AHPA Guidance Documents

AHPA produces these guidance documents on specific topics to help the industry comply with applicable laws and regulations and institute best practices that help ensure quality and transparency.

 

The following Guidance Documents are accessible to AHPA members only.

Additional guidance is available in AHPA's Guidance Policies.

 

Botanical Ingredients

Revised May 2021 | Download

This document provides guidance to growers, collectors, and processors of botanical crops. Its goals are to ensure that the herbal raw materials used in consumer products are accurately identified, are not adulterated with contaminants that may present a public health risk, and are in full conformity with all of the quality characteristics for which they are represented.

Related: GACP-GMP Individual Assessment Tools

October 2017 | Download

This document provides guidance on maximum quantitative limits of foreign matter in herbal raw materials. It is natural for herbal raw materials to contain some foreign matter. Official pharmacopeias worldwide recognize quantitative limits of foreign matter as part of monograph specifications for herbal raw materials. Limits of foreign matter for the same herbal material may differ in various pharmacopeias.

March 2013 | Download

The document provides practical aid and general guidance for companies implementing organoleptic characterization, with or without macroscopic descriptors, for the identification of botanical materials though it may also have application to the identification of other dietary components.

Revised November 2021 | Download

The Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) is an international agreement that became effective in 1975 and currently includes 182 countries and the European Union as members. Specific requirements have been established for international trade in plant and animal species that are listed under CITES, and these requirements differ for each of three defined CITES Appendices. The placement of a species in one of the CITES Appendices is determined from the perceived level of potential extinction or endangerment, and exploitation of the species in international trade. The purpose of this document is provide understanding of the processes and practices that must be followed to be in compliance with CITES requirements when importing and exporting CITES-listed species.

 

Botanical Extracts

2001 | Download

This document is intended to improve the industry’s understanding of the terminology, materials, and processes used in the manufacture of botanical extracts, and to reduce the confusion that exists in the marketplace about extracts and their purchase. This document is intended as a guidance and educational document only. It sets forth the goals toward which industry members should strive in order to achieve quality, consistency, safety, and efficacy in their products.

2000 | Download

This document provides guidance for the retail labeling of dietary supplements containing soft or powdered botanical extracts. These guidelines are intended to support responsible trade in herbal products and be in the best interest of consumers.

2001 | Download

This paper is a discussion of marker compounds. It defines them, their common use, their value, and their limitations. Their relationship to active compounds is also considered. This document should serve as an educational piece that stimulates further conversation on the topic of marker compounds. It was developed by industry specialists and reviewed by outside experts with the intent to clarify an evolving aspect of the botanical marketplace.

2003 | Download

There has been a trend in the marketplace toward the use of “standardized” herbal preparations; and in most cases, the word “standardized” is associated with a quantitative claim for the content of a particular constituent or constituents. This document is intended to foster a heightened awareness of the complexities associated with standardization, and to facilitate informed discussions between raw material suppliers, product manufacturers, practitioners, clinicians, regulators, and consumers.

August 2022 | Download

This guidance provides a menu of options with illustrative examples of different approaches to presenting liquid extract product information in various contexts, including Supplement Facts boxes, master formulas, and product specifications. The examples include narrative content that explains the alignment of the elements and their relationship to the product specifications. The examples provided are intended to function as customizable templates.

 

New Dietary Ingredients

Revised September 2011 | Download

This document provides guidance to assist companies in the dietary supplement trade, including ingredient suppliers and consumer product marketers, to facilitate filing a notification with the U.S. Food & Drug Administration (FDA) in advance of marketing a dietary supplement ingredient that meets the definition of a “new dietary ingredient” (NDI) when such notification is required.

 

Manufacturing Operations (cGMP, etc.)

July 2007 | Download

This document presents, in an easily-readable format, the final rule and the interim final rule published by the U.S. Food & Drug Administration (FDA) on June 25, 2007 to codify, in 21 CFR 111, the Current Good Manufacturing Practice In Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. In addition, this document provides annotations to present key points and comments made by FDA in the preambles to those rules.

