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USDA Organic Certification and Organic Empty Capsules

USDA Organic Certification and Organic Empty Capsules

Are you familiar with USDA Organic certification? Do you know how organic empty capsules are produced on the market? Let Lefan Capsules tell you.

What is USDA Organic Certification

In the 1980s, multiple organizations in the United States provided certification for different and often conflicting organic standards. Coupled with fraud and resulting consumer mistrust, this situation prompted a demand for federal standards and regulation. The Organic Foods Production Act of 1990 established national standards for the production and handling of organic agricultural products. The act authorized the United States Department of Agriculture to create the National Organic Program (NOP), responsible for establishing and ensuring compliance with USDA organic regulations.

“Organic” is a labeling term that indicates food or other agricultural products are produced following USDA organic regulations. These standards require the integration of cultural, biological, and mechanical practices that foster cycling of resources, promote ecological balance, and conserve biodiversity. This means that organic operations must maintain or enhance soil and water quality while also conserving wetlands, woodlands, and wildlife. The use of synthetic fertilizers, sewage sludge, irradiation, and genetic engineering is prohibited.

Organic certification verifies that farms or handling facilities anywhere in the world comply with USDA organic regulations and are allowed to sell, label, and represent their products as organic. These regulations describe the specific standards needed to use the “organic” term or the USDA organic seal on products.

The USDA recognizes four categories of organic production:

① Crops – plants harvested for food, livestock feed, or fibers.

② Livestock – animals used for food or in the production of food, fibers, or feed.

③ Processed/multi-ingredient products – items that are processed and packaged (such as chopped carrots) or combined, processed, and packaged products (such as bread or soup).

④ Wild crops – plants that are not cultivated. Organic empty capsules fall under the third category of processed/multi-ingredient products.

To gain certification, manufacturers must submit an organic certification application to a USDA-accredited certifying agent, which could be a governmental, private, or foreign organization, and bear certain costs. Organic certification needs to be renewed annually. The certifying agent will charge for recertification and the updated application (including the Organic System Plan, OSP) to reflect any changes since the initial certification. The agent will also arrange for a qualified inspector to visit the site to verify compliance with the updated OSP, maintain proper records, and meet all OSP requirements.

USDA organic certification labels are more than just a simple mark. Depending on the percentage of organic ingredients in the product, they are divided into four different categories:

  • “100% Organic”: This means that all ingredients in the product are certified organic and free from any components listed on the National List of Allowed and Prohibited Substances. The USDA organic seal can be used on packaging.
  • “Organic”: These products contain at least 95% organic ingredients, with the remaining 5% non-organic ingredients being non-GMO and included on the national list of allowed substances. The USDA organic seal can be used on packaging.
  • “Made with organic ingredients”: These products contain 70% to 95% organic ingredients. Unlike the first two categories, they cannot display the USDA organic seal on packaging but can list up to three ingredients.
  • “Less than 70% organic content”: These products contain less than 70% organic ingredients but can still label the organic components on packaging. However, they cannot display the USDA organic seal or claim organic certification.

What are Organic Empty Capsules

In USDA Organic certification, empty capsules fall under the category of processed/multi-ingredient products. Organic empty capsules are:

  • Formulated primarily with organic pullulan, processed with appropriate excipients;
  • Organic pullulan is legally obtained from certified manufacturers, and the use of excipients adheres to the federal regulations of 7 CFR Part 205, which includes the National List of Allowed and Prohibited Substances.
  • Organic empty capsules do not contain any chemically synthesized substances, are all natural source ingredients; free from allergens, GMOs, and gluten.
  • Currently, the known organic empty capsules contain >95% organic components;

Manufacturing Process

  • The manufacturing process is conducted entirely according to organic product procedures;
  • Non-organic and organic products are strictly segregated during production, with involved production equipment and containers clearly marked and distinguished;

Quality Control

  • Inspections and release of raw materials, intermediates, and finished products are conducted according to procedural documents;
  • Regular inspections for agricultural residues in organic empty capsules are conducted, referencing USP <561>;
  • Regular testing for heavy metals in organic empty capsules is conducted, referencing USP <232> and USP <233>;
  • Regular GMO testing of organic empty capsules is conducted, referencing ISO 21569:2005/Amd1:2013;

Certification Compliance

  • Manufacturers of organic empty capsules can provide organic certification certificates;
  • On the USDA website, you can retrieve information about certified organic products or businesses;
  • Companies processing organic products in the United States also need to apply for organic manufacturing permits from their state health departments.

This introduction covers USDA Organic certification and organic empty capsules, noting that in the current market, only pullulan empty capsules that meet USDA Organic certification requirements (>95%) can be certified as organic products. Organic pullulan empty capsules, as an essential adjunct in health product capsules, offer consumers a safer, greener, and healthier choice.

It is important to note that as a critical adjunct in pharmaceutical capsules and dietary supplement capsules, the safety of empty capsule products and compliance with the production process are essential; thus, the users/final consumers need to audit/pay attention to whether empty capsule manufacturers are within the regulatory scope of the food and drug regulatory authorities in the production and sales countries, are legal and compliant enterprises, and that empty capsule products also need to be registered with the food and drug regulatory authorities.


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