Customer Assurance Requests Becoming More Specific Says Keller & Heckman Partner at Seminar
Customer assurance statements for food-packaging materials are an important aspect of packaging law that should be carefully considered by manufacturers, explained Jeffrey Keithline, a partner in Keller and Heckman's Washington, D.C. office, during a presentation on providing and interpreting customer assurances.
Speaking at a Keller and Heckman LLP sponsored seminar, FDA 101 in One Day: Basics of Legal and Regulatory Requirements for Food Packaging in the United States, on June 21, in Houston Texas, Keithline provided an overview of the three major forms of customer assurances, gave examples of customer assurance letters, and addressed issues of liability. The three forms of customer assurance discussed included Section 303 are Guaranty letters, company letters of assurance, and third party confirmations.
Section 303 Guaranty letters, issued under Section 303(c) of the Federal Food, Drug and Cosmetic Act (FD&C Act), provide that no person shall be criminally penalized for introducing adulterated or misbranded food into interstate commerce if the person establishes a guaranty from the person to whom he received the article, in good faith, stating that the article is not adulterated or misbranded. FDA has provided further information about the guaranty and examples for language for such letters in 21 C.F.R. Sections 7.12 and 7.13. Although these letters may be helpful as a template for customer assurance statements, 303 Guarantee letters typically only protect against criminal penalties, are void if the product is further processed, and do not protect against seizure by the U.S. Food and Drug Administration (FDA).
The second type of customer assurance discussed was company letters of assurance. These are letters from a supplier to a customer stating that the packaging material complies with the FD&C Act and applicable regulations. Although there are no specific requirements for what an assurance letter should contain, generally, it should include: food type limitations, temperature conditions of use, thickness limitations, or other limits on the amount of a food contact substance in a finished article. The assurance should include sufficient information to permit the finished food contact article manufacturer to determine whether its product complies with any applicable limits on its use in food-contact applications.
Increasingly, there has been a trend toward specific assurance requests because customers want to know more about the composition of suppliers' products. Such requests generally regard the presence or absence of specific substances that customers do not want in packaging materials (e.g., phthalates), or a desire to limit certain levels of certain substances (e.g., heavy metals). The origins of some these requests include: FDA, California's Proposition 65, CONEG heavy metals limits, European Union (EU) Directives, intentional contamination, or the media.
Typical examples of substances of concern include aluminum, antimony, arsenic, asbestos, azo-based colorants, BPA, boron, brominated flame retardants, cadmium, chromium (hexavalent), dioxins, lead, magnesium, manganese, melamine, organotin compounds, PCBs, phthalates, and PVC.
In responding to these requests, manufacturers often require detailed knowledge of the raw materials in their formulas. Obtaining the requisite knowledge may even require contacting the supplier's supplier or testing to ensure the accuracy of responses.
The final type of assurance discussed was third party opinion letters. These letters can take the form of either official FDA concurrences or opinion letters from counsel. Although, FDA generally will not certify compliance, some customers want an explicit statement from FDA regarding compliance. The forms of FDA official concurrence that may be provided include an FDA food additive regulation, a threshold regulation exemption letter, an effective food contact notification, an FDA opinion letter, a prenotification consultation, or perhaps even FDA's response to a GRAS notification.
Opinion letters from counsel on FDA compliance, such as those issued by Keller and Heckman, are used to assure customers and assist with internal assessments. These opinion letters can be issued in long or short form and can be used to market many different products.
It important to note that, under the Uniform Commercial Code (UCC), company assurance letters may be considered enforceable warranties unless such warranties are expressly and conspicuously disclaimed. As such, liability can extend not only to consequential or incidental damage, but also from loss of future sales or damage to a brand's reputation. Given the potential impact of these letters, Keithline urged companies to consider limiting liability in assurance statements and limit who can issue compliance statements.
Keller and Heckman Partner Catherine Nielsen and Scientist Holly Foley also gave presentations at the workshop.