Manufacturers and importers must consider numerous product safety regulations in their operations. This applies in particular to such goods as food, medicines, cosmetics, and medical devices. Within the European Union, compliance with EU directives is of utmost importance. In turn, in the United States, these issues are regulated by the Food and Drug Administration (FDA). This article discusses the scope of the FDA’s activities and its correlation with other markets.
The Food and Drug Administration was founded in 1906. It is a U.S. Government institution that is financed by about 80% of the state budget. FDA regulates and supervises the food, pharmaceutical, and medical device markets in the United States. The FDA’s approval of a product indicates both its safety and effectiveness, mainly as a result of the rigorous standards applied by the FDA.
FDA scope of operation
The FDA’s mission to promote and protect public health is accomplished by regulating and supervising the markets of food products, dietary supplements, medicines (prescription and over-the-counter), vaccines, blood products, medical devices, tobacco, veterinary products, and electromagnetic radiation-emitting devices.
In particular, the FDA regulates and supervises:
- Foods, including dietary supplements, bottled water, food additives, and others
- Medicines, including prescription drugs and non-prescription (OTC) drugs
- Biologics, including vaccines, blood and blood products, cellular and gene therapy products, tissue, allergenics
- Medical devices, including simple items, such as tongue depressors or pregnancy test kits, and complex technologies, such as heart pacemakers, dental devices, surgical implants and prosthetics
- Electronic products that emit radiation, including microwave ovens, x-ray equipment, laser products, ultrasonic therapy equipment, sunlamps
- Cosmetics, including colorants, skin moisturizers and cleansers, nail polish, and perfume
- Veterinary products, including livestock feeds, pet foods, veterinary drugs and devices
- Tobacco products, including cigarettes, tobacco, smokeless tobacco.
In this respect, the FDA, among other things, draws up laws and regulations, approves products of certain categories to be introduced to the market, educates, monitors the market, and conducts inspections.
Products that require FDA approval:
- New food additives;
- Color additives used in food, drugs, cosmetics, and some medical devices;
- Class III medical devices (the devices of highest risk that sustain or support life, or are implanted, such as implantable pacemakers and breast implants);
- New medicines, including OTC drugs, if they do not conform to an OTC Monograph (a publication that regulates acceptable drug ingredients, dosing, etc., which can be found in section 300 of the Code of Federal Regulations).
For many products (e.g. cosmetics, food, beverages, or dietary supplements), FDA approval is not mandatory. However, any manufacturer that markets food products, medicines (including veterinary drugs), biologicals, tobacco products, and medical devices in the US, must register their company with the FDA and renew their registration every year.
In addition, manufacturers operating in the US market are required to comply with Current Good Manufacturing Practices (CGMPs) published by the FDA, as well as with its requirements for label content. FDA enforces these obligations through inspections to which it is entitled.
How to obtain FDA approval for a product
As regards the Food and Drug Administration’s activities, they refer mainly to documents approving a given product, rather than typical certificates. Therefore, the FDA logo cannot be placed on products and packaging, even if they have been approved. However, they can be marked with an „FDA approved” sign, provided that appropriate confirmation from FDA was received. When introducing FDA-supervised products, it is the registration and optional approval (required for products listed in the previous section) that are crucial.
The registration process varies according to the product group. Detailed guides for each of them can be found on the fda.gov website. For example, when registering a pharmaceutical company, making a list of all drugs that it will introduce to the US market is necessary. The registration is carried out online. Furthermore, foreign companies always have to designate their representative in the US. The registration obligation does not apply to most cosmetic manufacturers. It should be noted that the registration itself is not equivalent to the FDA’s approval.
If you plan to introduce one of the products that require approval to the US market, you should apply for approval after registering in the system. Again, different standards apply depending on the product group. To exemplify, Class III medical devices will require a so-called Premarket Approval (PMA). In the application process, the safety and effectiveness of the product to be introduced must be proven. This should be supported by reliable clinical tests.
What is important, the FDA only reviews reports from previously conducted tests but does not conduct them on its own. According to the FDA’s declaration, a review should take around half a year to be issued (as for new medicines).
FDA and CE
FDA approval has no formal or legal significance in the European Union. For some articles covered by the FDA supervision, the CE (Conformité Européenne) marking applies in the EU. The application procedure does not change to any account, even if the FDA has previously approved a given product.
Medical devices, especially electrical equipment, are a group of products covered by both FDA and CE regulations. CE certification does not concern food, drugs, or cosmetics, which is the basic difference between the two markings.
If a medical device carries both the CE certificate and FDA approval, this indicates that the brand is prestigious and safe. For this reason, some manufacturers strive to obtain both markings, even if the FDA regulations do not apply to their market. Exporters planning to introduce certain groups of articles to the US market must, in turn, meet the requirements of the Food and Drug Administration, even if they have previously obtained the CE certificate.