In the United States, getting a license to sell supplements isn’t necessary, but navigating the dynamics of this can be tricky. Why don’t you, as the banded manufacturer (also referred to as Own Label Distributor), need a license to sell supplements? In this article, we’ll explain why and provide an overview of certain kinds of optional licensing or certifications that may be a good idea to obtain.
Selling Supplements Online
Selling supplements as a brand online in the United States is regulated by the FDA and FTC under the Dietary Supplement Health Education Act (DSHEA) of 1994. There are no specific requirements to become a supplement seller; however, it is recommended that your company/brand name be trademarked and the company be incorporated for taxation and liability purposes. Deciding whether or not you want to incorporate your company is up to you, and we recommend discussing this with a business lawyer before making that decision. If you choose to do so, the process is simple and can be done in your state. If you intend to identify your business with your social security number, you must get an EIN. You can get it from the government; however, you must be incorporated first.
Why Don’t You Need a License to Sell Supplements?
Whether you’re selling your supplements online or in a small physical store, a license is not required. Supplement sellers don’t have to have FDA approval to set up a shop, but they do have to be aware of the federal agency’s regulations to avoid making mistakes. For example, as a supplement seller to consumers, the FDA must register your contract manufacturer, and you must follow proper practices to ensure that quality compliance is being followed for consumer safety purposes. Essentially, partnering with the right FDA-registered contract manufacturer is a critical factor that allows you to ensure you are following regulations. The right contract manufacturer will be able to provide some suggestions on whether or not products that you intend to make are acceptable to be sold as dietary supplements.
Do You Need FDA Approval to Sell Supplements?
There is a common misconception when it comes to dietary supplements that causes reporters to claim that the dietary supplement industry is unregulated. No, you do not need FDA approval to sell supplements, but supplements are still regulated by the FDA. When people hear that, they consider dietary supplements to be the “Wild, wild west”. Under DSHEA, dietary supplements are regulated as a category of food. The FDA regulates both finished dietary supplement products and dietary ingredients. By law, it is illegal to manufacture or market dietary supplement products that are adulterated or misbranded, and the FDA has regulatory authority to remove such products from the marketplace. The FDA is concerned about ensuring manufacturers are not producing dangerous or defective ingredients. It’s important to know that the manufacturers need not be FDA-approved–just the substances they use need to be accepted dietary ingredients under DSHEA 1994, or there needs to be an accepted “New Dietary Ingredient” registration by the FDA since 1994. Again, this is a part that your contract manufacturer needs to be aware of and in compliance with.
Regulatory Standards
Choosing approved dietary ingredients within the acceptable limits is one measure you should take to stay in compliance with relevant FDA regulations. Educate yourself on how to identify supplement manufacturers that spend time following the guidelines. You’ll notice that the best contract manufacturers choose to be third-party certified by organizations like NSF to annually verify that they are following good manufacturing practices (GMPs). A branded manufacturer that is outsourcing their product to a contract manufacturer can also register their products with a certifier like NSF, but the contract manufacturer must be certified by NSF to be able to do this.
What is Good Manufacturing Practice (GMP) Certification?
The GMP Certification ensures products are consistently produced and controlled according to quality standards. It’s designed to minimize risks involved in nutraceutical production that cannot be eliminated by testing the final product. GMP is required for nutraceutical manufacturers, but it covers food and beverage, cosmetics, and dietary supplements. Choosing the right GMP manufacturer is a critical piece in your brand launch playbook, so we developed a guide to help you navigate through that process – 7 QUESTIONS TO ASK A CONTRACT MANUFACTURER.
How Paragon Laboratories Can Help
We build quality into every nutritional product we manufacture using over 200 standard operating procedures, many of which have been developed over our 50+ year history. Our highly experienced staff of chemists, biologists, and microbiologists conducts ongoing tests to ensure potency, purity, and consistency for your nutritional supplements and vitamin products. The bottom line is that at Paragon, we leave nothing to chance.
What we specialize in manufacturing:
Tablets Manufacturing
Shapes, sizes, coatings—we offer almost unlimited choices. Our state-of-the-art technology gives your product the edge for the highest quality and on-time delivery. Whether you order our minimum quantity or somewhere in the millions, our exceptional relationship with our raw material suppliers allows us to acquire the best ingredients for your tablets. Choose from:
- Enteric-coated formulations
- Color-coated formulations
- Quick-release type formulas
- Multiple sizes for various tablet weights
- Chewable tablets
- Flavored tablets
- Flavor-coated tablets
- Gum tablets
- Effervescent tablets
- Formulas that contain amino acids
Capsules Manufacturing
Regarding product development, quality needs to be in your capsules from ideation to finished product creation. Our high-speed encapsulation equipment allows us to provide our partners with the most up-to-date encapsulation processes, ensuring the highest degree of formula potency, quality, uniformity, and timely delivery of every order. Choose from:
- Variety of colors
- Vegetarian capsules
- Gelatin capsules
- Delayed-release capsules
- Plant caps
- Kosher capsules
- Enteric-coated
- Quick dissolve
Powder Manufacturing
Getting the right formulations to provide free-flowing powders of uniform particle sizing, proper solubility, and taste is a science and art built on years of experience. We have the proper equipment for temperature- and humidity-monitored production and packaging areas, as well as superb raw materials to make the highest quality powder supplements. Powders can be manufactured and packed in various packages, including bags, jars, and pouches.
Choose from:
- Herbal blends
- Protein powders
- Energy drinks
- Bulk powders
- Smoothies
- Green drink mixes
- Flavored vitamin & mineral blends
We would be delighted to work with you to develop a quotation for your particular product needs. Please note that we do have minimum order quantity requirements:
- 300,000 tablets or capsules per production run;
- 3,000 jars of powder per production run (except 10,000 jars minimum for protein powders).
Fill out the form and contact us today!