Navigating the Regulatory Landscape of Probiotics: Understanding the Registration and Approval Process

Regulation of probiotics varies by country, and it is important to understand these regulations to ensure that the probiotic products you are using are safe and effective. In the United States, probiotics are considered dietary supplements and are regulated by the Food and Drug Administration (FDA). Unlike drugs, dietary supplements do not require premarket review or approval by the FDA. However, the FDA has the responsibility to take action against any unsafe dietary supplement product after it reaches the market. Manufacturers are responsible for ensuring that their products are safe and properly labeled before they are sold. This includes ensuring that the product contains the ingredients listed on the label and that the label does not include false or misleading information. The FDA also has the authority to issue warning letters to companies that violate federal laws and regulations related to dietary supplements.

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In addition to federal regulations, some states, such as California, may have additional regulations or oversight in place for probiotic products. For example, in California, probiotic products are regulated by the California Department of Public Health's (CDPH) Food and Drug Branch (FDB). The FDB is responsible for enforcing California's Food and Drug laws and regulations, which include dietary supplements. This means that probiotic products sold in California must comply with both federal and state regulations.

 

Furthermore, California has a unique law called the California Health and Safety Code section 110660, which requires that dietary supplements sold in California be manufactured in compliance with the FDA's Current Good Manufacturing Practices (cGMPs) regulations. This law applies to all dietary supplements, including probiotics, to ensure that they are manufactured under strict guidelines to ensure their safety and efficacy.

 

In the European Union, probiotics are considered food products and are regulated by the European Food Safety Authority (EFSA). The EFSA is responsible for evaluating the safety and efficacy of probiotics before they can be marketed in the EU. To be marketed in the EU, probiotics must be registered with the EFSA and receive a positive opinion from the agency. The registration process includes providing scientific evidence on the safety and efficacy of the probiotic, as well as identifying any potential risks associated with its use. This includes demonstrating that the probiotic is safe for consumption and that it has a beneficial effect on human health. The scientific evidence required for registration includes data from clinical trials, observational studies, and in vitro studies. The EFSA also considers the strain-specificity of the probiotic, meaning that the probiotic must be identified to the species and strain level and that the strain must have been safely used in food or food supplements before. Once a probiotic has been registered with the EFSA and received a positive opinion, it can be marketed in the EU as a food supplement. The probiotic must also comply with EU regulations on food labeling and composition. It's important to note that the EFSA's opinions are not legally binding, but they are used as the basis for decisions by the European Commission and by national authorities regarding the authorization and/or withdrawal of probiotics in the EU.

 

In Canada, probiotics are considered natural health products and are regulated by Health Canada under the Natural Health Products Regulations (NHPR). These regulations were created in 2004 to ensure that natural health products available for sale in Canada are safe, effective, and of high quality. For a probiotic product to be sold in Canada, it must first be licensed by Health Canada. This involves submitting an application for a product license, which includes providing safety and efficacy data to support the product's claims. Manufacturers must also provide information on the probiotic strains used in the product, as well as their intended use and recommended dose. Health Canada reviews the data provided in the application to ensure that the product is safe for consumption and that the claims made about the product are supported by the evidence. Once a product is licensed, it is assigned a Natural Product Number (NPN), which must be displayed on the product label. This indicates that the product has been reviewed and approved by Health Canada for sale in Canada. Overall, the regulations ensure that probiotics sold in Canada are safe and effective for their intended use, and give consumers confidence in the products they purchase.

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In conclusion, the regulation of probiotics varies by country and it is important to understand these regulations to ensure that the probiotic products you are using are safe and effective. The United States, European Union, and Canada all have different regulations and oversight for probiotics. The FDA regulates probiotics as dietary supplements in the United States, the EFSA regulates probiotics as food products in the European Union, and Health Canada regulates probiotics as natural health products in Canada. It's important to ensure that the probiotic products you are using comply with the regulations of your country and have been evaluated for safety and efficacy by the appropriate regulatory agency.