Written by: Anna Misztela, Executive Contributor
Executive Contributors at Brainz Magazine are handpicked and invited to contribute because of their knowledge and valuable insight within their area of expertise.
When you make the decision to begin taking nutritional supplements specially formulated to improve the health and appearance of your hair, skin and nails, you’ve probably already done your research on the various options that are on the market and their mix of ingredients. However, there may be a few other facts that you may not be aware of about these supplements that remain kind of behind the scenes so to speak. The goal of this article is to bring you up to speed on some of these lesser-known facts about beauty supplements, as they may help guide your final decision.
Beauty and dietary supplements do not require FDA approval
We will begin with the most important fact you should know, and that is that unlike drugs, beauty and dietary supplements do not require FDA approval. That does not mean the FDA pays no attention to them, as some supplements may be associated with certain risks. For example, biotin is a common ingredient found in many beauty supplements because of its purported effect on hair and proven ability to improve nail strength, and often it is found in very high dosages. However, high levels of biotin can mask the results of certain clinical laboratory tests that a physician may prescribe, hiding a potential underlying pathology and putting your health at risk. So, despite the fact that the FDA does not require these supplements to go through a complex and thorough approval process similar to pharmaceuticals, they do regulate supplements for issues such as the one for biotin and will suggest that you discuss your choice of supplement with your doctor to make sure it is suitable for yourself.
The onus is on the manufacturers to warrant their products meet dietary supplement safety standards
The biotin example aside, what exactly does “regulate” mean and what can the FDA do and not do? First, they do not have the authority to approve dietary supplements for their effectiveness, safety and labelling prior to these products being made available for sale to the public. According to the Federal Food, Drug and Cosmetic Act, the onus is in fact on the manufacturers to meet certain criteria such as (i) warrant their products meet dietary supplement safety standards, (ii) ensure that their product contains Supplement Facts labels containing nutrition information which includes the size of the serving and the total number of servings in the container, (iii) a list containing all dietary ingredients and their amount per serving in the product and finally (iv) the place of business of the manufacturer or distributor. The 1994 Dietary Supplement Health and Education Act also makes it illegal for companies producing dietary supplements and ingredients (and their distributors) to market adulterated or misbranded products, meaning that companies themselves are responsible for evaluating the safety and labelling of their products and ensure they meet all FDA requirements before selling them to the public. You should also expect to see a statement on the front label of the product identifying it as a “dietary supplement” or a similar description such as “a calcium supplement”. And on the subject of labels, there is one last thing you should be aware of relating to expiration dates. Companies are not required to put expiration dates on their dietary supplements. However, if a company does choose to place an expiration date on their product, they are required to have experimentally valid data demonstrating that the date is not misleading.
Once on the market, the FDA will ensure labelling requirements are met and periodically inspect the manufacturing facilities
You should also know that companies are not required to convey their intent of bringing a new supplement to the market to the FDA. But once on the market, the FDA will ensure labelling requirements are met (not only on the physical product but on the company website as well to confirm that no claims are made on the products ability to prevent or cure diseases, which would lead to a reclassification of the product as a drug). The FDA will also periodically inspect the manufacturing facilities and closely monitor reports of side effects or other adverse events submitted by the company itself, customers, or health care professionals to keep up to date on the safety profile of the supplement. If a product is found to be unsafe, there are several possible responses from the FDA – they can assist the company with bringing the supplement back into compliance, they can ask the manufacturer to recall the product, or impose the removal of the product from all forms of sale. With this knowledge you may have more of an idea of why it is important to report an adverse effect with a supplement if you think you may have experienced such. Without submission of this information, there is not much the FDA can act upon to rectify the situation.
A high source of an ingredient means it is present to at least 20% of the Daily Value (DV).
Now back to claims that can be placed on a label. All of the finer details of the types of claims that can be put on dietary supplement labels have been provided by the FDA. But we will provide some of the highlights here for you. For example, have you ever considered what is meant when a supplement claims it is a high or a good source of a certain ingredient? What exactly is meant by high? Well, high means the ingredient is present in the formulation to at least 20% of the Daily Value (DV). A good source means it will be there at levels between 10% and 19% of the DV. However, a fair number of ingredients found in supplement do not have a DV, perhaps because there is still insufficient available information about them. In this case, the manufacturer can only say it is there, and cannot suggest that it is a “good” or “high” source of that ingredient.
Structure/Function claims such as “Calcium will build strong bones” do not require FDA preapproval
Now let’s examine the subtle difference between health claims and another form of claim known as a structure/function claim. A health claim is a specific or implied existence of a relationship between a compound and a health-related condition or disease. An example of such a claim would be “This supplement will cure your acne”. Such a claim requires extensive scientific evaluation by the FDA and their authorization must be obtained prior to its use. On the other hand, structure/function claims describe an intended role of a substance to maintain the function or structure of the body. Examples are “Calcium will build strong bones” or “Antioxidants help maintain cell integrity”. These structure/function claims do not require FDA preapproval. However, in some cases, they can appear to be very similar to a health claim where they claim a benefit related to a specific nutrient deficiency disease but must also disclose the prevalence of that disease in the USA. An example of such a claim, in this case, would be something like “Vitamin C will help prevent scurvy”. When using structure/function claims, the manufacturer must have evidence that all claims are true and not misleading, include a disclaimer and notify the FDA. The disclaimer must read, "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.
To sum up, our goal in this article was to inform you of five things you may not have known about dietary supplements, and we hopefully provided that and more. Unlike drugs, dietary supplements do not require FDA approval and the meticulous and thorough safety and scientific evaluations involved in that process. The FDA only regulates the supplement industry with specific rules pertaining to information provided on supplement labels and claims that can be made. Knowledge of these regulations and facts can help you spot a bogus manufacturer that should be avoided and help you settle on the supplement that is best for you.
Anna Misztela, Executive Contributor Brainz Magazine
Anna Misztela’s interest in nutrition analysis and beauty began after she won the Mrs Polonia 2017 and Mrs Polonia World 2018 beauty contests. She then completed a Nutrition Science certification and became a Board-Licensed Esthetician. Her goal was to unlock the mystery of naturally beautiful hair, skin and nails. She was astonished by her discoveries of how sulfur and different types of vitamins work in our body. Since Roman times sulfur baths and sulfur waters have had known health and beauty benefits. Anna has included these compounds in her unique product, which helped many women to transform their hair, improve skin conditions, and get stronger nails. That’s how Beauty&Cutie was born.
