially harmful constituent” as used in Section 904(e) of the FDC Act was published by the FDA. Titled “Harmful and Potentially Harmful Constituents in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act”, the draft guidance discusses the FDA’s determination that the term “harmful and potentially harmful constituent” applies to any chemical or chemical compound that is potentially inhaled, ingested, or absorbed into the body and causes or has the potential to cause direct or indirect harm to users or non-suers of tobacco products. Examples of constituents that have the “potential to cause direct harm” to users or non-users of tobacco products include toxicants, carcinogens, and addictive chemicals and chemical compounds. Constituents that have the “potential to cause indirect harm” include those that may increase the exposure to the harmful effects of a tobacco product constituent by: (1) facilitating initiation of the use of tobacco products; (2) impeding cessation of the use of tobacco products; or (3) increasing the intensity of tobacco product use. FDA Notice, ¶42,032

Compliance with tobacco sale restrictions; draft guidance published

A draft guidance to help small entities comply with the final regulations restricting the sale and distribution of cigarettes and smokeless tobacco in order to protect children and adolescents was published by the FDA. Titled “Draft Guidance for Industry: Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents,” the draft guidance provides information for industry to comply the June 22, 2010, deadline that will: (1) prohibit retailers from selling cigarettes, cigarette tobacco, or smokeless tobacco to individuals under the age of 18; and (2) require age verification of customers under the age of 27, as required by the 2009 Family Smoking Prevention and Tobacco Control Act (Public Law No. 111-31). The draft guidance outlines how to check proof of age, acceptable forms of photo identification, and suggests retailers request identification from customers prior to giving them the requested tobacco product. The draft guidance explains what products are subject to the regulation and what products are not applicable, including cigars and pipe tobacco. FDA Notice, ¶42,030


III. Food Developments

GRAS in animal feed pilot program launched

A voluntary pilot program for an applicant’s notice of claims submission that a particular use of a substance in food for animals is exempt from the statutory premarket approval requirements, because the applicant has determined that such use is generally recognized as safe (GRAS), was announced by the FDA. The FDA will evaluate these notices and inform each applicant in writing within 90 days whether the notice provides a sufficient basis for the GRAS determination, or in the alternative that the FDA has identified questions as to whether the intended use of the substance is GRAS. The applicant may base the GRAS determination through scientific procedures or through experience based on common use in food. For a GRAS determination through scientific procedures, such summary should include a comprehensive discussion of, and citations to, generally available and accepted scientific data, information, methods, or principles that the applicant relies on to establish safety. The summary should explain the probable consumption of the substance and the probable consumption of any substance formed in or on food because of its use and the cumulative effect of the substance in the diet. FDA Notice, ¶43,898

Reportable Food Registry Q & A draft guidance issued

A draft guidance that provides information to the industry on complying with the Reportable Food Registry (Registry) requirements was published by the FDA. Titled”Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2), “the draft guidance addresses inquiries the FDA has received through its Registry help desk since the implementation of the Registry in 2009. The draft guidance also provides information on the new Safety Reporting Portal and clarifies that while the Registry portal is only available in English, the FDA would make its guidance documents regarding the Registry available on the Reportable Food Registry web page in Spanish, French, and Chinese. The draft guidance also clarifies that manufacturers, packers or distributors whose names appear on the label of a dietary supplement marketed in the United States must submit any report received of a serious adverse event associated with that dietary supplement when used in the United States, accompanied by a copy of the dietary supplement’s label to the FDA. The first edition of questions and answers clarified key issues regarding information entry into the registry such as how, when, and where to submit reports to FDA. FDA Notice, ¶42,025

IV. Device Developments

513(g) information requests guidance published

Recommendations to FDA staff and medical device manufacturers were published in a draft guidance by the FDA in reference to section 513(g) of the FDC Act, which describes the means for obtaining the FDA’s views about the classification and the regulatory requirements that may be applicable to a particular device. Titled “Draft Guidance for Industry and FDA Staff; FDA and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act,” the draft document provides information to both FDA staff and industry on (1) the procedures for submitting, reviewing, and responding to requests for information respecting the class in which a device has been classified and (2) the requirements applicable to a device under the act that are submitted in accordance with section 513(g) of the FDC Act. According to the draft document, the FDA will not review data related to substantial equivalence or safety and effectiveness in a 513(g) Request for Information. The FDA’s responses to 513(g) Requests for Information are not device classification decisions and do not constitute the FDA’s clearance or approval for marketing. Therefore, classification decisions and clearance or approval for marketing would require submissions under different sections of the FDC Act. FDA Notice, ¶19,547