Nutraceutical Knowledge

Do I Need a License to Sell Supplements?

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Interested in starting your own nutritional supplement business? If so, now is a great time to get involved in this booming industry. In fact, the United States supplement industry alone comprises about $37 billion of the country's economy, and that number is only expected to increase as Americans become more conscious of their health and wellness. However, if you're wanting to start selling supplements, there's more to it than finding a manufacturer and selling haphazardly. In fact, the United States Food and Drug Administration has strict regulations regarding the sale of dietary supplement products under the Supplement Health and Education Act of 1994.

Specifically, there are regulations and laws in place governing not only the manufacture and labeling of these supplements, but sales as well. By understanding the steps you'll need to follow in order to legally sell supplements in the United States, you can begin to formulate and plan and begin selling custom or white label supplements confidently!

Decide on Your Business Structure

Start by registering your business and deciding on a business structure and sales model for your supplement business. The structure you select will determine how your sales profits are taxed by the government and what kinds of legal protections you have as well. Some options to consider include Sole Proprietorship, Partnership, LLC, and Corporation. For most people starting out in supplement sales, a Sole Proprietorship is the way to go, provided that you're essentially running the business on your own and don't have any employees. Down the road as your business grows, you may want to consider incorporating to better protect your assets.

Obtain Your Business Tax Registration

Buying or selling wholesale supplements will also require a business license and business tax registration. If you choose any business other than a Sole Proprietorship, you'll also need to obtain a Federal EIN and State Employer EIN. You will need these numbers in order to file taxes for your supplement sales business. All of this can be done through the Internal Revenue Service (IRS).

License to Sell Supplements? Depends on Your Busines Plan

Whether or not you need a license to sell supplements will vary depending on your specific business plans. If you have any plans to create your own nutritional formulas or manufacture your own supplements, then you will absolutely need to obtain licensing, additional insurance, and may also want to consult with a business attorney before you get started. After all, there is a lot of liability involved in manufacturing your own supplements.

Another option, and one that is much more favorable for those starting out in the supplement industry, is to go through a supplement manufacturer and obtain your own private label brand through them. This allows you to forego the need for licensing and a lot of the logistics that come along with it. Instead, you can rely on a reputable manufacturer that already has the licensure and resources needed to safely make, bottle, and label your line of supplements for you. By going this route, you can simply communicate to the manufacturer what types of supplements you want, as well as how you want them made (capsule form, chewable, compressed tablet, etc.). 

A supplement manufacturer will also be able to customize your supplements to suit your brand. Whether you want special coatings on each tablet, scored tablets, or even imprinted tablets, a supplement manufacturer will have the resources available to handle this for you.

Understanding Guidance and Labeling Requirements

It is also important to understand the strict regulations for bottling and labeling supplements that are currently in place by the Food and Drug Administration under the Nutritional Labeling and Education Act of 1990. Again, if you choose to go through a manufacturer for your bottling and labeling, you can ensure that you are in compliance. Otherwise, you will need to take your time becoming familiar with these requirements for your own business. 

For example, most supplement labeling will typically follow the same general layout:

  • Name of supplement
  • Brand statement (if applicable)
  • Nutritional labeling
  • Ingredients list
  • Contact information for manufacturer or distributor

There are also strict requirements in place when it comes to the size and height of the letters that are printed on your labeling for each supplement, and the printing here must be in black and white. All labels must also contain the serving size of the supplement, total calories/macros/vitamins/etc., and the percentage of daily value. All ingredients must also be listed by name, with the most prominent ingredient listed first and the least prominent listed last. In the ingredients list, any artificial flavors, natural flavors, or spices used must also be included here.

When creating a supplement label, businesses also need to be careful to avoid making any specific health claims, as doing so can open you up to legal issues later on. 

Last but not least, all new supplement labels need to be submitted for review by the FDA. This should be done "at least 75 days before delivering the supplement for interstate commerce," in order to provide ample time for any revisions that may be needed. Again, this is another situation where going through an established supplement manufacturer can save you a lot of trouble and hassle, since they will be able to handle all the labeling and bottling on your behalf.

The process of registering and licensing yourself to begin selling supplements may seem long and challenging, but so long as you're relying on an experienced manufacturer, the process is actually quite simple. From there, you can begin making profits by selling your supplements at brick-and-mortar stores as well as online. If you're serious about getting into the nutritional supplement business, now is the time to get your company registered.

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Sources: 

  1. http://www.nutraingredients-usa.com
  2. https://www.fda.gov
  3. https://www.fda.gov
  4. http://blog.quicklabel.com