Claims

Introduction

Claims are everywhere. Consumers can never escape them, sometimes they seek them out. Purchasing and health decisions are influenced by them every day, whether people realize it or not. As a marketer, being able to make a strong claim for a product or service that successfully targets the intended consumer audience is the ultimate goal. Without a claim, the product or service may as well never see the light of day.

This article is focused on claims related to nutritional products, specifically foods, beverages, dietary supplements, and nutritional ingredients. I spent 11 years in the nutrition industry, working for an ingredient supplier to the food, beverage, dietary supplement, infant formula, personal care, and pharmaceutical industry. At my last role I was in charge of marketing and innovation for the global Early Life Nutrition Team and responsible for launching new products and revamping existing products with appealing and provocative claims language. Claims were my life.

The nutrition industry and products produced are controlled by regulations that state what products can and cannot say on their packaging and marketing materials. These regulations place responsibility on the ingredient suppliers and consumer goods manufacturers to use claims that are complaint and backed by scientific substantiation. At the end of the day this protects the company and ultimately the consumer.

What is outside of the jurisdiction of this protection are claims made on social media by individuals, some of whom are not the ‘experts’ they claim to be. The one exception to this is if they are promoting or selling products which constitute health misinformation. It’s up to consumers to educate themselves on the things that are actually influencing their purchase decisions, seek out the real experts, make sure the real experts are who they claim to be, ask the questions to validate the information being consumed, determine where and how their hard-earned money is spent, and what can potentially affect their health for better or worse.

Background

Health claims on nutritional products are regulated by the Food and Drug Administration (FDA) with help from the Federal Trade Commission (FTC). There are three ways in which the FDA may exercise its claim oversight:

• The 1990 Nutrition Labeling and Education Act (NLEA) gave the FDA authority to regulate health claims on labels. It can do this after reviewing and evaluating the scientific evidence, either by its own initiative or in response to a health claim petition, which would be submitted by a company, individual, lawyer, consumer organization, etc.

• The Food and Drug Administration Modernization Act of 1997 (FDAMA) permitted distributors and manufacturers to use product claims if the claims were based on current, published, authoritative statements from the National Academy of Sciences and certain federal scientific bodies with official responsibility for public health protection or research related directly to human nutrition. The National Institutes of Health and the Centers for Disease Control and Prevention are considered two such agencies. A claim may be used 120 days after it has been submitted to the FDA, unless the FDA notifies the requester that their claim does not include all or enough required information.

• The FDA may review petitions for qualified health claims where the strength and quality of the scientific evidence falls below the FDA requirements to issue an authorizing claim statement. If the FDA finds that the evidence is in fact credible, and the claim can be adjusted to prevent it from misleading consumers, they may issue a letter of enforcement stating what language must accompany the claim and how it will enforce discretion for use of the claim.

The FTCs role in this is to protect the public from deceptive and unfair practices in the marketplace. Together, the FDA and FTC work to try and combat false or misleading marketing and health claims on products consumers use every day.

Based on the above, a company may petition the FDA to review claims language and the scientific evidence that supports it prior to going to market with the product. Or the FDA/FTC may be petitioned by a third party to review claims language of a product currently on the market.

There are several challenges associated with how this system is designed. One such challenge is that the responsibility is placed on the company marketing the product to comply with the regulations, and unfortunately not all companies do so. In this way they can launch products with misleading claims and reap the monetary benefits long before a complaint is filed with the FTC or FDA. This may potentially cause irreparable damage to consumer health or for consumers to waste a lot of money. More on this below, but before we get to that, let’s look at the types of claims you might see.

Types of Claims

There are several types of product claims, each with their own regulatory requirement.

Health Claims: this is the ultimate claim, the cherry on top, and what all marketers strive to achieve. These describe the relationship between a product (food, food component, or dietary supplement ingredient) and the reduced risk of disease, or health-related condition. There are several rules associated with health claims which we will not get into here. It’s important to note that the FDA maintains a distinction between ‘reducing the risk of a disease’, which is an appropriate health claim for foods and supplements if they approve it, and ‘preventing’ disease, which is legally not allowed on food/beverage/dietary supplement products as this is applicable only to approved pharmaceutical drugs. Within Health Claims there are two different types, Authorized Health Claims and Qualified Health Claims.

