There are over 200 laws that regulate the labeling and packaging of consumer goods produced and distributed domestically and internationally. Packaging and labeling laws are in place to provide product safety and consumer confidence in the products available to them.
Packaging and labeling laws have two very distinct purposes. Product packaging laws focus on product transportation - ensuring the safety of and deterring the tampering with products as they make their way from the manufacturer to the retailer and finally to the consumer. Packaging laws also impose standards on the materials that are used for packaging, its dimensions and its durability.
Varying from one trade nation to another, packaging laws can often provide manufacturers with challenges. For instance, France has adopted and implemented new packaging laws which limit the amount of product packaging to only what is necessary to safely distribute the product. Germany, in their push towards sustainability, began by requiring manufacturers to take back and recycle or reuse all primary packaging. Then they added secondary packaging and finally made it obligatory for manufacturers to take back packaging used to distribute to consumers including cans, glass containers, and bottles.
If considering international trade, make yourself knowledgeable on the laws in various countries and make sure your product can pass. Not complying with the law is not an option.
Product labeling laws on the other hand help to ensure that consumers know what they are purchasing. They protect consumers from being misled with regard to the contents and/or the effects of the product. Predominantly for food and drug products, labeling legislation requires that specific information be included on the label; quantity, what the product is made up of, how it was manufactured, when and where it was manufactured, and its purpose.
As with packaging laws, compliance is essential. If your product is found to be out of compliance it could result in a criminal charge, fines, penalties, and removal of your product from distribution. Keeping up with the legislation and how it affects your product is important to the success of your product as well as your brand.
Natural Products Insider has a slideshow about the process of initiating a partnership with a contract manufacturer. The presentation is a useful guide specifically for dietary supplement companies (but applicable to others), so they know what to expect and what questions to ask. A summary is below.Outsourcing Benefits
Selecting the Right Partner
- Virtual Company
- Lead time
- Quality agreement
- Worker attitude?
- Level of GMP (Good Manufacturing Practice) compliance?
- Scientists employed?
- In-house testing?
- Methods and equipment?
- Incoming material qualification?
- Stability testing?
Crafting the Contract
- Requirements of target markets
- cGMP and similar certifications
- Rights and responsibilities
- IP rights
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From the University of Wisconsin Department of Family Medicine, here's a video presentation that seeks to explain what nutraceuticals are and how they can be assessed for quality.Topics
Watch on YouTube
- Definition of Neutraceuticals
- Explosion in Neutraceuticals
- Plant of Pill: Isolated Chemical or Synergy of Whole Food?
- Whole Plant vs. Active Ingredient?
- Label Indicators of Quality
- Good Manufacturing Practices
- U.S. Pharmacopeia
Current good manufacturing practices (cGMP) are production and testing practices that help ensure good quality medicine, medical devices or active pharmaceutical products. A company is subject to the dietary supplement cGMP rule when it manufactures, packages, labels, holds or distributes a dietary supplement product. Complying with cGMP rules can be a challenge for own-label distributors, companies that have their products contract manufactured. Natural Products Insider has published an extensive checklist for companies employing contract manufacturers, to help them make sure they are distributing cGMP compliant dietary supplements. Here are some highlights.Raw Materials and Packaging
- Are the raw materials and packaging components acceptable for use?
- Determining this may require audits and tests of suppliers' raw materials.
- Unstable raw materials may affect product shelf life.
- Plant and animal-sourced ingredients must meet higher purity and potency specifications and be free from contamination.
- All packaging components should be suitable to protect the product from tampering and for the product's likely storage conditions.
- Labeling issues are the leading cause of cGMP regulatory and legal actions.
- An expert in labeling regulations and laws for supplements should review product labels.
- Labeling issues include the required format, layout, font size/type and information.
- Statement of identity (name of the dietary supplement)
- Ingredient list
- Warning statements
- Storage conditions
- FDA-approved Health Claims
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- Is your company prepared for an FDA cGMP inspection?
- FDA inspections for cGMP compliance can be quite extensive and take a several days.
- Expect a thorough inspection of the facility, operations, components, quality control (QC), written procedures, and documentation/record keeping.
- Implement a compliance program before an FDA inspection.
- Have a contract manufacturing agreement that clearly delineates the Part 111 compliance obligations.
- Have written procedures required for your operations, and make sure the contract manufacturer has them as well.