Private and White Label: what they are and how they differ
Private Label and White Label are both manufacturing and branding strategies, but they have some key differences.
Guide on US health claims on drink/supplements labels
Diets low in sodium may reduce the risk of high blood pressure.
Development of cancer depends on many factors. A diet low in total fat may reduce the risk of some cancers.
Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [Name of the food] provides [xxx] gram of EPA and DHA omega-3 fatty acids.
These are just 3 examples of health claims allowed by the FDA. If your products sell on the US market, incorporating such statements into the label design of your goods can elevate their desirability.
Unlike in the EU, however, navigating this regulatory landscape is more of a chore, as you’re forced to pour over legal documents to grasp the specific requirements making the use of such claims lawful. And it’s not quite so straightforward.
In fact, the 3 examples we opened with are actually, in the sense that the FDA sees them, two separate types of statements. The first two (sodium and total fat) are considered Health Claims, while the latter is a Qualified Health Claim.
The difference is hard to grasp unless you spend time parsing the legalese in these documents, but can be roughly oversimplified to mean the following: Health Claims are supported by Significant Scientific Agreement (SSA), and their use is more straightforward. Qualified Health Claim, on the other hand, do not meet the SSA standard; the evidence is poorer, so they must be accompanied by qualifying language.
As is the case in the EU, there is another category of claims that most people consider interchangeable (but it’s not really): nutrition claims. The FDA calls these “Nutrient Content Claims”. Still more, there’s yet another category of Structure/Function claims, with an example being “calcium builds strong bones”.
As you can probably tell by now, the regulatory landscape in the US is quite nuanced and complicated. Regardless, the opportunities made possible if you do understand it, could represent a significant competitive advantage for your product.
The fruits of good science
Whether you go for what the FDA considers a Health Claim, Nutrition Claim, or Structure/Function claim, the great news is that should you follow the requirements, you’d be making statements that are based on real science.
This comes in sharp contrast to what a lot of people have been reading on the internet, which is most often unsubstantiated anecdotes or outright quackery.
Whatever your choice, you’ll need to begin somewhere, and that’s usually either of two very specific starting points:
1/ You’re an entrepreneur with a product idea, but it hasn’t yet come to fruition. You’re starting with a new product.
2/ Your supplement or beverage is already being manufactured somewhere and being sold to customers. You have an existing product.
The main difference between these starting points is fairly self-explanatory.
If you’re starting fresh, you probably should be bullish on including health statements in your label and accompanying marketing.
If, however, your product is already selling, you’ll have to decide whether the cost of new labeling and updated marketing makes sense. My opinion? It absolutely does make sense.
Even if you’re sitting on a mountain of printed labels, they will run out at some point, so you can introduce the updated version at that time. If it’s not quite a mountain, and you feel strongly about this opportunity, you may choose to discard them and re-print. It’s a bit wasteful, but the decision falls on you.
Whatever your situation and choice, let’s talk about the various claims available to you in some more detail and the strict rules you have to follow.
Health Claims
The FDA defines health claims to mean “any claim made on the label or in labeling of a food, including a dietary supplement, that expressly or by implication, including “third party” references, written statements (e.g., a brand name including a term such as “heart”), symbols (e.g., a heart symbol), or vignettes, characterizes the relationship of any substance to a disease or health-related conditions.”
That’s quite the mouthful, but it can be simplified. A health claim is simply any statement on packaging or labeling that suggests a link between a substance in the product and a (hopefully) positive physiological effect on diseases and health conditions.
Now, you can submit your own health claims if they have the required evidence backing, but if you’re reading this introductory article to health claims, you’re probably in no such position. Fret not, however, for the FDA has a sort of a list of pre-approved claims you can make use of. While this list is rather short compared to its EU counterpart, and much less intuitive in the sense that you kind of have to dig for it, I do have a few examples:
1/ Adequate calcium (or calcium + vitamin D), as part of a well balanced diet, may reduce the risk of osteoporosis.
2/ Low fat diets rich in fiber-containing grain products, fruits, and vegetables may reduce the risk of some types of cancer, a disease associated with many factors.
3/ 25 grams of soy protein a day, as part of a low in saturated fat and cholesterol diet, may reduce the risk of heart disease. A serving of [name of food] supplies [xxx] grams of soy portein.
As you can see, these claims are a bit on the heavy side and may prove too burdensome to fully make use of considering the limited space available on product labels. Thankfully, this is just what the FDA considers a “Model Claim Statement”, meaning that you can remix to achieve more space-friendly messaging. Still, certain terms are required.
You can learn more about Health Claims and the FDA’s rules regarding them here.
Qualified Health Claims
As mentioned in the intro to this article, another type of allowed statements are Qualified Health Claims (QHC).
These are a bit more complicated to normal Health Claims in that more qualifying information must accompany the claim, are not as rigorously backed by science, and the FDA is a bit more touchy and requires strict adherence lest they send you notice.
It is possible to petition the FDA about the use of such a claim, but you should probably resign yourself that’ll it will take a while to get an answer back, and it may very well be negative. In the cases that the FDA does see your QHC as adequately supported by the available science, and not misleading, it may issue a Letter of Enforcement Discretion, outlining the specific claim language that should be used, and the factors which will inform whether they object to its use.