• Authorized Health Claim: this is a preset health claim that has already been authorized by the FDA based on “significant scientific agreement” on a subject. These claims come with very low risk of a company getting into trouble. An example of an Authorized Health Claim is “adequate calcium throughout life may reduce the risk of osteoporosis”.

• Qualified Health Claim: this is a claim that is supported by scientific evidence but doesn’t yet achieve the “significant scientific agreement” requirement. The FDA does not approve the claim per se, but will issue a Letter of Enforcement, if they decide a manufacturer may use the claim. This is accompanied by strict wording requirements so as to not mislead consumers. This claim can be used when there is emerging scientific evidence and must be accompanied by a disclaimer to communicate with consumers the level of scientific evidence available that supports the claim. While this is not a claim that will be unique to the applicant or company, it can provide a company who is first to market with the claim a distinct marketing advantage.

Nutrient Content Claims: this is a claim that states the level of a nutrient in a product. Any claims made outside of the nutrition facts label, such as ‘good source of…’, ‘free’, ‘high’, ‘low’, etc., are considered nutrient content claims.

Structure-Function Claims: these claims describe the role of a nutrient or ingredient on the structure and function of the body. Generally, using these claims does not require FDA notification or pre-authorization. An example of this would be “Fiber supports bowel regularity”. There are two types of Structure-Function Claims which are listed below. If a product contains a Structure-Function type of claim it must include a disclaimer stating that the FDA has not evaluated the claim, and the product is not intended to “diagnose, treat, cure or prevent any disease”, because only drugs are legally able to state these types of claims.

• Claims of General Well-Being: this is pretty self-explanatory and is a structure-function claim that describes general well-being to expect from consuming an ingredient or nutrient.

• Nutrient-Deficiency Disease Claims: these structure-function claims describe a benefit associated with a nutrient deficiency disease, such as vitamin C and scurvy. These are only allowed if a statement is made related to the prevalence of the disease, and a company must submit a notification to the FDA with the claim’s language no more than 30 days after the product has been first marketed or launched.

It's important to note that the FDA specifies where the above claims can be used, and they may not apply to all foods, beverages, and dietary supplement products out there. For example, on dietary supplements, companies are allowed to use health claims, nutrient content claims, or structure function claims.

Claims and Consumers

Marketers strive to find the best claim for their products, one that will resonate well with consumers and result in not only one purchase, but many repurchases of their product. In order to do this, they need to first understand what consumers want. Companies will spend hundreds of thousands of dollars understanding market trends including new products consumers are asking for (protein, collagen, unique nutraceutical ingredients that target specific diseases, etc.), health trends, technology trends, diseases consumers are dealing with, illnesses that are on the rise, what consumers are looking for from their products (convenience, taste, packaging, etc.), and what claims resonate best with them. There are multiple different ways that companies will gather this information. They may compile it via consumer surveys, focus groups, or purchase existing data that other companies gather and sell. They may collect this data early on in the process of innovation and close to market launch just to ensure that their product will still meet consumer needs.

A lot of behind-the-scenes work is done to ensure a product will be successful before it is launched. Companies spend a significant amount of money on new product development because they want to ensure that new products will be successful. One of the main things that helps make products successful is the claims language that can be used.

Reputable companies will perform pre-clinical and clinical research trials on products they are developing, which help them to back the claims they want to use. They will also ensure their marketing and claims language complies with federal regulations. Not doing so may result in hefty fines, loss of market share and consumer trust.

Challenges with this system

There are several challenges with this system. One discussed above was that the onus is placed on the company or manufacturer. For the large, long-standing manufacturers with a brand, image, loyal consumer following, and consumer trust to maintain, following these regulations is an absolute requirement. The alternative is to potentially have their reputation questioned, pay a large fine, have their product(s) removed from the market, have their name appear negatively in the media, and lose consumer trust, which translates into a lot of lost existing and potential revenue.

Unfortunately, though, it’s very easy for new companies to pop on the market (especially online), who may not have a reputation to maintain nor care about the risks that exist. They may try to launch a product with a claim that is not supported by evidence just to earn some quick cash. Ultimately this puts the consumer at risk.

