The National Homeopathic Product Certification Board provides an avenue for self-regulation by the homeopathy community of homeopathic medicines. It is designed to help consumers and practitioners identify homeopathic products that have been verified as being manufactured and labeled according to standards set out by the AIH, the Homeopathic Pharmacopoeia of the United States (HPUS), and the U.S. Food and Drug Administration (FDA).

The National Homeopathic Product Certification Board has no affiliation with the U.S. Food and Drug Administration, nor is it endorsed by the agency. However, NHPCB leadership and staff consult with a wide range of stakeholders including the FDA to provide information and updates to them and to receive feedback on NHPCB’s efforts.

Consumers and practitioners currently have no third-party-verified way to tell whether a product claiming to be homeopathic actually meets HPUS and FDA standards.

In today’s marketplace there are various products labeled “homeopathic” but which:

1. Do not comply with HPUS standards; and/or
2. Fail to meet Current Good Manufacturing Practice (CGMP) standards; and/or
3. Are manufactured in facilities that are not registered with the FDA. Those in this category are operating illegally under federal law. Companies that manufacture in or import drugs into the United States, including homeopathic drugs, must register with the FDA and allow FDA inspections of their facilities.

In addition, the FDA’s current recently adopted Guidance on products labeled as homeopathic makes no distinction for enforcement purposes between homeopathic medicines that meet the previously mentioned standards and therefore pose no reasonable risk and those that do not and therefore may pose a risk to the public. The Seal will provide some assurance to the FDA that a homeopathic product bearing the Seal has been manufactured and labeled in accordance with recognized standards.

The NHPCB was initiated in 2020 by a group of members of the American Institute of Homeopathy. This core group then recruited other volunteers to provide legal, organizational, technical, regulatory and marketing expertise. More than 20 volunteers have contributed to the project.

1. We have made significant efforts to reach out to manufacturers and brand owners to inform them about the National Homeopathic Product Certification Board. The responses have been almost entirely positive and appreciative. Many believe that self-regulation originating from within the homeopathic community is not only long overdue, but a sign that the community is maturing (since many other industries also submit to third-party verification as a means of ensuring quality).

Members of the Steering Committee met with a group of representatives from the FDA in a “listening session” to convey the goals and essential details of the Seal Project. The two groups agreed to establish an ongoing line of communication to provide updates on the Project. The FDA asked to see the Seal standards once they have been made publicly available.

The Seal will provide a reliable way for consumers and practitioners to identify homeopathic products verified to meet recognized standards. As the number of products verified grows, consumers and practitioners will have an ever wider array of choices that they know meet recognized standards.

First and foremost, manufacturers and brand owners will have a way to address FDA concerns about the safety of the homeopathic products they make and sell. Self-regulation of homeopathy is designed to lead to better relations with the FDA and to refocus the agency’s enforcement efforts on products that do NOT meet recognized standards.

Second, products bearing the seal will over time become recognized by consumers and practitioners as genuine, safe homeopathic products that deserve their loyalty. We believe that this will translate into greater sales for participating companies.

Brand Owner and Manufacturer registration will provide a reliable way for consumers and practitioners to identify homeopathic companies that meet recognized standards. Lastly reseller registration provides a method for consumers to locate Certified Homeopathic Seal products within their community.

Homeopathy in the United States is at the mercy of the FDA and its policy decisions. The withdrawal of the FDA’s previous guidance, Compliance Policy Guide 400.400, has led to confusion and chaos in the homeopathy community. The recent adoption of the agency’s new guidance will only prolong the confusion and chaos.

The Seal is part of a larger effort to steer FDA policy and enforcement decisions down a road that will be more sustainable for homeopathy, one that safeguards access to the full range of homeopathic medicines while ensuring consumer safety.

By demonstrating that the homeopathic drug industry can responsibly self-regulate, the Seal Project will enhance the credibility of the homeopathy community and thus its ability to influence FDA policy and enforcement policies. It will also aid efforts to seek a legislative solution to the current chaos by showing the U.S. Congress that the homeopathy community is united and competent. It is a community which can be trusted to provide sensible solutions that protect both access and health.

Some of the funds raised by the Seal project will be reinvested into public education through its website and outreach programs for the purpose of growing the community of informed consumers and connecting them with practitioners.

Finally, the Seal provides a convenient way for researchers to identify homeopathic medicines suitable for use in clinical trials and other studies.

The NHPCB is a 501(c)(3) charitable organization.  The organization is guided by a Board of Directors who are elected by the AIH Board of Directors.   A Steering Committee oversees day to day operations and is made up of its director, committee leaders and other experts. The Steering Committee provides recommendations regarding standards and practices to the NHPCB board for review, adoption and implementation by NHPCB staff and qualified consultants.

The AIH is the oldest continuous national medical society in the United States.  The NHPCB is designed to increase public knowledge and acceptance of homeopathy. This is completely aligned with the educational goals of the AIH.

As an organization with homeopathic medical expertise that is free of industry influence, the AIH is uniquely qualified to be the standard-bearer for the Seal.

The AIH name will lend credibility to the Seal. The AIH imprimatur will assure the public and regulators that the governing body of the certification process, the NHPCB, will be free of conflicts of interest since it will be overseen by licensed medical practitioners not associated with the industry.

To date the NHPCB has been funded by contributions from many generous homeopathic foundations, homeopathic societies and individual donors.  Ultimately, however, the NHPCB is expected to be financially self-sustaining through fees generated by applications and renewal process.

Brand Owners and Manufacturers fill out registration applications to apply for annual registration. In the registration process, the Brand Owner submits a listing of their homeopathic products. The NHPCB then determines which homeopathic products require product applications, using a risk based approach. Companies are required to submit 10% of their products for application if they carry less than 250 products, and 5% of their products for application if they carry 250 products or more. Certification of products is for three years.

Review committees examine applications for completeness and accuracy and then determine whether companies and products named in various applications meet the standards. Generally, the review committees will work with applicants to make sure their applications have all the necessary information before evaluating applications. In the event that an application is denied, applicants will be encouraged to correct any problems that led to the denial and resubmit. Applicants may also appeal a denial as explained in the Application Handbook.

Four independent pathways to obtain the right to use the seal have been identified. Two of these pathways have been defined and will be available to applicants in Fall, 2023:

Standards for Single Ingredients/Single Potency Currently Listed in the Homeopathic Pharmacopoeia of the United States.

Standards for Combination Formulations with All Active Ingredients Currently Listed in the Homeopathic Pharmacopoeia of the United States.

The National Homeopathic Adverse Event Reporting Database is an important part of the NHPCB process.  Brand owners will be submitting data on adverse events for all of their homeopathic products.  This data will be entered into the National Homeopathic Adverse Event Reporting Database and used to verify safety of homeopathic ingredients and formulations to regulatory authorities.  In addition this data will be used to support scientific research related to the safety of homeopathic medicines.  Similar Adverse Event Reporting Databases have proven quite useful in other segments of the healthcare industry.