02.06.18
The American Herbal Products Association (AHPA) submitted nearly 100 pages of comments to the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) identifying numerous ways to improve regulations, guidance documents, and enforcement practices to protect public health more effectively and efficiently.
AHPA's comments addressed a wide range of regulatory issues impacting food and supplement companies and were submitted in response to FDA's Sept. 8, 2017 request for help identifying existing regulations and paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reductions while allowing FDA to achieve its public health mission and fulfill statutory obligations. FDA's September notice was in response to the Trump Administration's Executive Order 13771 (EO 13771), "Reducing Regulation and Controlling Regulatory Cost," and Executive Order 13777 (EO 13777), "Enforcing the Regulatory Reform Agenda."
"Current dietary supplement regulations have been overwhelmingly successful in ensuring consumer access to high-quality, safe products, but there are several opportunities to improve these requirements to reduce burdens while maintaining consumer protections," said AHPA President Michael McGuffin. "AHPA's extensive recommendations seek to reduce unnecessary regulatory burdens, improve the clarity of industry requirements and provide consumers with more comprehensive and accurate information."
AHPA's recommendations seek to improve regulatory requirements in several areas, including:
The comments also recommended several changes to help the industry better understand and comply with cGMP requirements, including requiring FDA facility inspectors to cite the underlying cGMP regulations when making observations listed in Form 483s issued to facilities after an inspection. AHPA also provided recommended definitions to clarify the terms "manufacturing," "packaging," "labeling," "holding," "identity," "purity," "strength," and "composition" used in the regulations. AHPA encouraged FDA to allow properly completed batch records to be acknowledged as adequate to confirm specifications in the absence of existing analytical methods because it is very rare for valid test methods to currently exist and be generally available for chemically complex food ingredients, such as botanicals.
AHPA requested several changes to improve consumer information on dietary supplement product labels, including allowing companies to reference scientifically accurate information in published literature even when it discusses the diagnosis, treatment, cure, or prevention of a disease, so long as the supplement itself is not making drug claims. AHPA also encouraged FDA to revise its policy of restricting implied disease claims because it has stifled the ability of marketers to make true statements describing "the role of a nutrient or dietary ingredient intended to affect the structure or function in humans," characterizing "the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function," or describing "general well-being from consumption of a nutrient or dietary ingredient" as permitted by the Dietary Supplement, Health and Education Act (DSHEA).
AHPA also encouraged FDA to work with the Environmental Protection Agency (EPA) to revise pesticide regulations and enforcement in a manner that maintains protections for consumers and the environment while also reducing burdens on food companies that use specialty or minor crops such as herbs and spices.
AHPA recommended that FDA immediately withdraw or significantly revise the current NDI guidance document because it is not consistent with the statute and is misleading to the regulated industry. AHPA also urged FDA to discontinue its recent practice of redacting almost all the information in submitted NDI notifications in order to provide real-world guidance for future submitters.
AHPA's comments addressed a wide range of regulatory issues impacting food and supplement companies and were submitted in response to FDA's Sept. 8, 2017 request for help identifying existing regulations and paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reductions while allowing FDA to achieve its public health mission and fulfill statutory obligations. FDA's September notice was in response to the Trump Administration's Executive Order 13771 (EO 13771), "Reducing Regulation and Controlling Regulatory Cost," and Executive Order 13777 (EO 13777), "Enforcing the Regulatory Reform Agenda."
"Current dietary supplement regulations have been overwhelmingly successful in ensuring consumer access to high-quality, safe products, but there are several opportunities to improve these requirements to reduce burdens while maintaining consumer protections," said AHPA President Michael McGuffin. "AHPA's extensive recommendations seek to reduce unnecessary regulatory burdens, improve the clarity of industry requirements and provide consumers with more comprehensive and accurate information."
AHPA's recommendations seek to improve regulatory requirements in several areas, including:
- Regulations for conventional food and dietary supplement operations and farms
- Dietary supplement manufacturing requirements
- The Produce Safety rule under the Food Safety Modernization Act (FSMA)
- Labeling requirements for foods and dietary supplements
- Pesticide regulations
- New dietary ingredients (NDIs)
The comments also recommended several changes to help the industry better understand and comply with cGMP requirements, including requiring FDA facility inspectors to cite the underlying cGMP regulations when making observations listed in Form 483s issued to facilities after an inspection. AHPA also provided recommended definitions to clarify the terms "manufacturing," "packaging," "labeling," "holding," "identity," "purity," "strength," and "composition" used in the regulations. AHPA encouraged FDA to allow properly completed batch records to be acknowledged as adequate to confirm specifications in the absence of existing analytical methods because it is very rare for valid test methods to currently exist and be generally available for chemically complex food ingredients, such as botanicals.
AHPA requested several changes to improve consumer information on dietary supplement product labels, including allowing companies to reference scientifically accurate information in published literature even when it discusses the diagnosis, treatment, cure, or prevention of a disease, so long as the supplement itself is not making drug claims. AHPA also encouraged FDA to revise its policy of restricting implied disease claims because it has stifled the ability of marketers to make true statements describing "the role of a nutrient or dietary ingredient intended to affect the structure or function in humans," characterizing "the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function," or describing "general well-being from consumption of a nutrient or dietary ingredient" as permitted by the Dietary Supplement, Health and Education Act (DSHEA).
AHPA also encouraged FDA to work with the Environmental Protection Agency (EPA) to revise pesticide regulations and enforcement in a manner that maintains protections for consumers and the environment while also reducing burdens on food companies that use specialty or minor crops such as herbs and spices.
AHPA recommended that FDA immediately withdraw or significantly revise the current NDI guidance document because it is not consistent with the statute and is misleading to the regulated industry. AHPA also urged FDA to discontinue its recent practice of redacting almost all the information in submitted NDI notifications in order to provide real-world guidance for future submitters.