Revised October 2009 | Download

This document has been prepared to assist in the understanding their rights and obligations when the U.S. Food & Drug Administration (FDA) conducts an inspection of a facility in which food ingredients or dietary supplements are manufactured, processed, packed or held. It provides descriptions and analyses of the current federal laws that are relevant to inspection of food ingredient and dietary supplement facilities and suggestions of how to prepare for and conduct inspections in a manner that fully complies with these laws.

April 2010 | Download

This document explains the principles of good documentation practices, provides step-by-step instructions for many documentation-related processes, and provides numerous examples and templates which can be easily modified for your company’s use. The guidance focuses on documentation systems in the context of manufacturing, packing, or holding dietary supplements, although the principles and many of the procedures and forms overlap with documentation practices used in drug companies and ISO-registered companies, and are also relevant to food and food ingredient facilities.

March 2017 | Download

This document provides health care practitioners who prepare herbal formulas with a published reference that defines a standard of practice in herbal compounding and dispensing undertaken following one-on-one consultations with individuals. This document identifies herbal compounding and dispensing practices that pertain specifically to compounded herbal formulas. Individual establishments may provide differing levels of herbal compounding services and consequently only the relevant parts of this document apply to any given health care practice or establishment.

December 2009 | Download

This document provides guidance on maximum quantitative limits for a group of elements that can be toxic when consumed by humans -- including lead (Pb), mercury (Hg), cadmium (Cd), arsenic (As), and chromium (Cr). The document also discusses relevant regulations about the presence of these chemicals in products sold in the U.S., and daily limits that have been set for these by regulatory agencies and standards-setting organizations, both within the U.S. and elsewhere. In addition, the document reviews available analytical methods for measuring heavy metals, and provides guidance on how to determine which analytical methods are most suitable for dietary supplements and on how to choose a contract lab that can properly conduct heavy metal testing.

September 2017 | Download

Dietary supplement operations are required to comply with title 21 of the Code of Federal Regulations Part 111 (Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements) specifically to confirm the identity of non-dietary components used in their products and determine whether other applicable components’ specifications are met. To fulfill these requirements, manufacturers need to conduct appropriate tests or examinations; or rely on certificates of analysis from suppliers of these components provided that the criteria listed in the rule are satisfied. This document describes test methods that can be used to identify ethanol.

 

Contract Manufacturing

November 2014 | Download

The use of contract manufacturers and packagers is common for both conventional foods and dietary supplements. It is important that contractors and their customers clearly describe and agree in advance on which party will be responsible for which regulatory requirements. This document is designed to assist dietary supplement contractors and their customers to achieve this essential clarity. The checklist addresses operational steps from pre-production to post-market procedures.

November 2014 | Download

The US Federal Food, Drug, and Cosmetic Act (FFDCA), and the regulations implementing it, impose various recordkeeping requirements on firms that manufacture, package, hold, or distribute foods including dietary supplements; this document details those requirements.

November 2014 | Download

The use of contract manufacturers and packagers is common for both conventional foods and dietary supplements. This white paper discusses the procurement of dietary supplements from contractors, starting with initial development of the product and its specifications and paying particular attention to issues which should be negotiated between the parties to avoid problems and confusion.

 

Packaging and Labeling

Revised July 2021 | Download

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) established specific labeling requirements for foods, including dietary supplements, that contain those food ingredients identified under this law to be “major food allergens.” This document presents a summary of FALCPA and identifies those ingredients and preparations found in traditional Chinese herbal ingredients and formulas that may require labeling as major food allergens when included in a product labeled as a food or dietary supplement. It includes the recent revision to FALCPA that recognizes sesame as an additional major food allergen.

Revised June 2021 | Download

This document provides a general summary of the applicable federal labeling requirements to use as a resource when labeling dietary supplement products. AHPA provides this document for informational purposes only, and AHPA intends for its members to use this document as a supplement to, and not a substitute for, the relevant statutes, regulations, and FDA’s published resources (such as its Dietary Supplement Labeling Guide).

July 2011 | Download

This document provides an overview of federal regulations regarding the use of shelf life dates for dietary ingredients and dietary supplements sold in the U.S., with a particular emphasis on botanical ingredients and products. In addition, it presents various strategies for meeting those requirements.

