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FDA - The Basics
What is FDA?
FDA (The Food and Drug Administration) is one of several public health agencies, and it is charged with protecting American consumers from certain types products that are not safe, pure, and effective. In order to accomplish this, FDA conducts inspections of the nation's 95,000 regulated businesses using its 1100 investigators. These employees are located in district and local offices in 157 cities across the country.
FDA is an agency of the Department of Health and Human Services, which is part of the executive branch of the federal government. (Click here to see HHS organizational chart.) FDA enforces laws enacted by Congress which deal with the regulation of food (excluding red meat and poultry), drugs, medical devices, blood, biological products, and cosmetics. In order to do this, FDA issues regulations, which specify how the law will be enforced.
FDA also employs 2100 scientists, including 900 chemists and 300 microbiologists, who perform various duties relating to consumer protection, including testing samples taken during inspections, reviewing scientific evidence submitted by companies as they try to gain approval for new products, testing the safety of the nation's food supply and investigating the biological effects of commonly used chemicals.
For more information on FDA, click here.
What Are the Laws Enforced by FDA?
FDA acts under laws passed by Congress, and therefore derives its authority ultimately from Congress through these laws. FDA's roles and responsibilities are limited to the scope of the laws which Congress has enacted and which have been assigned to FDA for enforcement. All the safety standards enforced under these laws apply to imported as well as domestic products. The U.S. Bureau of Customs works closely with FDA to ensure that all requirements are met by foreign products. To see the full text of all the laws enforced by FDA, click here. The laws summarized below form the basis for the overwhelming majority of FDA activities:
The Federal Food, Drug, and Cosmetic Act of 1938 is intended to assure the consumer that:
 | foods are pure and wholesome, safe to eat, and produced under sanitary conditions |
| drugs and medical devices are safe and effective for their intended uses.
This includes drugs used in medicated feeds for animals.
| cosmetics are safe and properly labeled.
| packaging and labeling of these products is truthful and informative. | |
The Federal Food, Drug, and Cosmetic Act replaced the first food and drug act passed by Congress in 1906. Since 1938, the FD&C Act has been amended several times. Among the more prominent amendments have been the following: the Food Additives Amendment of 1958, which prohibits the introduction of new food additives until the manufacturer can prove their safety; the Color Additive Amendments of 1960 which gave FDA authority to control the conditions for safe use of a color additive, including the amount of color used in a product; and the Drug Amendments of 1962, which required among other things that all drugs be proven effective as well as safe and gave FDA the authority to regulate prescription drug advertising (over the counter drug advertising is regulated by the Federal Trade Commission); and the Medical Device Amendments of 1976, which gave FDA authority to ensure the safety and effectiveness of medical devices, including diagnostic products. The 1976 amendments also require manufacturers to register with FDA, follow quality control procedures, and obtain pre-market approval for certain types of devices
The Fair Packaging and Labeling Act of 1966 requires that the net weight be accurately stated in a uniform location on the label. This law strengthened the Food, Drug, and Cosmetic Act.
What is the Difference Between a Law and a Regulation?
A statute or law is enacted by Congress. It contains, for the most part, some general principles, although in some instances, it also contains specific requirements. For example, the Federal Food, Drug, and Cosmetic Act states generally that no food labeling may be "false or misleading in any particular." It also specifies that the name and address of a manufacturer shall appear on the label.
In both instances, it is necessary for the Food and Drug Administration to issue implementing regulations that will inform industry and the public exactly how those provisions will be applied. For example, FDA issued a regulation stating exactly where on the label, and in what type size, the name and address of the manufacturer must appear. Industry has to comply with these regulations, which means in effect that an executive agency of the Government is applying in practical day-to-day terms what Congress intended.
All regulations issued by the Agency are enforceable in the courts. The basic issue in any enforcement action is whether the regulations are "reasonable," and are not "arbitrary and capricious." There have been exceptions, but most of the regulations have been upheld in courts as being reasonable, and thus have been enforced as legal requirements.
What is GMP?
GMP stands for Good Manufacturing Practice. It refers to the regulations that FDA has promulgated under the Federal Food, Drug, and Cosmetic Act to ensure that products are manufactured and held in a state of control, thereby contributing to their safety, effectiveness, and purity. GMP regulations exist for the following industries: food, drug, medical device, blood, medicated feeds, and type A medical products. The medical device GMP regulation has recently been renamed the The Quality System Regulation in order to use language which more easily harmonizes with other international GMP standards.
GMP regulations assist all employees in knowing what is necessary to help ensure the success of your company by setting quality standards. It is therefore very important for everyone to be familiar with the regulations, and to do his/her part to ensure that only products of the highest quality are manufactured. This not only protects the health of the consumer (which is all of us), but it also contributes to the good reputation of your company, allowing for continued success in the marketplace.