This happens more often than not unfortunately. One example of this is from March of 2022. The FTC banned two Texas companies, owned by the same individual from advertising or selling their dietary supplements which made unsubstantiated and misleading claims. The claims on a Heart formula and a Black garlic product stated that they prevented or treated cardiovascular disease and cured diabetic neuropathy. A director at the FTC stated, “This order banning the respondents from the supplement industry should put an end to their long history of making baseless claims that their products treat various diseases. People with serious health concerns should rely on their health professionals, not advertisements,” (Federal Trade Commission, 2022).

This shines a light on the second challenge, that companies can launch a product, make some quick cash, and then ask for forgiveness later. With the onus on the company, there is an assumption that the company will operate with honesty.

In another example, a Tokyo based company applied for GRAS (Generally Recognized as Safe) status of a new ingredient they said supports brain health, decreases stress, depression, and improves sleep. The FDA denied their request stating that they needed to submit an NDI (New Dietary Ingredient) application as their product did not have enough safety or efficacy data to support it going to market. An NDI application is a lengthy process, albeit one that helps to protect both the company and consumer. What did the company do? They launched the product anyway and are still on the market today.

In the US, the FDA does not approve dietary supplements for efficacy and safety before they reach the consumer. One exception to that is if something in a product is considered a New Dietary Ingredient (NDI), as mentioned above. NDIs are ones that have not been marketed in the US prior to 1994 and are not considered to be regularly consumed in foods and beverages. The company that launches the product is responsible for ensuring the ingredient and claims not only adhere to regulatory standards but have been validated through pre-clinical and clinical safety and efficacy studies. In both above examples where the FTC ruled against the companies, the onus was on the companies, and they clearly did not do their pre-launch safety and efficacy scientific studies to validate the claims they used or gain the required status to launch a product that is considered safe.

At the end of the day

It is up to consumers to hold the companies with whom they spend their hard-earned cash accountable for delivering safe and trusted products. Can harm be done by products with false and misleading claims? Without a doubt the answer is yes. False and misleading claims may absolutely lead to harming someone’s health because if a consumer takes a product where the claims are not validated, they may be consuming something that is harmful or simply not doing anything at all. And if the claims on the package are misleading, it begs the question, what else could be amiss with the product.

While this article is on claims, there’s more to ensuring a product is safe than just the claims language on the package. Are the ingredients used safe? Are the levels used safe? Is it efficacious? Is the source of the ingredient reputable? Has it been adulterated somehow? Has it gone bad or become oxidized? Is the label accurate and does the product contain what it says it does?

It gets more concerning when it comes to health claims coming from influencers who are self-proclaimed experts on social media. Some are actually experts with reputable degrees they can stand behind. Many are not. Many are simply savvy marketers. We are in a misinformation age unfortunately, and health misinformation has been called one of the major threats to life expectancy, along with major diseases. There is no regulation on the information coming out of social media, it’s the wild-wild west and it’s easy to fall prey to sexy messages coming from non-expert influencers that could come with devastating health consequences.

At the end of the day, it’s hard work being a consumer. Ultimately, the way the system is designed for new and existing products should work, but it doesn’t always. So, it’s up to the consumer to do the homework. Look at the company, call the company, ask for their quality data, ask for their scientific evidence, and hold them accountable. Check in with your trusted health care advisors and do your homework on those health advisors. Do they have a reputable degree, did your expert put in their own hard work, or did they simply secure a certificate that took them 6 months or less to get online.

As consumers it is our responsibility to be our own health advocate. Don’t be afraid to ask all the questions and demand the answers you deserve.

Types of questions to ask

The best thing to do as a consumer is to seek out and purchase from reputable companies. Has the company been on the market for a long time and does the company have a lot to lose? When purchasing online or from a third party website like Amazon, check who the seller is. Is it a company you recognize or someone else entirely? And when in doubt, before taking anything new, or making any changes to your existing diet or health routine, ask a lot of questions and check in with the trusted and expert health care providers.

Questions for companies specifically:

• What data supports the claim you’re making on your product?

