Homeopathic Certifications & Compliances
Given the importance that natural shoppers and natural product retailers place on certifications that ensure pure ingredients, ethical products, and protection of the environment, investing in key certifications may be good business practice. If 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 to think about and potentially work toward.
Pharmaceutical & Medical Regulation/Quality Certifications & Compliances
1. Good Manufacturing Practices (GMP) Certification
Good Manufacturing Practices (GMP) certification is a critical quality assurance standard for homeopathy manufacturers, ensuring products are consistently produced and controlled according to established quality standards. In the United States, GMP compliance for homeopathic products is overseen by the U.S. Food and Drug Administration (FDA) under Current Good Manufacturing Practice (CGMP) regulations. Commonly recognized auditors are NSF, UL, BRC and Veritas.
2. Homeopathic Pharmacopoeia of the United States (HPUS) Compliance
Required for homeopathic products in the U.S.; HPUS is the official compendium of homeopathic medicines recognized by the FDA. 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.
3. U.S. Food and Drug Administration (FDA) Compliance
Ensures adherence to regulations for drug manufacturing (see 21 CFR 210 & 211) and labeling (see 21 CFR 201), as well as FDA guidance documents. All domestic organizations involved in the manufacture, preparation, propagation, compounding, or processing of homeopathic drugs must register with the FDA as a drug establishment and list their homeopathic drug products (see 21 CFR 207). This registration ensures that the FDA is aware of the organization's activities and can monitor compliance with applicable regulations.
Internationally recognized GMP standards for homeopathic product manufacturers who export globally. Ensures homeopathic medicines meet quality and safety requirements. Recommended for manufacturers exporting to countries that require compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which are adopted by FDA, and when applicable pharmaceutical quality standards of the World Health Organization (WHO).
5. ISO 9001: Quality Management System Standard
Verifies that manufacturers follow consistent quality control measures. Helps maintain uniformity in homeopathic product production.
Environmental & Sustainability Certifications & Compliances
1. ISO 14001: Environmental Management System Standard
Helps homeopathic manufacturers reduce their environmental impact through sustainable operations. Demonstrates commitment to minimizing waste and optimizing energy use in production facilities.
2. United States Department of Agriculture (USDA) BioPreferred Program Certification
It verifies that homeopathic products use biobased (plant-derived) ingredients, reducing reliance on synthetic chemicals.
3. 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.
An international service that helps companies with certification for 150+ standards, some of which are listed throughout this list.
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
Similar to SFI, this certification guarantees that paper-based packaging materials are sustainably sourced. Chain-of-custody certification.
3. How2Recycle
A standardized labeling system that clearly communicates recycling instructions to consumers. It helps manufacturers meet consumer expectations and local recycling guidelines while improving packaging circularity.
4. Extended Producer Responsibility (EPR) Compliance
EPR laws require manufacturers to take responsibility for the lifecycle of their product packaging, including disposal and recycling.
Several U.S. states (e.g., 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.
Organic and Natural Product Certification & Compliances
1. United States Department of Agriculture (USDA) Certified
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.
Guarantees that homeopathic remedies do not contain genetically modified organisms.
3. Gluten-free Labeling
Although FDA does not provide provides regulations for labeling drugs as free of gluten, a good guide is to follow the agency’s recommendations for food labels. (See 21 CFR 101.91).
Ethical and Social Responsibility Certifications & Compliances
An independent and international certification that 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.
Leaping Bunny logo is managed by the Coalition for Consumer Information on Cosmetics (CCIC). This group of eight national animal protection groups banded together in 1996 to create a single comprehensive standard and an internationally recognized logo to help make shopping for animal-friendly products easier and more trustworthy.
Recognizes companies that meet high social, environmental, and transparency standards, including sustainable sourcing and ethical production.
4. ISO standard for ethical and sustainable procurement (ISO 20400:2017)
Provides guidance for organizations to integrate sustainability into their procurement processes, considering environmental, social, and economic impacts. Useful to fulfil 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 hire, how they are treated, and how their safety is protected, etc.)