Creating a Stunning Compliant Dietary Supplement Label

Great packaging is essential, it’s your customers’ first direct experience with you, it goes a considerable way to making up your customer's mind about your product and you.

YouTube is filled with unboxing events. Therefore despite selling a supplement online, premium products require everything to have an air of quality to them.

If you’re planning on selling a supplement in the USA your supplement labels need to be fully compliant with the FDA. Otherwise, you run the risk of falling foul to a hefty lawsuit which will inevitably lead to being forced to close up shop.

I’ve said this before and I will say it again, not all supplements are created equal.

With all the above in mind, it’s essential to provide as much information to the consumer as possible, as well as be immediately clear what the supplement will do for them.

This article also covers the legal requirements and ensuring your dietary supplement label is compliant. The first step though is designed and producing your supplement label.

How to Choose a Supplement Label Designer

It’s quite possible your manufacturer will provide a label designing service, if you are happy with this you just need to supply the necessary information to them. My supplement manufacturer does provide this service, but I decided to do this myself.

There is a very good reason for this, the manufacturer has their own label formats, but my supplement is a premium product, it’s special and needs to stand from the crowd.

Full disclosure here, when I say “I decided to do this myself”, I really mean I posted the job on the freelance website UpWork and spent a few hours looking for talented packaging designers. From the six or so designers that I liked the look of their work, I selected two packaging label designers to work independently on my supplement label.

You may remember when I used a service called 99Designs to create my supplement logo. I did consider choosing them for my supplement label but felt the cost of choosing “top-level designers” was very high and hoped I would get better value for the money with packaging designers on Upwork, in the end, it turned out to be 1/2 the price!

I prefer this approach because it enabled me to get a faster turnaround time and allowed me to work with the designers in the future on other projects should I wish.

So, why did I select two designers and not just one?

For three reasons, firstly I wanted to have more design choices and secondly, two different designers would have different approaches to the same task. Thirdly, I have been on the lookout for a “go-to” packaging designer for projects in the future. So in effect, I was interviewing them to see who could do the best job, the only difference here, being they were both paid

A quick tip here, I would recommend selecting a designer with experience designing packaging and labels instead of a general graphic designer.

Whilst they may well be more than qualified to create a visually stunning supplement label, there are specific guidelines needed for creating packaging, which may get missed. In the same way, as there is also a difference when it comes to designing for print versus designing for the web.

Know Your Supplement Label Size

First off you need to know exactly what your label size is, so your supplement label designer then has the measurements to work from.

The tub I am using for my Super Greens is a 32-ounce HDPE tub, which works out to be a label size of 11.12 inches by 5 inches. This site is because I need enough space to contain 30 scoops of 12g servings (360mg).

My supplement manufacturer gave me the exact label size and supplied a template to use when designing the label. You can see the template below:

What to Put on Your Supplement Label

So, what makes up the elements for a dietary supplement label?

It goes without saying that you should have a strong brand identity that is reinforced through your logo and company. Other important information include your company name and address.

It makes sense to put the country of manufacturer too, especially if “made in the USA” as this gives confidence in the product if selling outside the US and traditionally people in the US like to buy “Made in the USA”.

Practical advice on the recommended dosage and serving size is also important, along with any warnings for the consumers.

Of course, there should be a complete list of the ingredients in the supplement, which are presented in a particular order and format. I explain the requirements a little later on – see Supplement Facts below.

Supplement Benefits and Claims *

When stating health claims, you MUST to be very careful you don’t fall foul of the FDA.

Label claims fall into three categories; health claims, nutrient content claims, and structure/function claim.

The easiest one to deal with first is the “Nutrient content claims” as this is basically the supplement facts stated on the label. Your manufacturer or third-party testing company will provide these details, so this is unlikely to be an issue.

You should take the greatest care with any health and structure/functional claims you make.

Health claims are those that state the relationship between an ingredient and a reduced risk of a disease or health-related condition. This is a big no-no, especially for over-the-counter dietary supplements as these aren’t pharmaceutical medicines and not be evaluated by the FDA.

In short, it’s best to avoid making ANY health claims.

The last category of “structure/functional claims” is directed at claims of well-being and relating to nutrient deficiency diseases.

manufacturer must have substantiation that the claim is truthful and not misleading and must submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement with the claim. FDA website

Importantly, you cannot make any claims that your supplement can “diagnose, treat, cure or prevent any disease,” because only a drug can legally make such a claim.

The definition may seem relatively straightforward, but the line can be blurry especially when improperly phrased or inadequately supported claims as highlighted by David Torreblanca.

To avoid any legal issues or otherwise, my label will not make any health claims on the label and instead use icons that indicate the potential ingredient benefits.

