FDA Regulations to Consider as You Create Your Own Supplement


More than 150 million Americans are taking dietary supplements each year. Because of the heightened demand for health-based products, customers need reassurance that the vitamins and supplements they’re taking are properly regulated.

Dietary supplements are subject to comprehensive FDA regulations to ensure safety and quality. The law defines “dietary supplements” as products taken by mouth that contain a dietary ingredient intended to supplement the diet.

Don’t let this fool you, though. Dietary supplements include vitamins, minerals, botanicals, amino acids, enzymes, probiotics and metabolites. They aren’t limited to pills and capsules either.

Due to the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplements can take the shape of extracts, concentrate and other forms as well.

In 2007, the FDA established the Current Good Manufacturing Practice Regulations. These by-laws require manufacturers to evaluate their products through testing, purity, strength and composition.

Today, we’ll be highlighting key rules you need to know as you create your own supplement.


How the Process Works

Entrepreneurs are often surprised to learn that dietary supplements fall under the FDA’s line of scope. People often confuse dietary supplements with prescription or over-the-counter medicine and expect them to be regulated in the same way.

However, according to DSHEA, supplements are viewed as a subset of foods – and so, they are regulated as such.

Just like the food you see stocked on the shelves of a grocery market, the FDA regulates the types of ingredients allowed in supplements and the claims that can be made about them.

The FDA also requires detailed nutrition and allergen labeling along with identity and net quantity statements.


Key Regulations You Should Know

Whether this is your first time to create your own supplement (or your fourth), you should know the following regulations if you’re considering developing and marketing a dietary supplement:

Every dietary supplement must be labeled as such, either with the term “dietary supplement” or a term that substitutes a description of the product’s ingredients like “calcium supplement.”

The law doesn’t require dietary supplements to be proven safe to the FDA’s satisfaction before they’re marked. However, proceed with caution in this area. Read more here.

The FDA’s role with a dietary supplement begins after the product enters the marketplace. From there, the FDA may take action against a product that presents an unreasonable risk of illness or injury.

Supplement advertising, including TV and radio ads, falls under the jurisdiction of the Federal Trade Commission.

As its resources permit, the FDA reviews products labels and other product information such as package inserts, accompanying directions and online promotions.

Dietary supplements must report any serious adverse events to the FDA that are reported to them by consumer or health care professionals.

Dietary supplement manufacturers do not have to get the agency’s approval before producing or selling products. This is one of many reasons why it’s better to work with a seasoned manufacturer who specializes in the supplement industry.


The Types of Claims That Can Be Made

Under the law, supplement manufacturers have three categories of claims that can be used: health claims, nutrient claims and structure/function claims. Each of these must be truthful and in no way misleading.

Health Claims – describe the connection between a nutrient or food substance and reduced risk of a disease or health-related condition. The FDA can authorize a claim in one of the following ways: as an authorized health claim, authoritative statement or qualified health claim.

Nutrient Content Claims – describe the level of a nutrient in a dietary or food supplement. Percentage claims are used to describe a level of ingredient for which there is no established Daily Value.

Structure/Function Claims – are statements that describe the role of a supplement intended to affect the structure of function of the body, the mechanism of how it helps maintain that structure or general well-being.


In summary, the FDA regulates dietary supplements under a different set of regulations than those covering conventional foods and drug products. Under the law, manufacturers and distributors are prohibited from marketing products that are misbranded.

These firms are responsible for evaluating the safety and labeling of their products before taking to market. To learn more about DSHEA and FDA regulations, please visit the official website here.

For more information about Ameri-Kal’s private and custom label supplements, reach out to our team today at (405) 225-1804. We’re happy to answer any questions you may have about product development, testing and distribution!


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