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Member Advisory
FDA Extends Deadline for Public Comments on Draft Guidelines for CAM Products
Date: April 27, 2007
To: Selected ABC Members and Stakeholders
From: American Botanical Council
(Austin, TX.) The U.S. Food and Drug Administration (FDA) yesterday extended the deadline for public comments on the draft document, Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration. 1 http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf
The new deadline for filing public comments is May 29, 2007.
On February 27, 2007 the FDA issued this as a proposed set of guidelines in the Federal Register (FR) which the agency attempted to clarify its role in regulating so-called “CAM products”. The document stated that the public would have 90 days from the date of publication to comment. However, the agency apparently erred in stating that the deadline would be April 30, instead of 90 days from February 27, which should be May 29. This error was discovered by the vigilance of the American Herbal Products Association, the leading trade association dealing exclusively with herbs and herbal products, and was communicated to FDA in a letter. (Presumably this is the reason for the agency’s extension of the deadline. The actual date on the document is “December 2006”, the time the document was completed, even though it was not published in the FR until February.)
The FDA’s publication of the proposed new guidelines has generated a significant level of e-mails and Internet discussion among members of the Complementary and Alternative Medicine (CAM) community, health freedom activists, members of the herb and dietary supplement industry, and others. During the past weeks ABC has received numerous requests from ABC members for requests for clarification. Many e-mails and communications among the lay public have questioned whether the FDA may be reaching out for new regulatory territory – whether the agency may be attempting to regulate new domains of activity, i.e., the practice of CAM as opposed to the agency’s traditionally regulated areas, i.e., foods, drugs, biologics, cosmetics and medical devices.
There has also been confusion about whether FDA is proposing new rules governing the use of herbs, dietary supplements, or other materials in the practice of CAM. Some people appear to be unaware that FDA does not create “legislation” – that is the domain of Congress and state legislatures. Others have referred to the guidance document “proposed new regulations.” Regulations are prepared by government agencies to interpret and enforce legislation, which this is not. However, guidance documents do not have the effect of a regulation; at best they reflect the agency’s current thinking at the time they are written but they not have the enforcement authority of regulations. They are advisory and can be seen as recommendations. FDA also does not regulate the practice of medicine, whether it is conventional or CAM. Such function is the domain of various state licensing boards.
Some observers initially saw this document as merely a clarification of FDA’s existing authority to regulate items used for the diagnosis, cure, prevention or treatment of disease, whether in a CAM or conventional practice. Others, however, are concerned about what they consider may be FDA’s too-broad reach in this area.
Numerous consumer, professional and industry groups are reportedly filing public comments with the FDA, with some groups having done so already in order to meet the previous April 30 deadline. ABC has been in contact with numerous attorneys and other regulatory experts to investigate this issue and is contemplating filing public comments, probably by the extended May 29 deadline.
A cogent assessment of this situation, including interviews with numerous CAM community leaders, can be accessed on John Weeks Integrator Blog. 2 http://theintegratorblog.com/site/index.php?option=com_content&task=view&id=274&Itemid=189
For an interview with the FDA official who co-authored the draft guidance, see also Weeks’ Integrator Blog. 3 http://theintegratorblog.com/site/index.php?option=com_content&task=view&id=276&Itemid=189
References
1. Food and Drug Administration. Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration. Federal Register. Feb. 27, 2007. Docket 2006D-0480. Available at: <http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf>.
2. Weeks J. Integrator Special Report: The FDA's Guidance on CAM - What is the Appropriate Response? The Integrator Blog. April 18, 2007. Available at: <http://theintegratorblog.com/site/index.php?option=com_content&task=view&id=274&Itemid=189>.
3. The FDA's CAM Guidance: Interview with the FDA's Co-Author and Senior Scientific Adviser Philip Chao. The Integrator Blog. April 20, 2007. Available at: <http://theintegratorblog.com/site/index.php?option=com_content&task=view&id=276&Itemid=189>.
