In an industry where the customer is quite literally a consumer, supplements are increasingly drawing the attention of entrepreneurs, buyers, and the Food and Drug Administration (FDA). Having drastically increased in popularity over the past three decades (and projected to grow nearly 10% every year), supplement fulfillment is projected to be a $278 billion industry by 2028.
With the booming nature of selling supplements online, it’s important for business owners to pay special attention to the rules and regulations of the industry and also provide an excellent customer experience. We’ll explore all of this below and touch on the importance of partnering with a team that knows the industry’s requirements inside and out.
Succeeding as a Supplement Company
With all of the moving pieces that accompany supplement fulfillment, it can be easy for companies to fail to adhere to the regulations of the industry. In large part, this is because the regulatory information can feel daunting to tackle.
As the industry grows, companies large and small are going to draw the attention of regulatory entities, so it’s essential to take the information below to heart. While following the step-by-step process to sell supplements online may seem tedious to start, the pay-off is worth it.
With that housekeeping out of the way, let’s take a look at the unique world of online supplement fulfillment.
Selling Supplements Online
Shipping supplements is somewhat unique in the world of e-commerce. A major reason for this is the amount of products with limited testing emerging in the space.
While this industry’s growth is drawing more attention from the FDA (and there are plenty of regulations to adhere to), there’s still plenty of room for improved regulation. In fact, tainted supplements are cited as sending thousands of people to the emergency room each year.
All of this means your role as a business owner selling supplements is becoming more important, both for your customers’ safety and well-being and for your business’s longevity and integrity.
Supplement Regulations & Requirements
Mixing business and health can come with its fair share of problems. It’s important to understand the industry’s regulations and requirements before really diving in, and this includes understanding what a supplement is:
Supplements are defined as products intended to supplement the normal diet and they’re broken up into several categories:
- Vitamin
- Mineral
- Herb or botanical
- Amino acid
- Dietary supplement (meant to supplement the normal dietary intake)
- Extract or concentrate comprised of any combination of the categories above
Everything from fish oil to fat-burning pills falls under this category, so it’s important to pay special attention to the regulations pertaining to the supplement(s) you are selling. Ensuring the products you are selling are properly labeled is FDA required. From there, working to make sure you’re providing quality products that are safe and effective for your customer is a matter of integrity and transparency.
Supplements, Regulations, & the FDA
It’s important to remember that just because a supplement isn’t FDA approved yet doesn’t mean you can’t ship it or that it’s inherently bad. For instance, if a product contains a new ingredient, the manufacturer must notify the FDA, and the product will be reviewed (not approved) for safety but not effectiveness. The reason for the differentiation between review and approval was created to keep both the customer’s safety and the company’s ability to sell in mind from the outset.
If the ingredients in the dietary supplement have been on the market already, the manufacturer does not need to supply evidence to substantiate their claim of safety or effectiveness. As a business owner selling supplements, your best bet is to offer products you believe in that have, at the very least, been deemed safe by the FDA.
Registration
While there’s plenty of freedom in the United States for businesses to sell online, it’s still important (and necessary) to make sure you’re conducting your supplement business responsibly.
Under the FDA’s Bioterrorism Act, manufacturers of supplements must register their entity before creating or selling supplements. The FDA published a detailed list of these regulations in June 2007. These regulations are in place to secure the following information about a supplement:
- Identity
- Purity
- Quality
- Strength
- Composition
The above list is also an important reminder to find a fulfillment partner that’s registered to ship supplements, as it pertains to any entity that manufactures, packages, or holds supplements.
Labeling
When shipping dietary supplements, five items must be included on the label:
- The statement of identity
- The net amount of the dietary supplement
- The nutrition labeling
- The ingredient list
- The name and location of the manufacturer, packer, or distributor
When it comes to labeling, it’s not just what you put on the label, but where you put the information on the container. All label requirements must be placed on either the front label or on the information panel. Usually, this is the label panel immediately to the right of the primary display panel.
We recommend exploring the Dietary Supplement Labeling Guide created by the FDA for a full rundown of labeling requirements.
