Homeopathic Certifications & Compliances

Given the importance that natural shoppers and natural product retailers place on certifications that ensure pure ingredients, ethically produced products, and protection of the environment, investing in key certifications may be good business practice. In fact, consumer demand has influenced some claims that have been historically applicable for foods to now be a factor for drugs (e.g., non-GMO and gluten-free claims).

However implementing some of these certifications may take years, and yet demand for trending certifications that seem crucial today could fade quickly in the future. With that in mind, AAHP provides a list of requirements, along with a list of options to think about and potentially work toward.

Domestic and International Regulatory Requirements

1. U.S. Food and Drug Administration (FDA) Compliance – FDA is the principle regulator of manufacturing and labeling of homeopathic drug products in the United States: See 21 CFR 210 & 211 and 21 CFR 201 for labeling. Although FDA inspects manufacturing facilities for regulatory compliance, the Agency does not certify facilities as GMP-compliant. For commercial purposes, firms may find it necessary to seek external certification in addition to FDA inspections. Commonly recognized auditors are NSF, UL, BRC, and Veritas for this critical quality assurance standard.

All domestic organizations involved in the manufacture, preparation, propagation, compounding, or processing of homeopathic drugs must register with FDA as a drug establishment and list their homeopathic drug products (see 21 CFR 207). This registration ensures that FDA is aware of manufacturers and labelers of drug products destined for the U.S. market. FDA regulations require annual re-certification of all drug lists and site registrations — both foreign and domestic. The accuracy of your listing and registrations can and should be double-checked and can be found at the FDA National Drug Code Directory.

2. Homeopathic Pharmacopoeia of the United States (HPUS) Compliance – HPUS is the official compendium of homeopathic medicines recognized by FDA; compliance is required for homeopathic products in the U.S. To be recognized as a homeopathic medicine, a product must conform to the standards and monographs outlined in the HPUS, which focus on safety, quality, and standardization. HPUS does not certify products to be compliant. Compliance with HPUS specifications is based on self-certification. Readers are advised to have an active subscription to the HPUS, have thorough knowledge of it, and apply its requirements to the manufacturing of their products. Compliance with HPUS specifications will likely be a topic during FDA inspections.
3. International Requirements – United States law requires that drug products shipped internationally comply with regulatory requirements of the destination country. Internationally recognized GMP standards for homeopathic product manufacturers who export globally include, among others, the requirements of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which are adopted by FDA and, where applicable, pharmaceutical quality standards of the World Health Organization (WHO).
4. ISO 9001: Quality Management System Standard – Verifies that manufacturers follow consistent quality control measures in general. ISO certification may be a requirement of certain customers or jurisdictions around the world.

Environmental & Sustainability Certifications & Compliances

1. ISO 14001: Environmental Management System Standard – Helps manufacturers such as homeopathic companies reduce their environmental impact through sustainable operations. Demonstrates commitment to minimizing waste and optimizing energy use in production facilities.
2. Carbon Neutral Certification – Demonstrates a company’s commitment to offsetting its carbon footprint by reducing emissions in its supply chain and manufacturing processes. Can often be done using a third-party organization.
3. Ecocert Certification – Helps companies with certification for 150+ standards, some of which are listed throughout this article. This is an international service.

Packaging and Material Certifications & Compliances

1. Sustainable Forestry Initiative (SFI) Certification – Ensures that packaging materials (such as paper boxes for homeopathic products) come from responsibly managed forests.
2. Forest Stewardship Council (FSC) Certification – Guarantees that paper-based packaging materials are sustainably sourced. Similar to SFI, it is a chain-of-custody certification.
3. How2Recycle – Communicates recycling instructions to consumers through a clear and standardized labeling system. Helps manufacturers meet consumer expectations and local recycling guidelines while improving packaging circularity.
4. Extended Producer Responsibility (EPR) Compliance – Requires manufacturers to take responsibility for the lifecycle of their product packaging, including disposal and recycling. Several U.S. states (California, Oregon, Maine, Colorado, and Minnesota) have enacted EPR regulations mandating that packaging be recyclable, compostable, or minimized.
5. FTC Green Guides Compliance – Ensures that environmental marketing claims about homeopathic products and packaging are truthful, substantiated, and not misleading. Prohibits vague claims like "eco-friendly" or "green" without specific, verifiable evidence.

“Health Food”-Type Certifications & Compliances

1. United States Department of Agriculture (USDA) Organic Certification – Allows a processing facility to sell, label, and represent their products as organic, meaning ingredients are produced without synthetic pesticides, herbicides, or GMOs.
2. Non-GMO Project Verified – Guarantees foods do not contain genetically modified organisms. The group has expanded to verify other orally-consumed products, such as homeopathic medicines.
3. Gluten-free Labeling for Food (21 CFR 101.91) – Provides FDA recommendations for labeling food as free of gluten, but is a good guide for homeopathic medicines since the Agency does not provide regulations for labeling drugs as gluten-free. Gluten-free is a self-certification program requiring test results demonstrating that a product contains less than 20 parts per million (ppm) gluten.

Ethical and Social Responsibility Certifications & Compliances

1. Fairtrade Mark – Assures integrity, traceability in supply chains, or products/ ingredients responsibly sourced — which means buying key commodities fairly and sustainably as a core part of how a company does business. It is an independent and international certification.
2. Leaping Bunny – Helps make shopping for animal-friendly products easier and more trustworthy with an internationally recognized logo. It is managed by the Coalition for Consumer Information on Cosmetics (CCIC) — a group of eight national animal protection groups that banded together in 1996 to create a single comprehensive standard.
3. B Corp Certification – Recognizes companies that meet high social, environmental, and transparency standards, including sustainable sourcing and ethical production.
4. ISO 20400: Sustainable Procurement Guidance – Provides guidance for organizations to integrate sustainability into their procurement processes, considering environmental, social, and economic impacts. Useful to fulfill the requirement of at least one mass marketer’s private label brands requirement for an ethical sourcing annual audit (e.g., social responsibility in who a manufacturer hires, how they are treated, and how their safety is protected, etc.).