What is FDA?

The Food and Drug Administration (FDA) is a federal government agency within the U.S. Department of Health and Human Services. FDA administers the Federal Food, Drug, and Cosmetics Act (FFDCA), which is a law amended over time (beginning in 1906) that gives the U.S. federal government its authorities to regulate food, food additives, drugs, medical devices, and cosmetics.

The definitions of items regulated by the FDA are broad enough to encompass some Avery Dennison products and materials. For instance, the definition of food additive generally includes food and beverage packaging and other materials that come into contact with food and beverages. Medicals devices include not only technologically sophisticated items (e.g., pacemakers and radiation therapy equipment), but also simple items such as bandages and ice bags.

Medical Devices

Medical device means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:

recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, or
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
intended to affect the structure or any function of the body of man or other animals, AND

which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Note that the definition is broad and includes components. Medical devices can range from simple devices like bandages and tongue depressors to high-tech equipment like pacemakers. Medical devices also include in vitro diagnostic products, such as medical lab equipment, reagents, and test kits.

Medical devices are categorized into Class I, II, or III.
Class I	Class II	Class III
A medical device relevant to Avery Dennison would likely be a Class I or Class II device. For instance, bandages are usually Class I and medical bags are usually Class I or Class II, depending on the application.	Premarket Notification (510(k)) is required for Class I and II devices, unless exempt. Many Class I and II devices are exempt, subject to limitations. When a 510(k) is required, an FDA letter declaring the device substantially equivalent to another legally marketed device must be received before the device can be marketed.	Premarket Approval (PMA) is required for Class III devices, and is a more extensive process than premarket notification.

Manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments annually with the FDA and provide a listing of devices.

Facilities and methods related to designing, purchasing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices must follow FDA's Quality System Regulation (QS)/Good Manufacturing Practices (GMP).

Other requirements for medical devices include requirements for labeling, reporting incidents, post-market surveillance, device tracking, and import and export. See the Medical Devices Flowchart for more detailed explanation of medical device requirements.

The materials available and information provided at the Avery Dennison ADvantage: Complete Compliance site are for informational purposes only and not for the purpose of providing legal advice.

Cosmetics

Cosmetics are articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance.

Examples of products included in this definition are:
skin moisturizers	perfumes	lipsticks	shampoos
hair colors	toothpastes	fingernail polishes	permanent waves
body art products	deodorants	eye and facial makeup preparations
As well as any material intended for use as a component of a cosmetic product.

The FFDCA in general prohibits the marketing of adulterated or misbranded cosmetics in interstate commerce. Cosmetics that are adulterated or misbranded may be subject to FDA action.

Adulterated cosmetics include those that contain substances injurious to users, contain or are handled in unsanitary conditions, or that are in containers that contain substances injurious to users.

Misbranded cosmetics include those with false or misleading labeling, labels that lack required information, or have containers that are formed or filled in a misleading manner.

Cosmetics are subject to the federal Food Packaging and Labeling Act (FPLA), and cosmetics that fail to comply with the FPLA are considered misbranded under the FFDCA.

The cosmetics regulations mainly address color additives, which must be approved for use in cosmetics. Any business that produces cosmetics or materials for them needs to ensure that any color additives are used in accordance with uses and restrictions specified in the regulations.

All color additives used in cosmetics (or any other FDA-regulated product) must be approved by FDA, and there must be a regulation specifically addressing a substance's use as a color additive, specifications, and restrictions. In addition to approval, a number of color additives must be batch certified by FDA if they are to be used in cosmetics (or any other FDA-regulated product) marketed in the U.S. All color additives must meet the requirements for identity and specifications stated in the regulations, and color additives may be used only for the intended uses stated in the regulations. The regulations also specify other restrictions for certain colors, such as the maximum permissible concentration in the finished product.

FDA's legal authority over cosmetics is different from other products regulated by the agency, such as drugs, biologics, and medical devices. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives.

The materials available and information provided at the Avery Dennison ADvantage: Complete Compliance site are for informational purposes only and not for the purpose of providing legal advice.

Food Ingredients and Packaging

The most common case in which FDA requirements may be applicable to Avery Dennison materials and products is for food contact substances. Food contact substance (FCS) means any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food, if use of the substance is not intended to have any technical effect in such food. An FCS can be considered an indirect additive (see below). There are specific FDA requirements for FCSs. See the FCS flowchart. Manufacturing conditions for food contact products need to meet general standards of suitable purity for the intended use.

Food additive means a substance, the intended use of which results or may reasonably be expected to result, directly or indirectly, either in its becoming a component of food or otherwise affecting the characteristics of food.

There are several categories of food additives:

A direct additive is intended to have a technical effect on food. Approved direct additives are listed in 21 CFR Part 172.