Good Manufacturing Practices
One area of the supplement industry in particular that is highly regulated is the manufacturing process. The FDA’s Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (known as the Dietary Supplement CGMP Rule) requires manufacturers of supplements to follow specific procedures and recordkeeping to ensure compliance with regulatory requirements.
Known as a written master manufacturing record (MMR), the FDA requires MMRs to outline the following:
- Identifying information for the supplement, including properties such as concentration or strength of each ingredient for each batch size.
- Specifications for points in the manufacturing process that require controls to ensure the quality of the supplement.
- Specific actions needed to implement and verify these controls.
- Corrective actions when specifications are not met.
What Is a Dietary Supplement?
Dietary supplements aren’t limited to just diet pills, since multivitamins fall under this umbrella term as well. Supplements are a combination of vitamins or minerals that enhance a standard diet. Typically, they help a person get adequate amounts of essential nutrients and are more than just vitamins. Herbs, botanicals, amino acids, and enzymes may also be considered supplements.
The important thing to remember is that supplements and pharmaceuticals operate in entirely different spaces and shipping the two is an entirely different ballgame. Supplements are actually regulated as “food” by the FDA, not drugs. Unless you’re an authorized dispenser or registered agent of a drug manufacturer, shipping medical products is strictly prohibited.
If you happen to be a business that sells both supplements and pharmaceuticals, keeping all of your fulfillment in one place is likely best. For this, you’ll want to find a 3PL that is proficient and licensed in supplements, nutraceuticals, and medical kitting.
What to Look for in Supplement Fulfillment
The importance of finding a qualified 3PL is crucial no matter what industry you find yourself in. But when it comes to supplement fulfillment, it’s crucial to partner with someone that is FDA registered.
FDA Certified & cGMP
Making sure you — and the 3PL your partner with — are cGMP compliant is important. However, this isn’t the only thing that matters, as the FDA also requires the 3PL providing supplement fulfillment to be FDA Certified.
Along with having the necessary certifications, there are a few questions to ask the 3PL you’re evaluating to determine whether their facilities and procedures are up to par:
- Does the 3PL use a quality management system?
- Do they perform regular audits of their processes and warehouse optimization?
- How does their system handle product returns or recalls?
Before partnering with a 3PL for supplement fulfillment, it’s important to know how they match up in this highly regulated industry. Failure to do so can result in costly fines, customer dissatisfaction, and your company’s integrity taking a huge hit.
Handling of Materials
Another important factor to consider when looking to partner with a 3PL for supplement fulfillment is how they handle the products. Storing, picking, packing, and shipping are all vitally important to (1) ensure proper safety and health standards are being met and (2) the correct products are arriving at your customer’s door.
Supplement Fulfillment FAQs
Can I Ship Supplements Internationally?
Yes, you can. As long as all supplements adhere to FDA-approved labeling regulations and requirements, you shouldn’t run into any trouble.
It’s important to remember that different countries have different regulations in place when it comes to how they handle the supplements industry. Working with international markets means checking the product compliance of the country you intend to ship to, as different countries may have different rules regarding imported products, customs, and sanitation.
Do I Need a License to Sell Supplements?
You do not need any special license to sell supplements online. Simply adhering to FDA regulations and finding a 3PL that is FDA certified (if you are looking to outsource supplement fulfillment) will suffice.
If you plan to create and manufacture your supplements, you need to obtain your own certifications and acquire additional insurance. We recommend getting in touch with a business attorney for this.
The most important element to get right is labeling. Ensuring your supplements (and therefore your business) don’t get bombarded by violations is the most surefire way to preserve your integrity and products.
Is it Illegal to Sell Supplements Online?
It’s not illegal to sell supplements online. However, failing to adhere to FDA standards can earn you more than a slap on the wrist. You also need to make sure the supplements you’re selling don’t contain any illegal/banned dietary ingredients.
Mistakes aren’t just made by small online businesses, as major business entities often fail to adhere to FDA regulations as well. But the cost of ignoring the necessary regulations is far greater than the cost of some returns and a few disgruntled customers, it could cost you your reputation and your business.
Finding a 3PL that is FDA certified and knowledgeable in supplement fulfillment can be difficult. We’re here to make it easier. If you’re looking to enhance your shipping process by partnering with a 3PL that understands shipping and supplements, feel free to contact us.
