01.02.14
The American Herbal Products Association (AHPA), Silver, Spring, MD, submitted nearly 200 pages of comments and suggested revisions to FDA in response to the first two proposed rules issued to implement portions of the FDA Food Safety Modernization Act (FSMA).
The rules that FDA first proposed on Jan. 16, 2013, would create new regulations for human food manufacturers (Current Good Manufacturing Practice (cGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food) and subject certain farming activities to risk-based standards (Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption).
If implemented in the form proposed, the FSMA regulations for produce would impact the botanical products industry because FDA proposed that many of the botanicals used by AHPA members be classified as produce subject to these production standards. The proposed hazard analysis and risk-based preventive controls regulations for human food would not apply to cGMP-compliant dietary supplement manufacturers but would apply to suppliers of dietary ingredients and other component ingredients that are used by dietary supplement manufacturers.
In the comments, AHPA stressed that these proposed rules are the most far-reaching regulations FDA has ever promulgated, and that they will likely impact the entire U.S. food production system. Given the scope and potential impact of the proposed rules, AHPA urged FDA to publish a second set of proposed rules to collect additional comments.
“These proposals would likely increase costs and burdens significantly throughout the food production system. There is a very real risk that small-volume crops and products, as well as small companies, will be pushed entirely out of the marketplace, to the detriment of consumers and producers,” said Staci Eisner, chair of AHPA’s Government Relations committee. “The broad and deep impact of the new, proposed regulations necessitates regulatory restraint. AHPA’s comments suggest ways FDA can streamline and focus the proposed rules to significantly minimize the burdens and costs while also preserving the new protections for food safety.”
AHPA’s comments are aimed at assuring that, once implemented, these rules do not unnecessarily burden AHPA members or their suppliers.
“AHPA’s comments focus on minimizing costs of implementation by reducing redundancies and maximizing regulatory flexibility, and clarifying the specific language of these rules to eliminate as much confusion as possible when the rules are implemented,” said AHPA President Michael McGuffin.
The rules that FDA first proposed on Jan. 16, 2013, would create new regulations for human food manufacturers (Current Good Manufacturing Practice (cGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food) and subject certain farming activities to risk-based standards (Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption).
If implemented in the form proposed, the FSMA regulations for produce would impact the botanical products industry because FDA proposed that many of the botanicals used by AHPA members be classified as produce subject to these production standards. The proposed hazard analysis and risk-based preventive controls regulations for human food would not apply to cGMP-compliant dietary supplement manufacturers but would apply to suppliers of dietary ingredients and other component ingredients that are used by dietary supplement manufacturers.
In the comments, AHPA stressed that these proposed rules are the most far-reaching regulations FDA has ever promulgated, and that they will likely impact the entire U.S. food production system. Given the scope and potential impact of the proposed rules, AHPA urged FDA to publish a second set of proposed rules to collect additional comments.
“These proposals would likely increase costs and burdens significantly throughout the food production system. There is a very real risk that small-volume crops and products, as well as small companies, will be pushed entirely out of the marketplace, to the detriment of consumers and producers,” said Staci Eisner, chair of AHPA’s Government Relations committee. “The broad and deep impact of the new, proposed regulations necessitates regulatory restraint. AHPA’s comments suggest ways FDA can streamline and focus the proposed rules to significantly minimize the burdens and costs while also preserving the new protections for food safety.”
AHPA’s comments are aimed at assuring that, once implemented, these rules do not unnecessarily burden AHPA members or their suppliers.
“AHPA’s comments focus on minimizing costs of implementation by reducing redundancies and maximizing regulatory flexibility, and clarifying the specific language of these rules to eliminate as much confusion as possible when the rules are implemented,” said AHPA President Michael McGuffin.