A secondary direct additive is intended to have a technical effect during food processing, but not in the finished food as consumed. Approved secondary direct additives are listed in 21 CFR Part 173.

An indirect additive in intended to have a technical effect in (e.g., be a component of) a food contact material. Approved indirect additives are listed in 21 CFR parts 175 – 178. The regulations contain separate sections for adhesive and coatings; paper and paperboard; polymers; and adjuvants, production aids, and sanitizers.

Any substance that is added to food and imparts color to the food is a color additive.

Food additives need to be cleared by FDA, either through listing in 21 CFR Parts 173-186, or submission of food additive petition or food-contact notification. See the FCS flowchart for additional information on exemptions as relevant to FCSs. FDA's Center for Food Safety and Applied Nutrition (CFSAN) implements many other programs to regulate the food supply, the content of food labeling, and dietary supplements. Product labels, literature, and other information should not make general approval claims such as "Approved by FDA."

Food Ingredients and Packaging

In some cases it may be necessary to submit a food contact notification (FCN) to FDA before manufacturing or using a food contact substance (FCS). An FCN generally is not necessary if the substance is listed as a food additive in 21 CFR Parts 173-186 or meets exemption conditions. See the Food Contact Substances Flowchart for additional information on exemptions.

A manufacturer or supplier of an FCS may submit an FCN to FDA. If FDA does not object in writing, the FCN clears in 120 days, and the submitter and its customers may market the substance for the described use. Under certain circumstances (related to increase in dietary intake or potential carcinogenicity), a full petition may be required for an FCS. FDA has issued guidance on FCNs.

FCNs are proprietary and apply only to the submitter and its customers. Persons who purchase a food contact substance manufactured or supplied by a manufacturer or supplier identified in an effective notification may rely on that notification to legally market or use the food contact substance for the use that is the subject of the notification, consistent with any limitations in that notification. FDA's keeps a database Inventory of Effective Food Contact Substance (FCS) Notifications.

FCNs require information on chemical identity, intended conditions of use, intended technical effect, estimation of dietary intake, and toxicity and environmental information.

There are two types of FCNs:

Notification for a new use of a FCS (Form 3480).

Notification for the use of an FCS formulation (Form 3479). This is used to verify that components of a formulation may be used when there is no new FCS (or new use of an FCS) in the formulation.

A new FCN is necessary:
when substantive changes are made to specifications for the FCS; and	for a manufacturer other than the specified manufacturer;
when changes are made in the manufacturing method that result in substantive changes in the identity of the product or its impurities.

The materials available and information provided at the Avery Dennison ADvantage: Complete Compliance site are for informational purposes only and not for the purpose of providing legal advice.

Drugs and Biologics

*A drug* includes:**
articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them;	articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;
articles (other than food) intended to affect the structure or any function of the body of man or other animals; and	articles intended for use as a component of any articles specified above.

There are certain exemptions for food and dietary supplements.

The FDA Center for Biologics Evaluation and Research (CBER) regulates vaccines, blood, and biologics. This category includes a variety of products including blood bank devices, cellular and gene therapy products, allergenics, and others. The FDA Center for Drug Evaluation and Research (CDER) is the main entity within FDA that implements drug regulations.

Reporting to the FDA is required for:
discontinuation of all marketing of a drug previously listed;	marketing of a new drug not reported previously;
revised labeling for a previously listed product.	the start of marketing of a drug previously discontinued;
modifications or additions to the information concerning a drug previously listed; and

New human or veterinary drugs (i.e., those with new intended uses or new chemical entities) need to be approved by the FDA for safety and effectiveness, and their labeling reviewed for accuracy and thoroughness.

Facilities that manufacture, repack, prepare, propagate, compound, or process a human or veterinary drug or human biological product are required to register with FDA and list every drug is in commercial distribution. FDA requires strict Current Good Manufacturing Processes (CGMPs) for drug products. Companies are required to report to FDA all serious, unexpected adverse drug experiences associated with the use of the drug product manufactured, packed, or distributed by the company.

The materials available and information provided at the Avery Dennison ADvantage: Complete Compliance site are for informational purposes only and not for the purpose of providing legal advice.

Other FDA-Regulated Products

FDA regulates product types beyond those addressed in the main categories of this Avery Dennison Central site. In addition to food and food packaging, drugs and biologics, medical devices, and cosmetics, FDA regulates:

Dietary supplements;
Pet food, veterinary products, and animal cloning; and
Radiation-emitting products.

Contact your business or corporate product compliance leader if you are unsure about how your particular product or material may be regulated.

The materials available and information provided at the Avery Dennison ADvantage: Complete Compliance site are for informational purposes only and not for the purpose of providing legal advice.

FDA Website