Ensuring dietary supplement product integrity, from ingredients to claims

Integrity is the quality of being honest and having strong moral principles, according to the Google definition. Integrity implies trustworthiness and per Merriam-Webster, “firm adherence to a code of especially moral or artistic values: incorruptibility.”

In our market integrity department at New Hope Network and SupplySide (both owned by Informa Markets, which also owns the media brand you’re reading this article on), we include honesty, transparency and responsibility in our definition of product integrity. But perhaps a more important question is, “What does product integrity mean to you?”

In the natural products industry, there are many products that we love and enjoy, and new products are entering the market every day. What brings these products their magic? Is it the amazing ideas? Is it the innovative formula or delivery forms? Or is it the beautiful presentation, including gorgeous packaging with brilliant labels? Maybe it is a combination of these attributes, plus the incredible product story. Whatever it is, we all want to be sure the product meets regulations and consumers enjoy its benefits.

What is the secret to great products with high product integrity?

Let’s consider what keeps most entrepreneurs up at night. Our clients’ primary concerns are labels and marketing compliance (aka claims). The most common question and concern is, “What can I say and how can I say it?”

Ironically, these same concerns are also the two areas which may slow down a new brand or product from a successful launch into the U.S. market. Many retail buyers are trained to recognize egregious product errors. Despite good intentions during product design — and all the efforts to get a product to a trade show — at times, impermissible statements on the product label, missing nutritional facts, incorrect formatting or other common deficiencies could weaken a product’s first impression … Or possibly prevent a company from being able to display such a product at an industry trade show.

Companies wishing to exhibit their products at a New Hope Network event (such as Natural Products Expo West) are subject to our ingredient standards and guidelines. For example, foods, dietary supplements or cosmetics may not contain artificial colors, flavors or sweeteners.

With each exhibitor application, our team of specialists reviews product labels and literature to ensure the company meets New Hope’s ingredient requirements and basic labeling regulations, and we alert brands if something needs to be changed. When applicable, our standards team will recommend new and existing exhibitors reach out to our MarketReady insights regulatory consulting team for additional assistance (these services are also available to non-exhibitors).

Here’s a quick peek into our process:

Overview of product claims

First, proper product claims are essential to tell a brand’s story. When it comes to market integrity, we want to help communicate your product story while doing it with compliant language. Most CPGs are regulated by the U.S. Food and Drug Administration. Most commonly, we see food, dietary supplements, consumer health care products and occasionally devices. Each product commodity has its own regulatory pathway. When it comes to product claims and label statements, in general, supplement brands can support wellness and health. Being able to differentiate a product with claims and integrity is a bit of an art. Sometimes, it’s nice to have a guide.

For dietary supplements, a brand can make a claim about the product benefits, a specific nutritional component or dietary ingredient in the product. Dietary supplements can make four types of claims: structure/function claims, health claims, qualified health claims and nutrient content claims. Each has its own unique application and limitations.

Structure/function claims were introduced by the Dietary Supplement Health and Education Act of 1994 (DSHEA). This is the most common claim made for dietary supplement products.

When making product claims, issues arise when products claim to treat, prevent or cure any abnormal states of the body (aka disease states) or symptoms of disease states. FDA warning letters often include language related to intended use. When a marketer makes statements that involve treating, preventing or curing the body, the product will likely be recognized by regulatory authorities as a drug due to the intended use (aka treating an ailment).

Making drug claims has many regulatory consequences. FDA good manufacturing practices (GMPs) for drugs — and fulfilling expectations for a drug regulatory filing and approvals — are extensive, time consuming and expensive. This is a regulatory line most food and dietary supplement products don’t intend to cross. Hence, understanding how to legally craft compliant marketing statements (claims) for a product is essential!

Making truthful and non-misleading product claims is about supporting the healthiest version of consumers and ourselves. Structure/function claims allow describing a nutrient's role in affecting the body's normal structure or function. This is often a gentle shift in the language utilized but it may take some thought.

During product development, most concepts have an intended use in mind — how we want the consumer to benefit. In the natural products space, it's critical to remember the best version of ourselves before experiencing health breakdowns. Our products are most impactful at this stage. For example:

• Before obesity, there was healthy weight management.

• Before gas and bloating, there was healthy digestion, diet and lifestyle.

• Before inflammation, there was healthy joint mobility supported by an active lifestyle and proper nutrition.

The key is making truthful claims that support the healthiest version of consumers. Plus, a brand wants to be sure it can support and substantiate these statements with scientific evidence.

For conventional food products, structure/function claims “focus on effects derived from nutritive value, while structure/function claims for dietary supplements may focus on non-nutritive as well as nutritive effects,” per the FDA website. For example, an acceptable claim may include, "Calcium builds strong bones.” At times, brands could also lean into nutrient content claims or authorized health claims, as described by the FDA on its website in Part 101.72 - 101.83 of Title 21 of the Code of Federal Regulations.

Writing compliant nutrient content claims (21 CFR Part 101.13) is hard for many businesses. During the product development phase and while developing marketing copy, it is often misunderstood that many descriptors have already made their way into FDA definitions, including “low,” “high” and “antioxidant.” To use these terms on the label requires meeting FDA definitions to avoid misbranding.

Natural products checklist

Brands also need to consider their use of common terms and artsy seals like organic, non-GMO (genetically modified organism) and “no” (as in, a product does not contain) statements on food packaging. When using these terms, consumers want brands to be honest and transparent. That helps build brand loyalty. Regulators also expect appropriate use of seals and label statements to ensure they are truthful and not misleading. Finally, and unfortunately, misuse of seals or unfounded label promises may also make a brand the target for class action lawsuits.

Here’s a natural products checklist based on common issues we see:

A helpful resource for labelling your product with integrity is the FDA Food Labeling Guide, which describes many required elements on a product label for food and dietary supplements. While we focus on the five basic label components for eligibility at our shows, there are likely countless regulatory and strategic details to ensure a label looks amazing to the retail buyer, consumer and regulators.

A label is a product’s first impression, and it says a lot about a brand. Shine! Show your product integrity is the best in class.