Barcode on the Label

Whilst having a barcode on the label isn’t a legal requirement, it is probably a good idea to do this from the start.Because, if you ever decide to sell on Amazon or go the Wholesale route then a barcode is a requirement for tracking purposes.

I have never looked at how to get a unique barcode for a product but found an incredibly useful post on the CPCStrategy website.

There is also a great tutorial on buying barcodes on the Nationwidebarcode.com website

When first applying for a barcode on the GS1 website I did stumble upon my first hurdle, my company isn’t registered in the USA, so I was unable to apply on this site and was asked to visit another certified partner. Doing this meant I needed to register with the partner and wait for them to get back to me.

It turns out that the membership for GS1 in my country is not cheap at around $1,000 USD and then $500 per annum.

Looking into this further I found there are two ways of getting a barcode, the cost of using GS1 is so that you can have the luxury of having your own Company Prefix on the barcode.

I just need a valid bar code at this point, and whilst I believe my supplement brand will do well, adding another $1000 to my investment for this luxury didn’t seem wise. I can always have my own company prefix via GS1 later on for instance when I re-order my next batch.

Therefore, I decided to purchase a cheaper barcode from Cheap-UPC-Barcode.com for the time being. This cost me under $20 I can have 10 barcodes and have one on the label. The only difference is I get their company prefix, this I see as an expensive vanity purchase for later.

After the purchase I received the barcode images I then passed them onto both my label designers.

Supplement Facts and Nutrition Information

As I said earlier, one of the biggest legal requirements for a dietary supplement label is ensuring you have accurate supplement facts that are presented exactly to FDA requirements.

There are a number of guidelines listed on the FDA website concerning the supplement fact requirements. However, the easiest solution is to get your manufacturer to produce the supplement facts, this way you can be sure they are compliant.

Source: https://www.nutrasciencelabs.com/blog/tips-for-creating-an-fda-compliant-supplement-label-infographic

Using Industry Seals and Logos on your label

You can get in trouble for using some industry seals and logos on your label and so it’s best to avoid doing this. For example, the FDA logo can only be used by the United States Food and Drug Administration.

Another example is the GMP logo, which is a set of guidelines for manufacturing products. Although you can’t use the logo, you can say that your product was “manufactured in a cGMP facility”.

This is because GMP-certification is given to the facility in which your products were manufactured, rather than the products themselves.

NLEA Testing

I asked the manufacturer if they can provide the nutrition breakdown for each serving of my supplement. This is not something they can do in-house, so they suggested that I look at having NLEA testing.

This has implications for the production schedule as finalizing my label can only happen after testing, which means a possible 2-3 week delay. Not ideal but I believe NLEA testing is essential, here is why.

What is NLEA Testing?

Nutrition Labeling and Education Act (NLEA) is the requirement set out by the FDA for nutrition labeling.

Whilst I am not legally required to put the composition of fats, carbs, and protein in my Super Greens, I would like to know and believe many of my customers would too.

It would be great for anyone following a keto-based diet, as the number of carbs in each serving is critical if looking to keep under 20g per day! Ideally, I want my supplement to be keto-friendly and will only find out once I get the results back.

You can see an example of the information that will be on my label after getting the results from the NLEA testing:

Supplement Label Compliance

Once you have the draft of your supplement label, you can send it to your manufacturer so they can confirm if it is compliant.

I would also suggest it’s a good idea to run your label via legal counsel this will give you added reassurance. Having said this, I decided I didn’t need to do this as I wasn’t making any health claims and was confident in the feedback from the manufacturer.

The most interesting point raised was the inclusion of a full USA address or a phone number with the city, state, and zip code. I followed up on this as my company wasn't registered in the US and so needed to find a solution to this.

The manufacturer followed quoting the FDA website:

Section 403(y) of the FD&C Act (21 U.S.C. 343(y)) requires the label of a dietary supplement being marketed in the United States to include “a domestic address or domestic phone number through which the responsible person…may receive a report of a serious adverse event with such dietary supplement.” If the label does not include the required domestic address or phone number, the dietary supplement is misbranded.

So, I will need to have a USA address on the label it seems to be fully compliant. More on this later as I get back to solutions for this in another post.

I sent the required updates to my label designers and they made the changes.

Finalising the Supplement Label

Once the label was signed off by my manufacturer I need to wait until the product has finished products so that it could be sent for NLEA testing.

When I have the NLEA test results back, the manufacturer can update the “Supplement facts” section with the carb/fat and protein content. The labels can then be printed and applied to the tubs and then they will be ready to ship to the fulfillment center!

This is all I can do with the supplement label for the time being until the product is ready. The next step is forging ahead with the website.