What is a Patent and what is FDA Approved?

How do you know if supplements you take are the high quality nutritional products you need? One way is to learn more about the scrutiny they’ve undergone through official screening and approval processes.

 

Plus, as you’ll see, the more you know about patents and FDA processes, the better you’ll be able to not only select high-quality supplements, but to absolutely crush your next trivia night.

 

What is a patent?

A patent is a form of intellectual property that grants protection for an invention. The U.S. Patent and Trademark Office (PTO) approves patents to protect intellectual property of an individual person or a business. 

 

“A patent is a form of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of years in exchange for publishing an enabling public disclosure of the invention.”

— The US Patent and Trademark Office (USPTO)

 

Patent holders have the right to stop others from making, using or selling an invention without their permission. Patent rights are the rights that you need to stop others from infringing on your ability to make, use, sell, offer to sell, or import your invention.

 

There are three types of patents: utility patents, design patents, and plant patents. Utility patents are for inventions, discoveries, or improvements. Design patents are for new, original, and ornamental designs for an “article of manufacture.” Plant patents have to do with literal varieties of living organisms

 

Patents can be challenging to obtain, but they last for a term of 14 to 20 years. 

 

FUN FACTS ABOUT PATENTS

If you’re a fan of trivia, you may know that the first patent was issued to Samuel Hopkins on July 31, 1790 for a process of making "potash," an ingredient used in fertilizer. The patent was signed by President George Washington, Secretary of State Thomas Jefferson, and the Attorney General at the time. The other patents the U.S. issued that first year were related to candle making and flour milling.

 

Other patents for well-known inventions include: 

  • The telephone – Alexander Graham Bell
  • The television – Philo Taylor Farnsworth
  • The car – Karl Benz (German Patent)
  • Light bulb – Joseph Swan (British Patent)
  • Incandescent lamp – Thomas Edison (US Patent)
  • World Wide Web – Tim Berners-Lee (years after the invention)
  • The iPhone – Apple 

Interestingly, when Apple applied for a patent for the iPhone, filed the patent under the simple title, “electronic device.”  Today, most patents are filed by companies or groups of collaborators rather than an individual inventor. IBM filed the most patents in 2019 — about 9,000.

 

Beyond the tech industry, some famous food-related patents include: 

  • a specific pasta shape
  • a stir-frying process
  • a device for cooking pancakes
  • a low-calorie chocolate.

Recipes can be patented, but they need to pass the test of being novel and non-obvious, an increasingly difficult barrier for food combinations that have existed for eons. But one not insurmountable, given patents on recipes for egg yolk substitutes and a specific crustless sandwich.  

 

In fact, all patents must pass three criteria -- that the invention be new, useful, and non-obvious (as well as statutory / subject matter eligible). 

 

WHY PATENTS MATTER

Patents are helpful to a society because they ensure technical knowledge is disclosed. Giving the exclusive rights of the invention to the patent holder for a period of time, while making the invention public, encourages competitors to seek alternative solutions, fostering further invention. 

 

Patents differ from "trade secrets,” where the inner workings or formulas are not revealed. 

What is FDA approved? 

“FDA approved” simply means that the United States Food and Drug Administration has found the benefits of a product outweigh its risks…. but the FDA doesn’t grant approval on any dietary supplements. It does, however, inspect and approve manufacturing facilities. 

 

WHAT THE FDA REVIEWS

The U.S. Food and Drug Administration (FDA) is responsible for protecting public health through product regulation and inspection. The FDA is, “responsible for protecting public health by regulating human drugs and biologics, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation."

 

FDA does not develop or test products before approving them. Instead, FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers. If FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the known risks for the intended use.” 

— Food and Drug Administration

 

So, the FDA may review the testing done by manufacturers. The FDA can also issue warnings or shut down facilities deemed unsafe.  Yet, as noted above, the FDA does not grant approval on any supplements, nutraceuticals, or bioceuticals. This is true under the authority of the Federal Food, Drug, and Cosmetic Act.

Almeda’s approach to approvals

As a research-based company, Almeda has extremely high standards for product quality and effectiveness. We always seek the highest level of approval possible. 

 

We go above and beyond the research we need to do in order to bring you the best products possible. 

ALMEDA AND THE FDA

As an FDA-recognized manufacturer, Almeda has gone to highest level that we possibly can with the FDA. Our products are proudly made at facilities in the USA that are compliant with the cGMP regulations as stipulated by the FDA. Our final product goes through several rounds of beta testing/efficacy testing before it’s released to a wider audience. 

 

Since the FDA doesn’t approve any supplement, you’ll see that, for example, Encarna’s label states, “These statements have not been evaluated by the FDA.” And our Kasvi packaging states, “This product has not been evaluated by the FDA.”

 

Nonetheless, our ingredients, made from real foods and all-natural ingredients, are organic, GMO-free, gluten-free, and vegan, will help nourish you and transfer high-quality energy to your body. 

 

ALMEDA'S PATENT-PENDING FORMULA

Formulated to support diabetics, Isle™ is a proprietary, patent-pending blend of amino acids that work together to support pancreatic health. 

 

In scientifically validated third party testing, Isle was found to facilitate the metabolism of insulin producing Islet cells and helped increase overall cell vitality.

 

OUR HOLISTIC, SUSTAINABLE APPROACH TO RESEARCH AND DEVELOPMENT (R&D)

We developed a suite of products to support the body’s whole process of cellular turnover and replenishment. Although we could have gone to market sooner with our very first experiment before 2016, our founder Stacy knew we needed a comprehensive line of products that would work together to support the body’s own natural processes.

 

We work with the world’s top research labs to bring you the best quality formulas possible, and we vet these products with the top institutions in the United States. Check out our science page to learn more about our rigorous testing, and the results we’ve seen. Of course, you should always consult with your healthcare provider before starting any dietary supplementation program.

 

The bottom line is that it’s our mission to bring you products of the highest quality, over a long timeline. We’re in this for the duration, just like you.