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CFR 111 Certification Protects Supplement Package Integrity

Bringing goods to market involves several considerations for producers, who make merchandising, branding, and packaging decisions for their products.  If you are a food producer, additional safe handling measures must also be addressed, ensuring the quality and purity of the products you place on shelves.

The Federal Food, Drug and Cosmetic Act of 1938 grants specific power to the Federal Government for regulating how food is to be treated,  outlining best practices for handling human food and edible supplements.  The Act defines quality as: Consistently meets established specifications for identity, purity, strength, and composition and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration.  That means food and supplements must be handled safely during every production phase, including packaging.

Code of Federal Regulations

The 1938 Act was written in response to a safety breakdown, which led to fatalities among users of improperly produced medicine.  Since its inception, the Act has been amended many times, responding to specific concerns about food, drug, and cosmetics safety.  The Code of Federal Regulations (CFR) spells out each responsibility, furnishing a blueprint for manufacturers and other food handlers to follow.

CFR 110, for example, specifically governs how human food is produced, packed and stored, hedging against contamination and adulteration at each handling stage.  Packaging providers comply with CFR 110 by having facilities, equipment, and practices that meet regulatory thresholds.   If you are a food producer, working only with contract packagers exhibiting the highest possible food safety standards is essential.

CFR 111 for Dietary Supplements

Dietary supplements continue to grow as an industry, so the Code of Federal Regulations addresses supplement handling separately from other food products covered by CFR 110.  CFR 111 outlines current Good Manufacturing Processes (GMP) for manufacturing, packaging, labeling, and holding dietary supplements.  Regulations specifically address categories like:

  • Personnel
  • Physical Plant and Grounds
  • Equipment and Utensils
  • Production and Process Controls
  • Quality Controls

While sanitation and safe handling comprise a big part of compliance, regulations also address record-keeping and batch monitoring standards, requiring producers to document manufacturing processes and maintain accurate data about each batch produced.  Laboratory operations also fall under CFR 111, requiring certain standards to be met in testing products.

Dietary Supplement Packagers are regulated like producers, maintaining integrity throughout the supply chain.  CFR 111 sets safe handling standards for processes such as:

Packagers’ components, packages, and labels are subject to review. Still, regulations also set standards for packagers to follow, relating to the actual items they receive to package and label as dietary supplements.

To maintain quality, purity, and safety during packaging, providers submit to periodic audits conducted by third-party verification agencies.  CFR 111 certification ensures your packager meets current minimum GMP standards, attesting to high standards in packaging dietary supplements.  While many packagers implement even more rigorous in-house standards, certification provides tangible feedback as you address your supplement packaging needs.

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