It generally isn’t necessary to get any kind of licensing to sell supplements in the United States. As a reseller of pre-made supplement products, you aren’t the focus of attention of the FDA and other relevant regulatory organizations — rather, the original manufacturer is the one that must be registered with the FDA and follow all their other guidelines.
Over the course of this guide, we’ll explain why licensing isn’t necessary to become a supplement seller. We’ll also explain, though, why certain kinds of optional licensing or certification might be a good idea. Prepare to learn everything you need to know to start selling supplements safely and legally.
What You Need to Know About Selling Supplements Online
For the most part, selling supplements online is a loosely regulated industry, and there aren’t any particular requirements to become a supplement seller in the United States. It’s usually a good idea to officially incorporate your company for taxation and other reasons, and you’ll also want to secure an EIN number so that your company isn’t just tied to your person — especially if you want to employ others.
The US Food and Drug Administration (FDA) is the main regulatory agency supplement manufacturers need to be aware of. As the online supplement industry matures, however, expect the FDA to become an increasingly friendly ally to your success.
Incorporate Your Company
There may be some reasons not to incorporate your online supplement business — it’s best to speak with a competent business lawyer before proceeding. Most supplement sellers will choose to incorporate, however, a simple process that you can get done in your home state. There might be some other states where you can incorporate as well that offer incentives for companies setting up shop.
Get an EIN Number
Unless you intend to identify your business solely with your personal social security number, you’ll need to get an EIN, a company’s version of an SSN. To get an EIN from the federal government, you usually need to be incorporated first. Being properly incorporated as a business and having an EIN are all that’s necessary to sell supplements online, though.
Do You Need a License to Sell Supplements?
No special licensing is required in the United States to sell supplements, either online or in a brick-and-mortar store. It’s generally wise to be incorporated as a business and have an EIN first, but after that point, you’re good to go. Supplement sellers do not need FDA approval to set up shop, but they should be aware of the federal agency’s many regulations to avoid making beginner mistakes.
Is FDA Approval Required for Selling Supplements?
No, you do not need the FDA’s approval to sell supplements. The FDA’s main job in the supplement industry is to make sure manufacturers are not producing dangerous or defective ingredients. Once those ingredients have been approved, it’s understood that products made using them will also offer a similar degree of safety.
Even supplement manufacturers do not need “FDA approval.” The FDA only “approves” substances, not businesses. Manufacturers may seek FDA registration, however, a process that proactively informs this federal agency that you intend to follow its guidelines.
Key Regulatory Standards
As an online supplement seller, choosing good sources of ingredients is the main measure you should take to stay ahead of any relevant FDA regulations. To do so, you’ll need to learn how to identify supplement manufacturers that take the time necessary to follow these complicated guidelines.
It’s usually a good sign that a company also follows the FDA’s instructions to a “T” when they are proactively certified by optional organizations, such as ISO and GMP. Learn more about these two prestigious forms of certification below:
What is Good Manufacturing Practice (GMP) Certification?
GMP certification is offered to companies that can demonstrate that they follow internationally agreed-upon Good Manufacturing Practices, which generally encompass a business ideology that prioritizes safety, fairness, and transparency. Only companies that conduct their business in environmentally friendly and ethical ways are eligible for GMP certification.
What is ISO Certification?
ISO is a certification provider that focuses more on technical standards than it does on environmental and ethical stewardship. Achieving ISO certification is a sure sign that your manufacturing laboratory is up to standard and incorporates all the latest technological innovations. To be clear, ISO and GMP are independent organizations that are not part of the US government.
Manufacturing Considerations for Different Supplement Types
The online supplement market is largely divided into three segments: gummies, capsules, and softgels (also known as gelcaps). The best manufacturers can provide all three, but every supplement type has a different composition, requiring specialized knowledge of each. Taking a look at each option in more detail is a great place to begin:
Gummies
When finding an ideal company for gummy manufacturing, seek out fully certified companies that use trending ingredients like cane sugar and tapioca syrup. The old perception that dangerous or artificial ingredients are acceptable in gummies has largely disappeared, and ethical manufacturers wholeheartedly embrace the shift gummies have taken toward becoming more healthy.