Revised January 2019 | Download

This document provides guidance to assist manufacturers and packagers of food and dietary supplements in complying with federal regulations concerning the slack-fill in food containers.

 

Serious Adverse Event Reporting

February 2013 | Download

This document was prepared to assist companies that receive adverse event reports (AERs) and are responsible for submitting serious adverse event reports (SAERs) under the Dietary Supplement and Nonprescription Drug Consumer Protection Act to obtain complete and accurate information about such reports. The information provided here addresses internal policies that may be established by companies that market such products in preparation for receiving an adverse event report, and also presents ideas for communicating with the reporter of such an event.

 

National Organic Program

January 2018 | Download

This document provides guidance to companies that wish to market organically labeled dietary supplements in the U.S. It includes information about the types of supplements that are eligible for organic certification under the National Organic Program (NOP), and the various NOP labeling categories that are available for several types of supplement products. It also provides an overview of the regulatory obligations that must be met from the farm to the packaged products, as finished product marketers have regulatory obligations not only for their own manufactured products but also for the organic ingredients they use.

 

CA Prop 65

Revised October 2022 | Download

Consumer goods sold in the State of California are, with certain exceptions, subject to California Proposition 65: the Safe Drinking Water and Toxic Enforcement Act of 1986. This document was prepared with a narrow focus: the regulatory and liability implications for cannabis businesses or other entities in the State of California regarding exposure to marijuana smoke, Δ9 THC, and other chemicals listed under Proposition 65. This document does not address the implications of Proposition 65 for hemp products. It is not intended to address any other elements of Proposition 65 except as necessary for the present purpose, nor does it serve as a substitute for this law, its implementing regulations, or legal counsel.

Revised October 2022 | Download

Consumer goods sold in the State of California are, with certain exceptions, subject to California Proposition 65: the Safe Drinking Water and Toxic Enforcement Act of 1986. This document was prepared with a narrow focus: the regulatory and liability implications of Proposition 65 for hemp and hemp-derived products, including cannabidiol (CBD), sold in the State of California. This document does not address the implications of Proposition 65 for marijuana products. It is not intended to address any other elements of Proposition 65 except as necessary for the present purpose, nor does it serve as a substitute for this law, its implementing regulations, or legal counsel.

Revised August 2018 | Download

Consumer goods sold in the State of California are, with certain exceptions, subject to California Proposition 65: the Safe Drinking Water and Toxic Enforcement Act of 1986. This document was prepared with a narrow focus: the regulatory and liability implications of Proposition 65 for constituents that may be present in herbal and other natural products sold in the State of California. It is not intended to address any other elements of Proposition 65 except as necessary for the present purpose, nor does it serve as a substitute for this law, its implementing regulations, or legal counsel.

Revised September 2022 | Download

Consumer goods sold in the State of California are, with certain exceptions, subject to California Proposition 65: the Safe Drinking Water and Toxic Enforcement Act of 1986. This document was prepared with a narrow focus: the regulatory and liability implications of Proposition 65 for tea and infusion products sold in the State of California. It is not intended to address any other elements of Proposition 65 except as necessary for the present purpose, nor does it serve as a substitute for this law, its implementing regulations, or legal counsel.

 

Business Issues

2003 | Download

This document provides guidance to assist manufacturers in understanding and conforming to the federal regulations that govern the drawback of prepaid excise tax on distilled spirits, commonly known as “alcohol,” that is used in the production of nonbeverage products. This guidance is particularly applicable to manufacturers that purchase alcohol manufactured in the U.S. and that produce herbal extracts and tinctures that are sold in liquid form as dietary supplements.

September 2010 | Download

Like all other consumer-goods industries, manufacturers and distributors of dietary supplements purchase products liability insurance in order to protect their businesses and assets against claims associated with their products. The purpose of this document is to provide some basic understanding of products liability insurance and the processes involved in purchasing this insurance by dietary supplement companies. This primer is organized in a question and answer format and addresses numerous issues that are commonly encountered in obtaining products liability insurance.