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Industry Self-Regulation for Dietary Supplements

Certificate of Analysis for Dietary Supplement Components

This document serves as a guideline for the preparation by suppliers and appropriate use by their customers of a Certificate of Analysis (COA) for Dietary Supplement Components.

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FAQs

FAQs About OTC Monograph Reform for Manufacturers
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Background Summary: Pediatric Acetaminophen Dosing

FDA Announcement of a proposed safety-based Administrative Order (AO) to address dosage strengths of oral, single ingredient, pediatric acetaminophen products. This AO proposal includes the addition of weight and age-based dosing for children under age 12.

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Dispensing Authority

Given pharmacists' drug knowledge and public accessibility, states are exploring expanding their scope of practice permanently after the pandemic emergency measures expire. Empowering pharmacists to dispense products like oral contraceptives, and other consumer healthcare products could improve access and outcomes.

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Dietary Supplement Resource Library

Explore our list of resources to learn more about the dietary supplement category and how it is regulated by the U.S. Food and Drug Administration and Federal Trade Commission.

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Insurance Coverage

Providing coverage for clinically-validated, over-the-counter products capable of preventing complications or replacing higher cost prescriptions through flexible spending arrangements aligns with value-based models working to improve access and outcomes across populations.

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Informed Consumer Decision Making

Voluntary Labeling Program for Dietary Supplements Proposed Pregnancy/Nursing Label Statement

Members of CHPA which market dietary supplements formally initiated a voluntary labeling program on March 22, 2000 which relates to the use of the following label statement on dietary supplement products.

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Labeling OTC Medications in the States

Having individual states impose distinct labeling rules would create confusion around critical health details printed on packaging.

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Informed Consumer Decision Making

Voluntary Labeling Program for Dietary Supplements Proposed St. John's Wort Information Statement

Members of the Consumer Healthcare Products Association who market dietary supplements containing St. John's wort initiated a voluntary labeling program on April 2, 2000.

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Guideline for the Stability Testing of Nonprescription (OTC) Drug Products Not Regulated by an NDA/ANDA

The objective of this guideline is to define the minimum stability data package to support the commercial distribution of OTC monograph drug products in the United States per climatic zone.

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