Beyond Food Packaging: Customer Assurance for Drugs, Medical Devices, Cosmetics, Tobacco, and Toys
By Keller and Heckman LLP’s Packaging Practice Group
Customers can be provided with assurance, in a number of ways, that a food-packaging product has a suitable regulatory status for use in the United States. The various forms that assurance can take are discussed in "Customer Assurance for Food Packaging Materials: Points to Consider" (see link below).
In addition, however, customers may seek food-contact assurance for products that are not food-contact applications. Oftentimes, food-contact assurance is requested for items such as drug packaging, cosmetics packaging, medical device products or packaging, children's toys, or even tobacco packaging.
While food-contact assurance is not legally relevant for these non-food applications, it may help to establish the safety of the product, which can be very important in the marketplace and may help establish U.S. Food and Drug Administration (FDA) compliance in some cases. Furthermore, it may be particularly important in the international marketplace where specific regulations are not always available for certain countries, but usually a safety standard is in place.
Different regulatory schemes apply to packaging for drugs, medical devices, cosmetics, and tobacco, and to children's toys, and each regulatory scheme relates differently to customer assurance. These products all differ from food in that there are no regulations or other general clearances for types of materials that may be used in packaging for the products (or in the toys themselves). The significance of this difference for customer assurance is explored below.
Drug and Medical Device Packaging
In the case of drugs and medical devices, the safety and the suitability of the packaging are considered as part of the FDA's premarket approval process for the particular drug or device, if premarket approval is required.
A packaging supplier (and its suppliers) can provide the information to the drug or device manufacturer, which would then submit the information to FDA as part of the application for approval. More commonly, however, to protect proprietary information, packaging material suppliers will provide the information to FDA directly in the form of a drug master file (DMF) or device master file (MAF), and authorize drug and device manufacturers individually to reference the master files in their applications for FDA approval.
In the case of drugs, FDA must be able to determine that the packaging will not compromise the safety or effectiveness of the drug. Stability of the product (maintenance of labeled potency through the claimed expiration date) is an important issue in FDA's review of a new drug application (NDA). With regard to medical devices, there must be reasonable assurance that the device is safe and effective under the conditions of use prescribed, recommended, or suggested in the labeling.
FDA assesses whether packaging materials will adversely affect the safety or effectiveness of a drug or device on a case-by-case basis. Complete formulation information is required and food-contact compliance is not dispositive, although such compliance often is relevant to FDA's evaluation, particularly when the drug or device involves exposure through ingestion.
A few words are in order about DMFs and MAFs. Master files are completely voluntary filings; they are not required by FDA, but are allowed by the agency as a means of providing suppliers with protection for their confidential information. FDA assigns a number to each master file, but numbering does not imply that the agency has approved the packaging material-or even reviewed the file.
Historically, FDA has reviewed master files only when requested to do so by a drug or device manufacturer (who is authorized to reference the file by the company that submitted it) in connection with an application under review by FDA. Recently, FDA has inaugurated a program to review drug packaging DMFs even in the absence of a pending drug approval application to determine if the DMF has adequate information and to request any information that appears to have been omitted.
There are no detailed FDA requirements for the contents of a DMF or MAF. In view of the purpose of the master files, it is not surprising that FDA expects some confidential information about the packaging material to be included. Beyond that, and some basic information such as the name and address of the company and a contact person, it is really up to the supplier to determine what information to place in its master file. This decision involves a somewhat delicate balance between keeping the information as generic as possible to minimize amendments to the file when minor changes occur in the product or the manufacturing process, and avoiding delays in FDA review of a customer's application when more information must be requested.
FDA has a rather old (1989) "Guideline for Drug Master Files," which describes the basic format and general content expected in a DMF. In addition, FDA has provided fairly detailed guidance on the information required for approval of packaging for drugs (in the context of an application for approval of a drug product) in the May 1999 Guidance for Industry: "Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Documentation." This document is valuable to suppliers as an indication of the types of information that FDA wants about drug packaging, but the guidance is not intended to specify the contents of a DMF. A significant portion of the information, such as the compatibility of a packaging material with a particular drug, can only come from the drug manufacturer.