• Can you send me or direct me to your scientific data?

• Is there a monograph on your product or ingredient?

• Where is your product produced?

• Where do you source your ingredients?

• Has your product and ingredients been third party tested for safety, stability, and to ensure it meets label claims?

• Could you send me your quality documentation? (certificate of analysis)

Questions for experts specifically:

• What is your degree?

• What were the requirements of obtaining the degree?

• Can you direct me to a website where I can learn more about your degree?

• What are your continuing education requirements?

• Are you licensed and in which state(s)?

• What do you have to do to maintain your license or registration?

• Are you registered or board certified?

• Are there others in the field who have similar or better qualifications?

• How long have you been practicing?

• Do you have a private practice or see patients one-on-one?

• If yes, where is it?

References

Council for Responsible Nutrition. (n.d.). Product Claims. Retrieved from https://www.crnusa.org/regulation-legislation/fda-ftc-regulations/product-claims

Federal Trade Commission. (n.d.). About the FTC. Retrieved from https://www.ftc.gov/about-ftc

Federal Trade Commission. (2022, March 16). FTC Proposed Order Stops Marketers from Continuing to Promote Supplements Using Baseless Health Claims [Press Release]. Retrieved from https://www.ftc.gov/news-events/news/press-releases/2022/03/ftc-proposed-order-stops-marketers-continuing-promote-supplements-using-baseless-health-claims

Food and Drug Administration. (2018, December 14). Introduction to Food Product Claims. FDA Reader. Retrieved from https://www.fdareader.com/blog/2018/12/14/introduction-to-food-product-claims

Kadakia, K.T., Beckman, A.L., & Krumholz, H.M. (2023). A prescription for the US FDA for the regulation of health misinformation. Nat Med 29, 525–52. https://doi.org/10.1038/s41591-022-02172-9

Levi, B. (2015, August 5). The Science Behind Marketing Claims. Natural Products Insider. Retrieved from https://www.naturalproductsinsider.com/manufacturing/the-science-behind-marketing-claims

Neltner, T. (2022, January 5). Broken GRAS: It’s time for the FDA to wake up and protect consumers from dubious ingredients [Blog]. Environmental Defense Fund. Retrieved from https://blogs.edf.org/health/2022/01/05/broken-gras-its-time-for-fda-to-wake-up-and-protect-consumers-from-dubious-ingredients/

U.S. Department of Health & Human Services, National Institutes of Health, Office of Dietary Supplements. (2020). Background Information: Dietary Supplements. Retrieved from https://ods.od.nih.gov/factsheets/DietarySupplements-Consumer/

U.S. Food and Drug Administration. (2022). Authorized Health Claims That Meet the Significant Scientific Agreement (SSA) Standard. Retrieved from https://www.fda.gov/food/food-labeling-nutrition/authorized-health-claims-meet-significant-scientific-agreement-ssa-standard

U.S. Food and Drug Administration. (2018). Guidance for Industry: Notification of Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body. Center for Food Safety and Applied Nutrition, FDA-1998-D-0102. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-notification-health-claim-or-nutrient-content-claim-based-authoritative-statement

U.S. Food and Drug Administration. (2022). Label Claims for Conventional Foods and Dietary Supplements. Retrieved from https://www.fda.gov/food/food-labeling-nutrition/label-claims-conventional-foods-and-dietary-supplements

U.S. Food and Drug Administration. (2023). New Dietary Ingredients in Dietary Supplements – Background for Industry. Retrieved from https://www.fda.gov/food/new-dietary-ingredient-ndi-notification-process/new-dietary-ingredients-dietary-supplements-background-industry

U.S. Food and Drug Administration. (2022). Structure/Function Claims. Retrieved from https://www.fda.gov/food/food-labeling-nutrition/structurefunction-claims

U.S. Food and Drug Administration. (2022). Qualified Health Claims. Retrieved from https://www.fda.gov/food/food-labeling-nutrition/qualified-health-claims

U.S. Food and Drug Administration. (2017). Questions and Answers on Health Claims in Food Labeling. Retrieved from https://www.fda.gov/food/food-labeling-nutrition/questions-and-answers-health-claims-food-labeling