This is Part 1 (of 4) in the Supplement Savvy series by Jeremy Appleton, ND, CNS. Other articles include:
Part 2: Product Potency
Part 3: Finding Authentic Herbal Supplements
Part 4: Quality and Purity
Understanding Food Labels
What goes on to the labels that grace the boxes and bottles of foods and supplements in the United States is closely regulated by U.S. Food and Drug Administration and by the Food Safety and Inspection Service of the U.S. Department of Agriculture (USDA). Apart from branding and the basic identity of what’s in the package (e.g., turkey dogs or orange juice), packaged food labels contain other key features that regulatory agencies have determined are important for consumers to understand about the nutritional composition of the foods in the package: information on the amount per serving of saturated fat, cholesterol, dietary fiber, or of other nutrients of major health concern.
Regulators have also developed uniform definitions for the terms that describe a food’s nutrient content to ensure that such terms mean the same for any product on which they appear. Terms like “light” or “low-fat” or “high-fiber” have specific meanings and the foods must comply in order for the terms to be legally used on a label. Serving sizes have also been standardized to make nutritional comparisons of similar products easier; nutrient reference values, expressed as “% Daily Values” were developed to help consumers see how a food fits into their overall daily diet; and the total percentage of juice that appears in juice drinks must be declared.
A great deal of scientific research has been published in peer-reviewed medical journals relating to the health effects of certain foods and their constituent nutrients. Claims about the relationship between a nutrient or food and a disease or health-related condition are also tightly regulated by the FDA. Only certain claims have been given the green light by the FDA, and only after there is significant scientific agreement in the medical community that the claims are true, and the preponderance of evidence is more or less beyond any reasonable dispute. These claims include such relationships as that between calcium and osteoporosis, or between fat intake and cancer.
The Nutrition Labeling and Education Act of 1990 (NLEA) requires nutrition labeling for most foods (except meat and poultry) and authorizes the use of nutrient content claims and appropriate FDA-approved health claims. Certain foods are exempt from labeling, most commonly food served for immediate consumption, such as food served in hospital cafeterias and airplanes, from food service or sidewalk vendors, or from vending machines. Ready-to-eat food that is not for immediate consumption but is prepared primarily on site is also exempt, such as bakery, deli, and candy store items. Food shipped in bulk, as long as it is not for sale in that form to consumers, is exempt. Medical foods, plain coffee and tea, some spices, and foods that contain no significant amounts of any nutrients are also exempt from labeling.
Under the label’s Nutrition Facts Panel (NFP), the manufacturer is required to provide information on certain nutrients. The mandatory nutrients and voluntary components must be listed in a designated order on the label. If a claim is made about any of the optional components, or of the food is enriched or fortified with any nutrient, then the information for that component becomes mandatory. Unlike supplement labels, these mandatory and voluntary food components are the only ones allowed in the Nutrition Facts Panel of a food label.
Understanding Supplement Labels
To understand supplement labels, it is first necessary to understand what a “dietary supplement” is. The U.S. Congress defined the term “dietary supplement” in the Dietary Supplement Health and Education Act (DSHEA) of 1994. It refers to a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet. The dietary ingredients in these products may include vitamins, minerals, whole herbs, botanical extracts, amino acids, other ingredients such as enzymes, organ tissues, glandulars, and nutritional metabolites.
Dietary supplements can also be extracts or concentrates and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as an edible bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet.
Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of “foods,” not drugs, and requires that every supplement be labeled a dietary supplement. For decades, the FDA regulated dietary supplements as foods to ensure that they were safe and wholesome, and that their labeling was truthful and not misleading. FDA’s authority to review the safety of all new ingredients was under the 1958 Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C; Act). With the DSHEA, Congress amended the FD&C; Act to include several provisions that apply only to dietary supplements and dietary ingredients of dietary supplements. As a result, dietary supplement ingredients are no longer subject to the pre-market safety evaluations required of other new food ingredients or for new uses of old food ingredients.
Who Ensures a Dietary Supplement is Safe?
Under DSHEA, the supplement manufacturer is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements, unlike drugs, do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.
Also, manufacturers do not need to register themselves nor their dietary supplement products with FDA before producing or selling them. Only recently has the FDA implemented regulations that are specific to dietary supplements that establish a minimum standard of practice for manufacturing dietary supplements. These Good Manufacturing Practices (GMPs) are still in the implementation phase and focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements. Until recently, manufacturers and distributors of dietary supplements have not been required by law to record, investigate or forward to FDA any reports they receive of injuries or illnesses that may be related to the use of their products. Under DSHEA, once a product is marketed, FDA has the responsibility for showing that a dietary supplement is “unsafe,” before it can take action to restrict the product’s use or removal from the marketplace.
Structure Function Claims
Dietary supplement labels or labeling may bear statements that describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function. Such statements may not be disease claims. For example, a manufacturer can say that taking the herb saw palmetto “supports healthy prostate function”, but they cannot say that taking the herb “reduces the symptoms of benign prostatic hyperplasia,” even if that statement is true and well-documented in the medical literature. FDA would consider the product to be misbranded as a drug if such a statement appeared in labeling or accompanying literature for a dietary supplement.
Dietary supplements can use claims about nutrient deficiency diseases. For example, vitamin C deficiency results in a disease called scurvy, and it is permissible to mention that fact, though it is probably not the most popular marketing tool since these deficiency diseases are uncommon in developed countries. Manufacturers are also permitted to make claims that describe the effect of the dietary supplement on general well-being. To make a claim, a manufacturer must have substantiation that the claims are truthful and not misleading. They must notify FDA that they are using the claim within 30 days of first marketing their product. And they must include a mandatory disclaimer statement that is provided for in the law:
This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.
Making Sense of the Label
Trying to make sense of a label can seem daunting at first. But stay with it and read closely, and the information should become clear. If you closely read a supplement label and you still have difficulty figuring out what is in the bottle (i.e., the identity of the ingredients is not clear), or how much of a particular ingredient is in a serving, or how much you should be taking…it should raise some red flags. Reputable companies put a significant amount of effort into clearly communicating the necessary information to you in accordance with regulatory standards.
When comparing similar products, keep in mind some basic information: How many milligrams of the key ingredients are there in a serving? How many servings are you instructed to take per day? How many capsules or tablets are there in a bottle? How much does the bottle cost. With the answers to these questions written down, it becomes a simple matter to compare products. Bring a calculator with you to the store. That cheaper-by-the-bottle product may not be cheaper at all when looked at from the vantage of the cost-per-month. So spend a little time writing down the key information when comparing products. The following process can give you a handy way to compare different products:
1) First figure out how long a bottle is going to last you. If you are taking 1000 mg per day of vitamin C, and there are sixty 500-mg capsules in the bottle, then you know you have a month’s supply. Divide 1000 mg/day by 500mg/cap = 2 caps/day. Divide 60 caps/bottle by 2 caps/day = 30 days/bottle.
2) Next, figure out how much a month’s supply is going to cost you. If the bottle provides a month’s supply, then it’s easy: just the cost of the bottle. But if the bottle in the example above only gave you fifty caps, then you would only be getting a 25-day supply. If the bottle cost $10.00, your monthly cost would be the cost of the bottle ($10.00) x 30 = 300, then divide 300 by 25 = $12.
All of this assumes that the quality of the two products under consideration is equal, and that is often not the case. It is usually worth paying more for a high-quality product. In upcoming segments, we will look at issues affecting product quality, such as purity, potency and authenticity.
In Part 2 of this four-part series, Product Potency, we will examine some of the vital criteria used to measure nutritional supplement potency.