How Regulations and Needs Differentiate OTC and Dietary Supplement Packaging Selection Processes

Over the counter (OTC) drugs and dietary supplements are all available without prescription, yet regulatory requirements for each category are quite different. The Food & Drug Administration (FDA) mandates testing and other measures of proof of an OTC drug’s safety and efficacy before it can be legally distributed in the United States.

On the other hand, dietary supplements are essentially unregulated by the FDA with the exception of when new non-food substance ingredients are introduced into a supplement or nutraceutical. The FDA then needs rationale as to the safety of the new ingredient(s).

The disparity in regulatory oversight impacts a manufacturer’s approach to OTC and nutraceutical packaging. Understanding why and how this occurs is essential for decision making and operational efficiencies, as does working with an expert packaging partner such as Amcor.

OTC packaging regulations and recommendations

OTC drugs are regulated by the FDA for safety, effectiveness, and quality using a monograph system. The monograph places parameters around active ingredients, uses, doses/administration, labeling, and testing. This specificity aids in appropriately categorizing the OTC drug and establishing its safety and effectiveness.

Along with the monograph comes specific FDA Code of Federal Regulations (CFR) Title 21 requirements that spell out current good manufacturing practices for finished pharmaceuticals, including packaging and labeling.

Subpart G of FDA CFR Title 21§211 pertains to packaging and labeling for OTC drugs labeled and marketed in the United States. It specifies the need for:
Written procedures for the storage, handling, sampling, examination, and testing of labeling and packaging materials

• Written procedures for and visual inspection of labels, labeling, and packaging materials to prevent mix ups and cross-contamination as well as suitability and correctness of packaging and labeling materials prior to use
• Facility evaluations to inspect and verify quality control systems
• Tamper-evident packaging that aligns with child-resistant packaging requirements laid out in the Poison Prevention Packaging Act of 1970

The FDA’s stringent and intentional regulation around packaging quality control for OTC drugs informs decisions about packaging production. Processes are governed by more stringent quality control measures, including Poison Prevention, ISO, and current Good Manufacturing Practices (cGMP). Regulatory requirements may also impact how quickly a supplier is able to react to changing market demands and/or new product introductions.

Risk mitigation is a top priority for OTC brands, which can narrow choices in packaging materials, formats, and suppliers. In some cases, maximizing OTC packaging performance and safety could lead to over engineered packaging without guidance from an experienced packaging partner.

Drivers behind dietary supplements packaging

In 1994, Congress amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to include the Dietary Supplement Health and Education Act (DSHEA), which exclusively addresses dietary supplements.

Under DSHEA, dietary supplements and their equivalents are specially classified within the FDA’s general “foods” category because they contain “dietary ingredients” (e.g., amino acids, vitamins, minerals, etc.) intended to target dietary welfare. The substances in dietary supplements and nutraceuticals are considered part of the food supply. Pills, tablets, capsules, gummies, softgels, liquids, and powders covered under DSHEA are exempt from FDA safety and effectiveness regulations.

However, there are exceptions. DSHEA-defined products may be excluded from the dietary supplement category and redefined as a drug if they are:

• Specifically intended and labeled for treating a specific disease
• Licensed as biologics
• Made with a “new” non-food ingredient
• Subject to evaluation under an investigational new drug application

The manufacturer is responsible for ensuring its products are correctly formulated, labeled, and branded — misrepresentations are violation of federal law, which triggers a separate FDA action to enforce those laws. Further, any supply chain vendors that manufacture, package, or hold supplements are governed by FDA good manufacturing practices requirements that ensure accurate identity, purity, quality, strength, and composition.

There is latitude in what constitutes dietary supplement safety and effectiveness, as well as fewer regulatory requirements for their packaging although Poison Prevention mandates mirror that of OTC. As a result, dietary supplement brands are freer to collaborate with packaging experts such as Amcor to explore alternative packaging materials and formats that increase customer appeal for existing and new products.

Compliant packaging solutions for dietary supplements and OTC drugs from Amcor

With guidance from a world leader in packaging such as Amcor, manufacturers can work toward successful compliance with materials and processes, including:

• Packaging materials compatibility with dietary supplements and OTC drugs, including drug stability and shelf life considerations
• Packaging formats that offer tested and appropriate barrier protections
• Inclusion of more sustainable packaging solutions in terms of alternate material choices, shorter processes, lower carbon emissions, and potentially less stress on resources and waste streams