One of our goals with these blogs is to help provide you with new information about various topics that may help you in making more informed decisions about the foods you eat, the beauty products you use, the lifestyle you maintain, the supplements you take and how all of these factors can come together to affect not only your general health, but the health and beauty of your hair, skin and nails. In this week’s blog we are going to take a bit of a step back, taking a broader look at supplements in general and discuss 5 things you probably didn’t know about dietary supplements. Like the fact that they can have many forms such as pill form, capsules, gel caps, gummies, powders, bars and liquids!
To begin in earnest, let’s start with something we have touched on before – unlike drugs, dietary supplements do not require FDA approval. But because there can be some risks associated with dietary supplements (in fact, we have told you about one already regarding how biotin can interfere with the results of certain lab tests), the FDA regulates them to help keep you safe and also suggests you discuss with your doctor, healthcare professional or pharmacist to make sure the supplements you are considering are right for you.
So what can the FDA do and not do? Well, they lack the authority to approve dietary supplements for their effectiveness, safety, and labeling in advance of being put on store shelves and sold to the public. Under the Federal Food, Drug and Cosmetic Act, the onus is on the manufacturers to warrant their products meet dietary supplement safety standards, and that their product contains labels containing nutrition information (a Supplement Facts label such as this one) which includes the size of the serving, the total number of servings in the container, a list containing all dietary ingredients and their amount per serving in the product and the place of business of the manufacturer or distributor. Furthermore, under the 1994 Dietary Supplement Health and Education Act, it is against the law for companies manufacturing dietary supplements and ingredients (and their distributors) to market misbranded or adulterated products. That means they are responsible for evaluating the safety and labeling of their products before putting them on shelves to ensure that they meet all FDA requirements. There must also be a statement on the front label of the product identifying it as a “dietary supplement” or similar descriptor such as “calcium supplement”. One final comment about information on the labels that you may not know. It is not necessary for companies to put expiration dates on the labels of dietary supplements. However, if a company chooses to do so, it must have valid data proving to demonstrate that the expiration date is not misleading.
The other roles of the FDA typically start after the supplement is publicly available, as companies do not need to notify the FDA of their intent to bring a new supplement to the market. But once on the market, the FDA will periodically inspect the manufacturing facilities and ensure labeling requirements are met. Not only will they look at the labels, but they can also look at the product’s website to ensure proper labeling there as well, and to confirm that no claims are made that would reclassify the products as drugs. Examples of such claims would be that they treat, cure or prevent diseases. The FDA will also keep a close eye on reports of adverse events submitted by the companies themselves, their customers, or health care professionals to keep abreast of the safety of the product once it is on the market. If they find that a product is unsafe, there are several different courses of action that can be followed – they can help the company bring the product back into compliance, they can ask the company to recall the product, or in the severest case, take action to remove the product from store shelves. That is why it is important to report an adverse effect if you think you have had one – without this information, there is not much the FDA can do in this regard.
Now back to claims. If you really want to get into the nitty gritty of the types of claims that can be put on dietary supplement label, all kinds of information about this has been provided by the FDA. But let’s take a look at a few of them here. Have you ever wondered what it means when a supplement claims it is a high source or a good source of a certain ingredient? What is high? Well, high means the ingredient is present to at least 20% of the Daily Value (DV). A good source is when it is there at the 10-19% level of the DV. But if the ingredient does not have a DV, the manufacturer can only say it is there, not that it is a “good” or “high” source of that ingredient.
Now let’s talk about the subtle difference between health claims and another type of claim called a structure/function claim. A health claim is a specific or implied account of a relationship between a substance and health related condition or disease. “This supplement will cure your acne” is a health claim. Such a claim requires significant scientific evaluation by the FDA and authorization prior to its use. On the other hand, structure/function claims describe the intended role of a substance to maintain the structure or function of the body. These types of claims do not require FDA preapproval. In one very specific instance they can appear to be very similar to a health claim - they may claim a benefit related to a nutrient deficiency disease, so long as it also discloses the incidence of that disease in the USA. They may also describe the purpose of an ingredient added with the intention of affecting the structure or function within our bodies, or simply be a statement that describes how consumption of the product will lead to our general well-being. But when using structure/function claims, you must have evidence that the claim is true and not misleading, include a disclaimer and notify the FDA. The disclaimer must say "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." and it cannot be modified.
In this blog our goal was to inform you of 5 things you probably didn’t know about dietary supplement, and we hopefully exceeded that. Dietary supplements, unlike drugs, do not require FDA approval and the rigorous scientific and safety evaluations that accompany that process. The FDA only regulates the supplement industry with specific rules pertaining to information provided on labels and claims that can be made amongst their means of regulation. The facts we have written about can help you spot a bogus manufacturer a mile away and one which will soon be in the cross hairs of the FDA by a close examination of their marketing claims and labels.