Packaging suppliers should not feel obliged to include in a DMF every type of information identified in the Container Closure guidance. DMFs and MAFs are not limited to packaging; they may be used to provide FDA with information about drug ingredients and medical device components as well. The issues associated with these other types of master files and the products they cover is beyond the scope of this article.
Cosmetics, and their packaging, are not subject to premarket clearance by FDA. The Federal Food, Drug, and Cosmetic Act simply requires cosmetics to be safe (not adulterated); their safety is the responsibility of the cosmetics manufacturer.
Of course, the safety of cosmetics products may be affected by their packaging, but as discussed previously, there are no regulations specifying substances permitted in cosmetics packaging materials.
The safety of cosmetics packaging generally must be determined by the cooperative effort of cosmetics manufacturers and packaging suppliers. The safety of packaging for cosmetics applications may be addressed in part by food- contact compliance, but other considerations will be involved as well. For instance, safety upon ingestion will be relevant to lipstick, but so will skin irritation effects. Packaging for cosmetics used around the eye must be evaluated for potential effects on that part of the body. The formulation of the packaging and the formulation of the cosmetic and its intended use must be evaluated together.
The Cosmetic, Toiletry, and Fragrance Association (CTFA) in Washington, D.C., has guidance on safety testing of cosmetics that also can be helpful to packaging suppliers.
As is the case with cosmetics, there are no specific safety regulations in place for tobacco packaging. Furthermore, FDA does not have jurisdiction over tobacco products. Rather, the manufacture of tobacco products is regulated by the U.S. Bureau of Alcohol, Tobacco, and Firearms (ATF). ATF's regulations mostly cover tax revenue and labeling requirements. In FDA's most recent attempt to gain regulatory control over tobacco products, the U.S. Supreme Court ruled that the agency did not have statutory authority to regulate tobacco products under the Federal Food, Drug, and Cosmetic Act. (See FDA v. Brown & Williamson Tobacco Corp., 153 F.3d 155, affd. 529 U.S. _____ (March 21, 2000)). Thus, legally, FDA food- contact compliance is not necessary (or relevant) for tobacco packaging products.
Nonetheless, tobacco companies generally demand FDA food-contact compliance for tobacco packaging. In this area, a suitable food-contact status typically fulfills the customer's requirements.
Packaging for Toys
The Consumer Product Safety Commission (CPSC) regulates children's toys under the Federal Hazardous Substances Act (FHSA) and the Consumer Product Safety Act (CPSA). FHSA covers the chemicals that may be used in the manufacture of toys and the labeling of those chemicals, while CPSA contains general safety requirements and general duty provisions.
Packaging for toys is not specifically regulated. However, packages that have independent play value, as well as the toys themselves, come under the regulations. FHSA forbids the presence of hazardous substances in toys. The act states that a "hazardous substance" is, among other things, any substance or mixture of substances which is toxic, corrosive, is an irritant, is a strong sensitizer, is flammable or combustible, or generates pressure through decomposition, heat or other means if such substance or mixture of substances may cause substantial personal injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable handling or use, including reasonably foreseeable ingestion by children.
Due to the possible ingestion of materials used in toys, toy manufacturers typically require food-contact assurance to support the safety of toy components. Generally, safety issues relate to toys themselves, not to the packaging. In this regard, depending on the customer's specific requirements, an opinion letter regarding the safety of the product for food-contact articles may be used to assure the customer of the safety of the product in relation to toys that may be mouthed by a child.
In summary, FDA food-contact compliance often is demanded for packaging materials for drugs, medical devices, cosmetics, and tobacco, as well as for materials used in the production of toys. In some cases, such food-contact compliance may be relevant (and even sufficient) for non-food products. In many instances, however, establishing compliance involves considerations beyond suitability for food packaging.