There’s an art and a science to making a dietary supplement label: approach product branding like a miniature work of art and double-check the science behind your label’s claims and you won’t go far wrong. Wording supplement labels clearly with factual claims, conveying the message that a product is worth putting into the consumer’s real or virtual shopping cart, all while abiding by relevant regulations, however, is no easy feat. Below, we dive into what you should know about dietary supplement labels, including the “supplement facts” panel, ingredients, product label claims, and quality considerations.
Dietary Supplement Claims Constructed Properly: Supplement Facts
Dietary supplements generally refer to any product taken by mouth that contains a dietary ingredient, which can be a vitamin, a mineral, an amino acid, and herbs or botanicals; it could also be other substances intended to supplement the diet. Or, a concentrate, metabolite, constituent, extract, or combination of any ingredient intended above.
This is why compared with a nutrition facts panel of a regular food product, dietary supplements must have a “Supplement Facts” panel focused on listing the content of dietary ingredients. Below are sample Supplement Facts and Nutrition Facts panels from the FDA website.
Also included in this section is most of the basic information about a supplement, such as the serving size, number of servings per container, and amount of each nutrient that it contains—for vitamins and minerals, this is usually listed as the Percent Daily Value (%DV), which is based on the estimated nutritional needs of someone who’s on a 2,000-calorie diet. Here you may also notice the Tolerable Upper Intake Level (UL). This helps reminds consumers of the maximum daily intake that’s unlikely to cause adverse symptoms or side effects.
The FDA defines 3 different categories of claims permitted to use on the packaging of dietary products: health claims, nutrient content claims, and structure/function claims. Each category has its own specific set of regulations that manufacturers should take notice of.
1. Health Claims
A health claim is any evidence-based statement about a relationship between food and health, such as the growth, development, and functions of the body. Note that a health claim is different from a disease claim, which states that a product can treat, mitigate, or cure a disease. Disease claims are exclusive to drugs and certain devices, while health claims are limited to disease risk reduction.
The FDA distinguishes two types of health claims. Food or supplement manufacturers must gain FDA approval to use any of these:
• Authorized: Claims meeting a standard of “significant scientific agreement (SSA),” which means the claim is supported by all available public scientific evidence.
• Qualified: Claims backed by significant scientific evidence, but don’t meet the requirements for the SSA standard. To prevent misinformation, these claims must include a disclaimer to make the amount of scientific evidence clear.
2. Nutrient Content Claims
A nutrient content claim describes the level of nutrients or dietary substances in the product, using defined terms such as free, high, low, more, reduced, or lite. Phrases like low-fat, high-potency, or sugar-free have to meet specific nutritional thresholds. The majority of nutrient content claims apply to ingredients with an established Daily Value (DV). Another way to characterize the level of a nutrient in a dietary supplement is through percentage levels, which are not allowed for regular food products.
3. Structure/Function Claims
Structure/Function claims describe the role of a nutrient or ingredient on the structure or function of the human body, and they are the most common, permissible claims used for dietary supplements. Some examples include “fiber maintains bowel regularity” and “antioxidants maintain cell integrity”. To use an S/F claim, a disclaimer must be added to communicate that the product is not intended to diagnose, treat, cure, or prevent any disease. Otherwise, including an S/F claim implying disease management on a dietary supplement product would be considered misleading and out of compliance.
Judging from the Label, What’s Inside the Bottle?
Dietary Ingredients
Dietary ingredients are essentially the intended active ingredients fulfilling the product claims shown on the labels. These may provide consumers with functional added values, unique taste experiences, or serve as new alternatives as people avoid certain foods for some reason.
From general health needs to hard-to-find specialties, bulk ingredient sourcing is what we do at Klee. You can find more information about our offerings in this previous post: Find Ingredients Bulk Supply You Need: Full Ingredient List by Klee.
Non-dietary Ingredients
Non-dietary ingredients, including excipients, fillers, and other additives, refer to any “non-medicinal” compounds used to assist in manufacturing. Though not intended to have active effects, non-dietary ingredients improve product factors such as the supplement’s stability (safety), appearance, texture, or taste. They are usually found below the supplement facts panel in an ingredient statement, labeled as either “ingredients” or “other ingredients”.
Some of the most common additives found in food supplements include cellulose, stearic acid, gelatin, soybean oil, maltodextrin, silicon dioxide, soy lecithin, and magnesium stearate. Even though in some cases, non-dietary ingredients are needed to ensure processed food remains safe and in good condition, it’s best to steer clear of formulations that contain a long list of additives.
Standardized Extract
A standardized extract is an herb or botanical extract that delivers a specific, guaranteed amount of one or more active constituents, usually expressed as a percentage. For many botanical ingredients to be used medicinally, scientists have to first identify the primary biologically active constituents (known as bioactive compounds)—these tend to be found in higher amounts in the medicinal portion of the plant.
