By EAS Independent Consultant, David Cockram, PhD
Nearly every athlete wants something extra that will provide them with an edge over the competition. Optimizing nutrition is certainly a huge part of improving athletic performance. A well-balanced diet, with appropriate levels of carbohydrates, proteins, healthy fats, and other nutrients is necessary as a foundation for performance. But a growing body of evidence suggests that targeted supplementation may well be the magic that boosts performance. Consequently, sports nutritionals are big business and widely used by weekend warriors and elite athletes alike.
Developing a new product typically begins with identifying an unmet need and then finding the right combination of ingredients, packaging, and claims to address the consumer need at an acceptable product cost. Along the way, there are a number of regulatory considerations to be addressed before a product can be legally marketed. Close cooperation between product developers, marketers, quality assurance, and regulatory affairs professionals is needed throughout the development process. This is a high-level review of some of the more common regulatory considerations, but each product is different and may have novel factors that need to be reviewed. These include: (1) product category, (2) regulatory status of each proposed ingredient, (3) labels, and (4) claims and claim substantiation. Other factors, such as packaging compliance and sustainability considerations may also require review but not covered here.
In the United States, sports nutrition products are either conventional foods or dietary supplements. Conventional foods can be thought of as products consumed primarily for a “food-like” purpose (e.g., taste, aroma, hydration, satiation of hunger, provision of significant nutrients, etc.). Foods have Nutrition Facts panels and labels can bear structure-function and authorized nutrient content or health claims (more on types of claims below). With a few exceptions, conventional foods are intended for consumption by the general population.
Dietary supplements are products taken by mouth that contain a “dietary ingredient.” Dietary ingredients can include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet. Although dietary supplements are most commonly in tablet, capsule, softgel, gelcap, or powder form, they can be bars or liquids as well. Dietary supplements have Supplement Facts panels and labels include primarily structure-function claims along with a disclaimer indicating that the FDA has not reviewed the claim. Unlike most conventional foods, dietary supplements can be targeted to specific audiences.
Determining whether a proposed product is more appropriately labeled as a conventional food or as a dietary supplement is usually fairly straight forward. For products like bars, that could be either a conventional food or dietary supplement depending on whether used/characterized as a food or as simply a delivery vehicle for a dietary ingredient, the assessment can be more complicated. Getting the categorization right is important to assure that the appropriate standard is used for applying the appropriate safety standard for novel ingredients (i.e., GRAS vs New Dietary Ingredient), label compliance, and permissible claims.
Regulatory Status of Ingredients
Once an unmet need in the marketplace has been identified, a search is initiated to identify ingredients to address the need. While many ingredients have long histories of safe use, sometimes product developers will want to consider novel ingredients (i.e., ingredients that are new to the food supply or used in a different way than they have been used historically).
For conventional foods, all ingredients must either be an approved food additive or Generally Recognized As Safe (GRAS). The steps to go through either process are beyond this short review. For ingredients with a history of safe use in conventional foods, it is always good to review the Code of Federal Regulations and FDA’s GRAS database to assure that the ingredient can be used for your intended use and use level. For novel ingredients, or for existing ingredients that are used for a new purpose that is outside of the original approval, a new or updated regulatory review will be needed before they can be used in foods.
For dietary supplements, the safety standard for dietary ingredients is differs, a reasonable expectation of safety given the intended use. If an ingredient was not demonstrably marketed as a dietary ingredient prior to October 15, 1994, then it may be considered a New Dietary Ingredient and prior FDA notification is required. Because the analysis of whether an ingredient is “New” or not can be complicated, expert assistance is recommended. EAS can help.
Labels are both marketing and regulatory documents and are best approached as such. Marketing information such as product branding, claims, and instructions for use are as critically important to product success as regulatory compliance information such as nutrient composition data (i.e., the Nutrition Facts or Supplement Facts panel), ingredient listing, allergens, manufacturer name and address, and other required information. Careful planning is required to assure that all required information, as well as the desired marketing copy, can be accommodated, especially where label real estate is limited or oddly shaped. Where the product has additional certifications, such as organic, vegan/vegetarian status, or GMO content there may be additional label space required to allow for placement of logos and certifier’s name. While there is a fair bit of flexibility in most labeling regulations, there are also a lot of seemingly small details that are specified explicitly by regulation. Careful scrutiny of the proposed label by all members of the team is crucial to assure it is both compliant as well as effectively communicates the product’s attributes and benefits.
Claims and Claim Substantiation
For a sports nutrition product to be commercially viable, the marketer needs to be able to communicate its benefit to the consumer. There are three general types of claims for foods: structure-function (relationship between consumption of a food or ingredient and maintenance of the normal structure or functioning of the body), nutrient content claims (claims that characterize levels of specific nutrients in foods), and health claims (relationship between consumption of a food or food constituent and potential reduction risk of a disease in the future. Most sports nutrition claims are of the structure-function variety.
From a commercial perspective, claims need to be as compelling as possible. The commercial desire for strong claims must be tempered with regulators’ expectations for claims that are truthful, non-misleading, adequately substantiated, and appropriate for the product category. There must be appropriate substantiation for any express or implied product claim. In the best of all worlds, the supporting data for claims is gathered using the actual product in humans under the intended conditions of use. However, in many situations, this ideal level of substantiation isn’t available and claims must be based on ingredient data, animal studies, human studies in other population, and sometimes even in vitro data. Claims based on less direct evidence need to be worded carefully to reflect the indirect nature of the substantiation. Animal or in vitro data can be useful to explain mechanisms of action but regulators typically would not consider such data to be adequate as the sole substantiation for claims. Fortunately, most regulatory agencies have claim substantiation guidance documents, as well as extensive databases of warning letters that have gone out to people who haven’t gotten it right, to assist in developing appropriate claim language.
In summary, sports nutritionals have exciting potential to help improve human performance at all levels of athletic endeavor. Although they are typically fairly straight forward products from a regulatory standpoint, each one requires careful review of a number of factors to assure full compliance.