What Entails An FDA Stamp Of Approval

If you’ve ever come across the term FDA Approved written on a company’s website or, say, a beauty commercial promoting a skincare product, you probably found yourself wondering what it really means.

First off, you must know what FDA is and what it does.

FDA is short for Food and Drug Administration, a government agency that was established back and in 1906 with jurisdiction in the United States. The agency primarily holds responsibility for the protection of public health by guaranteeing the safety of all those products that emit radiation and things like foods and cosmetics. Furthermore, it also aims to ensure the security and efficacy of medical devices, biological products, human drugs, and veterinary drugs.

When a new product, service, or treatment from either of the above-mentioned categories is set out to go on the market, it needs an FDA stamp of approval. These products and items are under the FDA’s regulation, which particularly has to do with safety-related concerns and events.

FDA holds the responsibility for improving and advancing public health through two important ways:

  • Speeding up innovations and processes that ensure safer, more effective, and affordable use of medical products.
  • Providing the public with science-based, accurate information will help them while consuming foods or using medical products to better their health.

FDA Stamp Of Approval

An FDA stamp of approval applies to particular products and items, but it has quite a broad scope of regulatory authority.

Take a look at the list of product categories that have been traditionally recognized by the FDA, which fall under its regulatory jurisdiction.

However, note that this isn’t a completely exhaustive list.

Foods

  • Dietary supplements
  • Food additives
  • Infant formulas
  • Bottled water
  • Other food products

Drugs

  • Prescription drugs (both generic and brand-name)
  • Non-prescription (over-the-counter) drugs

Medical Devices

  • Simple items like tongue depressors and bedpans
  • Surgical implants and prosthetics
  • Dental devices
  • Complex technologies such as heart pacemakers

Tobacco Products

  • Smokeless tobacco
  • Cigarettes
  • Roll-your-own tobacco
  • Cigarette tobacco

Biologics

  • Blood and blood products
  • Vaccines for humans
  • Tissue and tissue products
  • Cellular and gene therapy products
  • Allergenics

Electronic Products

  • Microwave ovens
  • Laser products
  • X-ray equipment
  • Ultrasonic therapy equipment
  • Sunlamps
  • Mercury vapor lamps

Cosmetics

  • Color additives used in makeup and other personal care products
  • Skin moisturizers and cleansers
  • Nail polish and perfume

Veterinary Products

  • Livestock feeds
  • Pet foods
  • Veterinary drugs and devices

What Doesn’t Need An FDA Stamp Of Approval?

Many products don’t require an FDA stamp of approval; however, they are either subject to FDA inspection or fall under the FDA’s regulations.

  • Compounded Drugs

These are tailored medications designed for individual patients, and these contain ingredients that may have been altered, mixed, or combined by a licensed pharmacist. Compounded drugs are meant to cater to specific patients according to their requirements.

  • Dietary Supplement 

When creating dietary supplements or products containing new ingredients, manufacturers must notify the FDA before they set out to market their products.

  • Food Labels

While food labels don’t need pre-approval, they must include the Nutrition Facts panel.

  • Healthcare-Related Companies

These include places like hospitals, laboratories, surgery centers, other health facilities, and manufacturers.

  • Infant Formulas

These are required to be registered with the FDA and also be compliant with federal nutrient standards.

  • Tobacco Products 

Any new tobacco products need to have a written order from the FDA which states that their product complies with FDA requirements; however, this doesn’t indicate that the particular product is approved or safe to use.

  • Cosmetics

These include moisturizers, perfumes, makeup, shampoo, soaps, hair dyes, and hair products.

Labeling Products With An FDA Stamp Of Approval

Products and items that require an FDA stamp of approval typically may include the phrase “FDA Approved” on the labeling of the product. This is done because the manufacturer has FDA approval and has received a written letter from it.

Whether a product has been approved or not, it shouldn’t use the FDA logo on its labeling. If a product’s labeling does use the FDA logo, it implies that FDA endorsed the product even when it doesn’t, which is a violation of federal law given how it’s unauthorized use of the logo. If a manufacturer still chooses to use the FDA’s logo on their product labeling, they will likely be subject to criminal or civil liability.

Another important thing to know here is whether a product requires an FDA stamp of approval or not; it still needs to comply with the FDA’s extensive labeling requirements and the FDA’s Current Good Manufacturing Practices (CGMPs). This applies to cosmetic companies, food facilities, device establishments, and drug establishments. For products that need FDA approval for sure, their labeling is approved when the product itself receives approval. However, labels don’t particularly need approval in general once the product has been approved.

Final Words

In a nutshell, some products do need FDA approval, and some don’t.

In the former case, the process of getting an FDA stamp of approval primarily depends on the type of product that you wish to market in the United States. The FDA requires not all types of products to get an approval stamp.

If you happen to be wondering how exactly FDA enforces that its requirements are being met when the market is full of so many products that do not require premarket approval. You must know that the FDA often carries out randomized shipment inspections and conducts routine facility inspections at the U.S. border through which it enforces its requirements.

Another important takeaway here is that FDA’s logo is meant for official government use only. It cannot be used to misrepresent government agency or use it in other ways to claim that the FDA has any product, service, or organization.

These are a few of the many ways through which the FDA ensures protection of and holds responsibility for public health at large.