Member Advisory
FDA Extends Deadline for Public Comments on Draft Guidelines for CAM Products
Date: April 27, 2007
To: Selected ABC Members and Stakeholders
From: American Botanical Council
(Austin, TX.) The U.S. Food and Drug Administration (FDA) yesterday extended the deadline for public comments on the draft document, Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration. 1 http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf
The new deadline for filing public comments is May 29, 2007.
On February 27, 2007 the FDA issued this as a proposed set of guidelines in the Federal Register (FR) which the agency attempted to clarify its role in regulating so-called “CAM products”. The document stated that the public would have 90 days from the date of publication to comment. However, the agency apparently erred in stating that the deadline would be April 30, instead of 90 days from February 27, which should be May 29. This error was discovered by the vigilance of the American Herbal Products Association, the leading trade association dealing exclusively with herbs and herbal products, and was communicated to FDA in a letter. (Presumably this is the reason for the agency’s extension of the deadline. The actual date on the document is “December 2006”, the time the document was completed, even though it was not published in the FR until February.)
The FDA’s publication of the proposed new guidelines has generated a significant level of e-mails and Internet discussion among members of the Complementary and Alternative Medicine (CAM) community, health freedom activists, members of the herb and dietary supplement industry, and others. During the past weeks ABC has received numerous requests from ABC members for requests for clarification. Many e-mails and communications among the lay public have questioned whether the FDA may be reaching out for new regulatory territory – whether the agency may be attempting to regulate new domains of activity, i.e., the practice of CAM as opposed to the agency’s traditionally regulated areas, i.e., foods, drugs, biologics, cosmetics and medical devices.
There has also been confusion about whether FDA is proposing new rules governing the use of herbs, dietary supplements, or other materials in the practice of CAM. Some people appear to be unaware that FDA does not create “legislation” – that is the domain of Congress and state legislatures. Others have referred to the guidance document “proposed new regulations.” Regulations are prepared by government agencies to interpret and enforce legislation, which this is not. However, guidance documents do not have the effect of a regulation; at best they reflect the agency’s current thinking at the time they are written but they not have the enforcement authority of regulations. They are advisory and can be seen as recommendations. FDA also does not regulate the practice of medicine, whether it is conventional or CAM. Such function is the domain of various state licensing boards.
Some observers initially saw this document as merely a clarification of FDA’s existing authority to regulate items used for the diagnosis, cure, prevention or treatment of disease, whether in a CAM or conventional practice. Others, however, are concerned about what they consider may be FDA’s too-broad reach in this area.
Numerous consumer, professional and industry groups are reportedly filing public comments with the FDA, with some groups having done so already in order to meet the previous April 30 deadline. ABC has been in contact with numerous attorneys and other regulatory experts to investigate this issue and is contemplating filing public comments, probably by the extended May 29 deadline.
A cogent assessment of this situation, including interviews with numerous CAM community leaders, can be accessed on John Weeks Integrator Blog. 2 http://theintegratorblog.com/site/index.php?option=com_content&task=view&id=274&Itemid=189
For an interview with the FDA official who co-authored the draft guidance, see also Weeks’ Integrator Blog. 3 http://theintegratorblog.com/site/index.php?option=com_content&task=view&id=276&Itemid=189
References
1. Food and Drug Administration. Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration. Federal Register. Feb. 27, 2007. Docket 2006D-0480. Available at: <http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0480-gld0001.pdf>.
2. Weeks J. Integrator Special Report: The FDA's Guidance on CAM - What is the Appropriate Response? The Integrator Blog. April 18, 2007. Available at: <http://theintegratorblog.com/site/index.php?option=com_content&task=view&id=274&Itemid=189>.
3. The FDA's CAM Guidance: Interview with the FDA's Co-Author and Senior Scientific Adviser Philip Chao. The Integrator Blog. April 20, 2007. Available at: <http://theintegratorblog.com/site/index.php?option=com_content&task=view&id=276&Itemid=189>.