Capsules
Capsules are largely the same as they always have been — simplicity is the key here. Ethical capsule manufacturers are shifting away from filler ingredients and toxic additives, preferring to keep their capsule formulas simple and to-the-point. Proper certification also applies here, and you’ll want to prefer capsule manufacturing companies that use excellent ingredients in their other products, too.
Softgels
Softgel manufacturing has undergone a revolution in recent years, ditching animal products and focusing on vegan alternatives. Some customers still strongly prefer softgels, which contain an oil rather than a powdered base. It’s a plus if a softgel manufacturer uses MCT oil, a highly versatile yet fully natural substance that has plenty of impressive benefits.
Benefits of Working with a Contract Manufacturer
Given how tightly the FDA regulates dietary supplements, the average entrepreneur simply doesn’t have time to make their own supplements. It’s possible to run a supplement-selling company, however, just as a single person, opening up your possibilities and reducing your responsibilities.
The key here is finding the right contract manufacturer, a company that can make the supplements you need while also navigating the labyrinthine complexity of the US federal bureaucracy. TrustWorks is the leading supplement manufacturer in the United States — it’s our job to concern ourselves with FDA compliance so you don’t have to. Simplify your rise to the top of the online supplement market by working with TrustWorks.
Frequently Asked Questions
Do you need FDA approval to sell supplements?
You do not need FDA approval to sell nutritional supplements in the United States. The ingredients in your products should, however, comply with FDA guidelines. Otherwise, they may face removal, and your company could come under FDA scrutiny.
What types of supplements require licensing?
Generally, the only time you require special licensing to sell supplements is if they contain substances classified as drugs under the Controlled Substances Act (CSA). There may also be other reasons to properly license supplements, which is why it’s advantageous to work with a white labeler that has already cleared all these regulatory hurdles.
Are there specific licenses for gummies, capsules, and softgels?
No, the three supplement categories of gummies, capsules, and softgels do not require any special forms of licensing. No licensing is required for any supplements, in fact, under the vast majority of circumstances. Regardless of the type of supplement you intend to sell, understand that licensing is generally not required under US federal law.
Do I need a contract manufacturer to meet compliance requirements?
While working with a contract manufacturer is not strictly necessary to stay in compliance with state and federal regulations, having a trusted company make your supplements for you is certainly a wise move from a regulatory perspective. Otherwise, you’ll need to navigate the FDA’s complex framework yourself, an onerous burden for any entrepreneur just starting out.
Can I manufacture supplements at home and sell them?
It is definitely not advisable to attempt to manufacture safe and marketable supplements inside your own home. The average home is not equipped with the proper facilities for supplement production, and it is also very difficult to register a residential address as an FDA-approved facility.
Any supplements you’re able to make will be sub-par in quality and likely contaminated. It’s a much better idea to source your supplements from a reliable supplier like TrustWorks.
Conclusion: Work with TrustWorks
To start a successful supplement brand in today’s market, it’s no longer necessary to be an expert on the dietary supplement industry or which health supplements are FDA-approved and which aren’t. From herbal supplements to dietary supplement products of the more conventional variety, working with a private labeler is truly the most effective and obstacle-free path to long-term and sustainable success.
Online supplement sales continue to grow over time, and there’s no sign of any slowdown. Americans are taking their health more seriously than ever before, so you should fully expect a coming boom in natural health and supplements. Selling dietary supplements online has never been a better business move, and it’s now easier to sell supplements online than ever before.
When you private label supplements, you do away with worrying about FDA regulations, allowing you to focus on reaching the right audience with high-quality supplements designed to fill a particular niche. Leave quality control, health claims, and the rest of the headaches to the experts — liberate yourself to achieve utter success in the supplement market by working with TrustWorks.
