| Comment Record|
Mr. Anthony L. Young ||
2002-08-30 15:58:14 |
Piper Rudnick |
| Comments for FDA General |
1. General Comments
Docket No. 02N-0275
THE UNITED STATES OF AMERICA
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
INITIAL COMMENTS OF THE
AMERICAN HERBAL PRODUCTS ASSOCIATION
ON THE IMPLEMENTATION OF REGULATIONS FOR
AS REQUIRED BY
Public Health Security and Bioterrorism Preparedness and Response Act of 2002
August 30, 2002
The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal products industry, comprised of companies doing business as growers, processors, manufacturers, and marketers of herbs and herbal products. AHPA serves its members by promoting the responsible commerce of products that contain herbs.
The United States Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“the Bioterrorism Act” or “the Act”) to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies, and President Bush signed this legislation into law on June 12, 2002. The Act consists of five separate titles. AHPA and its members have significant interest in certain of the statutory requirements established in Title III of the Act (Protecting Safety and Security of Food and Drug Supply) and their implementation.
Joseph Levitt, Director, Center for Food Safety and Applied Nutrition, addressed a letter to the FDA Foods Community dated July 17, 2002. This letter provided, among other things, an overview of those provisions of Title III of the Act that require the Food and Drug Administration (FDA) to issue regulations in an expedited time period. The July 17 letter also solicited comments to identify concerns and to provide recommended solutions and supporting data, if applicable, and requested that initial comments be delivered by August 30, 2002. This request was repeated at a meeting at FDA’s College Park, MD offices on July 30, 2002.
Subject of these comments
The Comments provided here are in response to these requests, and specifically in relation to concerns and recommendations that AHPA has identified with regard to Section 303 of the Act, which authorized, effective immediately upon the enactment of the Act, the detention, on terms defined in the section, of any article of food for which a qualified agent of FDA has credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals. This section also requires that regulations for instituting expedited detentions of perishable foods be promulgated, but does not set forth a specific timeframe for completion of such rulemaking.
Possible impact on AHPA members
Subtitle A of Title III of the Act contains those sections of the Act that are related to protection of the food supply in order to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies. It is, of course, impossible to speculate on whether a person who would intentionally adulterate a food would choose as their target an herbal dietary supplement, usually consumed in small servings and in a dried form as a tablet or capsule and by a relatively small population, or whether there is a higher likelihood that a more broadly consumed common food with a larger serving size and that is in a form that might be a more viable vector would be identified as a better target. Thus, all AHPA members and all of their products are potentially affected by the administrative detention defined in Section 303.
In addition, while the majority of herbal food products are manufactured using dehydrated plant materials, AHPA’s members include persons that manufacturer products that have as ingredients botanicals that are in a non-dehydrated state and so are perishable. Thus, procedures that are provided in the implementing regulations for instituting administrative detention on an expedited basis with respect to perishable foods could have an effect on these companies.
Comments and recommendations
There is a possibility that the expanded authority for administrative detention defined in this section of the Act could be interpreted more broadly than the Congressional intent in providing this authority. In order to protect against such possibility, rulemaking should define, as nearly as possible without diminishing the usefulness of this authority in protecting the public health by preventing, preparing for and responding to bioterrorism, the level of evidence or information necessary to rise to the level of “credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death in humans or animals.”
With regard to herbal ingredients that are perishable, there is some range in the time and conditions that can effect whether they have been held beyond their useful life. Some ingredients may be unusable within a very short time, such as a day or less, while others might still be usable after being detained for several days. The conditions in which goods are held, however, will often have a significant influence on the time in which such ingredients can still be utilized. For example, refrigeration or hydration with occasional spraying with water can greatly extend the time in which some ingredients can be maintained in usable condition. AHPA therefore recommends that the procedures regarding administrative detention under this section for perishable foods include some process under which the owners of such foods are allowed to take steps necessary for the preservation of such foods until the detention is resolved.
AHPA appreciates the opportunity to provide these initial comments prior to FDA’s issuance of an advance notice of proposed rulemaking in the matter of administrative detention, and will continue to be attentive to this important process as it unfolds.
President, American Herbal Products Association
8484 Georgia Avenue
Silver Spring, MD 20910
Anthony L. Young
General Counsel, American Herbal Products Association
Piper Rudnick LLP
1200 19th Street, N.W.
Washington, D.C. 20036