FDA License for Supplement Sales | Soft Gel Technologies

Before You Get Started

The best way to build your brand and grow a loyal customer base is to provide high-quality and authentic products. Reliable and dependable products help distinguish your brand from others and allow for the kind of success that small business owners dream about.

That’s why working with an established manufacturer is better than creating your supplements yourself. A contractor has done the heavy lifting. They’ve followed the United States Food and Drug Administration’s (FDA) mandates and GMPs. You can benefit from that preparation.

The FDA regulates both supplements and their ingredients. They do this under different regulations than those covering foods and drugs. The specific law that governs these regulations passed in 1994. It’s called the Dietary Supplement Health and Education Act (DSHEA), and anyone starting a supplement company should fully understand it. You can retain the help of a competent lawyer or consultant who specializes in FDA and regulatory compliance matters to provide you with strategic advice, if needed.

Additional benefits of selecting an experienced manufacturer for supplements include saving a lot of money on equipment, factories, and other infrastructure needs. Just make sure the manufacturer uses GMP-certified facilities. When manufacturers register with the FDA and follow their comprehensive regulations, you can safely guarantee your supplement’s purity, quality, and strength.

Should You Notify the FDA About a Dietary Supplement You Intend to Market and Sell?

DSHEA requires that any manufacturer or distributor notify FDA only if your supplement includes a new ingredient. Part of that notification process includes explaining to the FDA why you need to use this new ingredient and why its use is justified.

You must also provide evidence that the ingredient is reasonably safe for use in a dietary supplement. This requirement is waived if the ingredient is new to supplements but has been in the food supply.

The government has not established an official list for what counts as an “old ingredient.” As a result, it’s up to each manufacturer and distributor to determine if their ingredients are new. If it’s not new, you are responsible for documenting the details and doing the research to prove it to the FDA.

DSHEA Basics

Selling supplements to the public must be taken seriously. Although you don’t need an FDA license to operate, you are prohibited from marketing any supplement that has been “adulterated or misbranded.”

This means that you take full responsibility for the safety and labeling of your supplements. You are also guaranteeing that your products meet all FDA and DSHEA requirements.

If something goes wrong once your dietary supplement reaches the market, the FDA has full authority to take action against you.

Grandfathered Ingredients

DSHEA clearly states that dietary supplements and their ingredients are not to be regulated as food additives. They established two different categories for supplement ingredients.

One is called the “old” or “grandfathered” category. This includes all supplement ingredients used and marketed before October 15, 1994. Because they’ve been used without issue, they’re considered safe and can continue to be used.

New Ingredients

There is also the category for “new dietary ingredients.” For manufacturers to use a “new dietary ingredient,” they have to notify the FDA through a new dietary ingredient notification that argues why this ingredient is safe to use.

This must be done at least 75 days before the product goes to market.

What Information Do You Include on the Dietary Supplement’s Label?

The label of a dietary supplement is important. While FDA license registration isn’t required, the FDA does regulate the information you can or must put on each label. This information includes:

A descriptive product name
Indication that the product is a “supplement”
The manufacturer’s business name and location
The packer or distributor, if different from the manufacturer
A complete list of ingredients
The product’s net content
A nutritional label listing “Supplement Facts” (unless it’s a qualifying small-volume product or your small business is exempt)