The US-FDA or United States’ Food and Drug Administration is a federal agency of the United States. It is administered by the Department of Health and Human Services It is a regulatory authority, which is responsible for the safety of public health, by maintaining stringent regulations for various products used in the US. It protects the well-being of the public in the US by ensuring the safe quality of food, medical and several other commodities. US-FDA is also responsible for the imported goods that are packaged, marketed or distributed in the nation.
What Does FDA Regulate?
Below is a category wise list of products that the FDA regulates –
- Food – This category includes bottled water, infant formula, dietary supplements, food additives, etc. FDA is not responsible for regulating meat and poultry products. The US Department of Agriculture plays the lead role in these food items. FDA monitors the imported food as well as the local food-producing firms for safeguarding the health of the nation by protecting consumers from unsafe food. It is done through research and methods development, inspection, voluntary destruction, sampling, recall, seizure, injunction, and criminal prosecution.
- Drugs – This includes all over-the-counter non-prescription drugs as well as prescription drugs. Any drug should be FDA approved for the disease that it intends to cure. For example, if the FDA approves an analgesic for back pain, it cannot be used to cure stomach pain.
- Biologics – This class indicates regulation of products like blood and blood products, allergenics, tissue and tissue products, vaccines, and cellular and gene therapy products. Centre for Biologics Evaluation and Research (CBER) regulates the biologic products, pharmaceuticals derived from them, their transport and the devices used in the process. It also defines the guidelines for blood, organ and other kinds of donations.
- Medical Devices – As the name suggests, this group combines simple as well as complicated medical devices. From simple items like tongue depressors, bedpans, and dental devices to complex things like heart pacemakers and surgical implants and prosthetics. The FDA examines reports of any adverse events in case of medical devices and immediately alerts the health professionals and the public of the event. In such cases, it can even force for recall of the said device.
- Radiation Emitting Electronics Products – Stuff like microwave ovens, laser products, mercury vapor lamps, ultrasonic therapy equipment, sunlamps, and x-ray equipment are included in this group.
- Cosmetics – Major range of cosmetics are included in this category like nail polish and perfume, skin moisturizers and cleansers and color additives found in make-up and other personal care products. For the cosmetics industry, it is yet not mandatory to be FDA approved. However, an FDA approved cosmetic product definitely stands apart in the market. When found disobeying the FDA regulations, a cosmetic product can get a warning letter demanding an explanation about the same. In some severe scenarios, a cosmetic commodity might even be recalled from the market and the public is alerted about its use.
- Veterinary Products – This includes pet food, livestock feeds, and veterinary drugs and devices. The Centre for Veterinary Medicine (CVM) inspects the industry for ensuring good quality animal food, drugs, and overall animal safety and health.
- Tobacco Products – Cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco fall under this class. In addition, to regulate the tobacco content in a product and its quality, FDA also keeps a check on the tobacco distributors. Stringent rules and methods are developed to stop distributors from selling these products to minors.
Why do you need FDA Compliance?
For selling a product in the US that falls under the US-FDA regulations, the brand needs to get compliance from the FDA. Moreover, compliance means that the company has to maintain the quality of the product. The FDA is authorized to inspect the products circulated in the market to check its quality standards. If at any point, the FDA finds a producer, marketer or distributor, not obeying its regulations, it can charge them of penalties and even force them to shut down. Additionally, due to its strict regulations, the FDA forces the companies to strike a balance between maintaining the quality and push to make profits. This gives the FDA approved products a marketing edge and thus they are trusted worldwide.