Standardized extracts include the whole herb but are chemically designed to ensure the potential potency is consistent from batch to batch. On the label of herbal supplements, you can often find the phrase “extract standardized to contain…” in the supplement facts panel.
Proprietary Ingredients or Blend
FDA requires manufacturers to list all of a product’s ingredients on the supplement facts panel, along with the amount and proportions of each, except when the ingredients are part of a proprietary blend. The specific amount of each individual ingredient in a proprietary blend does not have to be listed; only the total combined amount in the blend must be given in descending order by weight. On the actual packaging, a proprietary blend might be listed as a “blend,” “complex,” “matrix,” or “proprietary formulation.”
Sourcing 3rd Party-Certified Supplement Ingredients
To create the best dietary supplements that support certain label claims we discussed earlier, first you need to get your hands on quality ingredients. While this may seem obvious enough, the research beforehand and nurtured relationships required to obtain superior ingredients can sometimes be overwhelming. Fortunately, several standards come in handy in terms of measuring the quality and safety of manufacturers/suppliers.
These regulations provide a business with a set of policies and procedures to appropriately review and analyze food safety risks and hazards. Some of the gold standards include:
• Hazard Analysis Critical Control Point (HACCP)
• ISO, such as ISO 22000
• GMP certification from SGS
As consumers are examining what’s in their food and dietary supplements more carefully, manufacturers may voluntarily acquire other certifications from third-party organizations—these independent agencies assess and verify different factors involved in product development, manufacturing, labeling, and distribution to meet different customer demands.
Common examples of third-party certifications shown on a supplement label include:
• B Corp Certification
• Certified Gluten-Free
• Certified Vegan
• Non-GMO Verified
• USDA certified organic
• Certified Halal
• Certified Kosher
In this previous article, we explored the difference between the two certifications and introduced our certified offerings to help you prevail in the Kosher and/or Halal markets.
Terms We Use to Identify Our Products
Dietary supplement labels often contain terms like “all-natural” or “organic,” which may be confusing for consumers as well as manufacturers. Listed below are some terms commonly labeled on the packaging.
1. Natural
While the FDA has no formal definition for what the term actually means, “natural” supplements often refer to products that don’t contain any artificial or synthetic ingredients, including artificial flavors or colors. The word “natural” currently does not address food production or processing methods, such as the use of pesticides, thermal technologies, pasteurization, or irradiation.
2. Organic
Dietary supplements can be marketed as organic, as long as they have been produced according to the standards in the Organic Foods Production Act (OFPA) and certified by USDA’s National Organic Program—a label may only use the “USDA Organic” seal if the food is actually certified organic. Ingredient-wise, organic supplement products contain only herbs, vitamins, or minerals derived from organic plants or animals.
3. Food-based or whole food
Some products are referred to as “food-based” or “whole food” supplements. These products are usually made by removing the water content from whole foods, including herbs, “superfoods”, and grains. Some food-based supplements also use animal sources; organ meats in particular are high in key mineral compounds. In addition, food-based supplements may include co-nutrients that promote metabolism and make efficient use of vitamins, enzymes, and probiotics to enhance digestion.
4. GMO-free
Many consumers around the world are demanding “non-GMO” food products due to concerns about food allergies, antibiotic resistance, and their potential long-term health effects. When a dietary supplement is labeled and advertised as GMO-free or non-GMO, it means that the supplements are produced without any genetically modified ingredients.
5. Vegan
Perhaps surprisingly, some of the most popular ingredients of dietary supplements are in fact animal products, such as gelatin, collagen, glucosamine & chondroitin, and hyaluronic acid. But as the number of vegans is on the up, the consumer dietary trend has already caught the attention of the supply side. Vegans and omnivores alike should be on guard against nutrient deficiencies, but vegans are more likely to fall short on a few key nutrients, especially B12, Vitamin D, calcium, iodine, protein, and zinc.
When selecting a dietary supplement, reading the ingredient label is key. And when it comes to catching a consumer’s interest, seconds matter. Food supplement labels are supposed to inform, protect, and engage consumers. By deciphering some crucial elements of dietary supplement labels, you can begin with the end in mind, create supplement products more effectively, and deliver with greater impact.
Reference:
https://www.fda.gov/food/dietary-supplements/dietary-supplement-products-ingredients
https://www.fda.gov/food/food-labeling-nutrition/label-claims-conventional-foods-and-dietary-supplements
https://ods.od.nih.gov/HealthInformation/dictionary.aspx
https://labelsunwrapped.org/
https://www.chpa.org/our-issues/dietary-supplements
https://fullscript.com/blog/reading-supplement-labels
https://www.seekinghealth.com/
https://www.fdareader.com/food-labeling
Thanks for shedding light on supplement labeling! Understanding what we put in our bodies is crucial. Your blog provides valuable insights.