How Does FDA Decide When To Issue Or Change a Regulation? What Participation Do the Public and Industry Have in This Process?
Ideally, the Agency will issue a regulation whenever it arrives at a policy decision that directly affects the public or the regulated industry. Federal law requires that every regulation, except procedural regulations, must be published as a proposal in the Federal Register for public review and comment before it is promulgated in final form. FDA ordinarily allows at least 60 days for industry and the public to review a proposed regulation, and write the Agency with comments and suggestions.
After these comments are received, the Agency analyzes them and prepares a detailed preamble to the final regulation which states the nature of each type of comment received and explains the reasons for the Agency's decision. Upon final promulgation, the regulation is then enforceable in the courts.
See also How To Comment On Proposed Regulations, Federal Register Reader Aids, and How To Participate in Agency Making Decisions.
Also, anyone can petition FDA if they feel that the Agency is overlooking something important. To learn more about petitioning FDA, read How to Petition the FDA.
What Happens if We Don't Comply With FDA?
There are two ways to achieve the objectives of any law: (1) by informing and educating the regulated groups so they will not do what is forbidden; and (2) by taking action in the courts if the law is broken. Both approaches used together do a better job than either one can do alone.
First FDA uses every possible means to make sure the industry knows the full requirements of the law. Correspondence, conferences, speeches, publications, exhibits, and individual counseling are all used by FDA to inform manufacturers and shippers. This is sometimes called "preventive enforcement." In this way violations are kept to a minimum.
However, when FDA discovers by inspection, laboratory analysis, or consumer/health provider complaint that a product that has crossed state lines does not conform to the law, the Agency has several legal recourses which it can take:
Seizure
The seizure of a food, drug, cosmetic, device, or biological product that violates the Federal Food, Drug, and Cosmetic Act is an action taken against the product, not against the owner. Its purpose is to prevent consumption or use of the seized product. The Supreme Court has described a seizure action as "stopping the bullet in flight."
When by inspection and laboratory analysis, FDA discovers that a product that has crossed state lines does not conform to the law, the Agency requests the U.S. Department of Justice to file a "libel" with the proper Federal court. Acting on a warrant issued by the court a U.S. marshal (usually accompanied by an FDA official) then seizes the articles. The owner is notified, and given an opportunity to appear in court to contest the government's charges if he/she believes them in error.
If the owner of the seized products fails to appear in court, the case is disposed of "by default." This means that the court accepts the charges of FDA that the products involved do violate the law, and no one challenges them. The court may then order the products destroyed or otherwise disposed of. A food that was mislabeled might be given to charity, for example.
Or the owner may appear in court, admit that the product violates the law, and request that he be given the opportunity to recondition it - that is, bring it into compliance with the law. In this event, a "consent decree of condemnation" is issued, which means the owner puts up a bond - cash value more than twice the value of the goods - to assure his compliance. The court releases the goods to the owner for reconditioning, relabeling, or whatever else is necessary. An FDA official supervises the reconditioning operation, at the owner's expense. The results are reported to the court. All good (legal) merchandise is given back to the owner for his/her disposal; if there's any remainder of the product that still fails to meet legal requirements, it is destroyed.
Criminal Prosecution
Besides having his/her offending goods seized, which may be no small penalty, the person or firm responsible for violating the Federal Food, Drug, and Cosmetic Act may be subjected to a criminal prosecution. The principal penalties imposed upon defendants are a year in jail and a $100,000 fine, (or up to $250,000 fine if death resulted,) for each shipment made or act committed that was in violation of the law. Multiple counts may result in a maximum fine of $500,000 from a single event. Repeat violations or violations involving fraud carry a $250,000 fine and a three year jail term per count.
Injunction Proceeding
Another legal weapon that the Food and Drug Administration has been authorized by Congress to use is the injunction or restraining order. This is especially useful when a person or a firm has a record of repeated violations. Injunctions frequently are issued to prevent the shipment of a product prepared under unsanitary conditions disclosed through factory inspections. In these cases the order not only enjoins interstate shipment of the unfit product, but of any product prepared in that factory until it has been brought into satisfactory sanitary condition.
An essential part of the Government's case in an injunction action is to show that if the injunction is not issued, another violation will probably occur. The FDA can apply to Federal District Courts for an injunction which forbids shipment of an offending product through interstate commerce. Violation of the injunction then amounts to contempt of court, and may be punished accordingly. The judge has great discretion in determining the severity of such punishment. The law requires FDA to publish the results of all of its court cases.