Once again, the above limits do not imply that you cannot make use of QHCs. The biggest problem with them is the complexity of language required, making these cumbersome statements difficult to practically integrate into label design. You saw an example on the top of this section, but here are a few more Qualified Health Claims you can make:
1/ For dietary supplements containing folic acids, you can claim that 0.8mg of Folic Acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form.
2/ For dietary supplements containing vitamins B6, B12, and/or folic acids, you can claim that, “as part of a well-balanced diet that is low in saturated fat and cholesterol, Folic Acid, Vitamin B6 and Vitamin B12 may reduce the risk of vascular diseases. FDA evaluated the above claim and found that, while it is known that diets low in saturated fat and cholesterol reduce the risk of heart disease and other vascular diseases, the evidence in support of the above claim is inconclusive.”
Hopefully, the more limited nature of Qualified Health Claims is quickly becoming apparent to you. They’re lengthier and therefore more cumbersome to make practical use of.
Nutrition Claims
Nutrition Content Claims are the second to last category of claims the FDA allows for.
You know what these are already: markings such as “Low Calories”, “Zero Calories”, “Low Fat”, “No added Sugar”, “Low cholesterol”, etc.
Unlike the more unwieldy Health and Qualified Health Claims, statements falling under the Nutrition Content Claims category offer short, easily understood messaging to be integrated with your label design. Because of this, the relative competitive strengths of your product can be easily communicated to customers, hopefully resulting in better sales.
As you likely surmised, nutrition claims are on-label/on-package statements that directly or by implication characterize the level of some nutrients in your food. To avoid gaming the system, there are strict requirements for the minimum/maximum amounts of these nutrients that can be part of your beverage or supplement, before you’re eligible to use such claims. This makes sense—Low Calories means different things to different people.
“Sugar Free”, for example, is only usable if your product contains less than 0.5g of sugars per RACC (Reference Amounts Customarily Consumed) per labeled serving.
“Rich in”, or “Excellent Source Of” are two other popular claims on products. If you want to market your product as Rich in Protein, it’ll have to contain at least 20% of the DV (Daily Value).
Final example: “High Potency”. This claim may be used to describe individual vitamins or minerals that are present at 100% or more of the RDI (Recommended Daily Intake).
To learn more about the specific requirements (Page 72) and allowed uses (Page 87) for Nutrient Content Claims, arm yourself with patience and check out the FDA’s guideline.
Structure/Function claims
Finally, let’s talk about Structure/Function claims.
These form a specific category of FDA-allowed claims on foods and dietary supplements. They allow you to describe the role of a nutrient or dietary ingredient intended to affect the normal structure of function of the human body.
Said otherwise, they allow you claim how your product helps to support or maintain the normal structure/function of the body. This makes them very similar in nature to EU Health Claims, as outlined here.
Just like Nutrient Content Claims, Structure/Function claims are a category of much more practically usable statements that can help drive sales. Examples include the following, but the list is quite long.
1/ Calcium helps build strong bones
2/ Fiber maintains bowel regularity
3/ Vitamin C supports a healthy immune system
4/ Protein helps build and repair muscle tissue
5/ Omega-3 fatty acids support heart health
6/ Vitamin A promotes healthy vision
7/ Antioxidants help protect cells from oxidative stress
As you can see, the opportunities with Structure/Function claims is quite significant, allowing you to pinpoint attention to the specific benefits your product offers. This is quite valuable, as the vast majority of consumers should not be expected to have these links (e.g., Vitamin A > Vision) memorized.
In fact, this is why I often advise our private label clients to refer to vitamins by their colloquial names. That is, instead of saying your product contains Riboflavin, which is alien sounding to the vast majority of people, you should use Vitamin B2.
You may be required to notify the FDA (can be done electronically) of products you intend to market on the US market (or already are, within 30 days of release), depending on the nature of the claims, and whether they fall within the conventional foods or dietary supplements categories.
You can read up on Structure/Function claims on the FDA site here.
Conclusion
Parsing legislature and regulatory frameworks is nobody’s definition of a “fun time”. Dealing with the FDA’s arcane website to locate specific guidance on health claims permissible on beverages/supplements sold on the US market, however, is an absolutely miserable task.
For whatever reason, a unified, searchable register for claims is not yet available, and at least to my knowledge, it’s not even on the agenda.
I don’t make the above comments lightly. AMATA Ltd. does distribute private label products to the US, and we are FDA-registered, so I have had to deal with this headache personally in the near past.
That is why I am more reserved with giving concrete advise and caution our clients about this complexity—I am well-acquainted with EU regulations, but less so with the FDA’s. Thankfully, we do partner with a US-based company specialized in compliance, and so I can point you in the right direction should you choose to work with us.
These disclaimers aside, my intention was always more to inform on the opportunity that health claims—whether nutritional, qualified, or structure/function—present to savvy marketers. As I state in the EU version of this article, I consider these to be among the few remaining low-hanging fruits when it comes to differentiating your product from the competition.
You should reach out and grab them.
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