What are Dietary Supplements: 

Dietary supplements are additions to the standard diet which are quite distinct from the ingredients found in conventional foods. The use of dietary supplements has witnessed an upsurge in mass consumption over the past several years, as many people have made staying healthy and active a priority. These supplements are not intended to treat, identify, prevent, or cure any ailments; rather they are meant to complement the diet with specific dietary elements. They are usually imbibed into many forms such as tablets, capsules, gel caps, soft gels, bars, gummies, powders, and liquids. Vitamins (such as multivitamins or specific vitamins like vitamin D and biotin), minerals (such as calcium, magnesium, and iron), botanicals or herbs (such as echinacea and ginger), botanical compounds (such as caffeine and curcumin), amino acids (such as tryptophan and glutamine), and live microbial (sometimes known as “probiotics”) are the most popular supplements available on the market. Dietary Supplements come in with added benefits to humans; they serve different aspects of meeting the intended use. 

Benefits and Usage of Dietary Supplements: 

Dietary supplements are available in numerous forms, and they help in regaining adequate essential nutrients, which regulate the body’s metabolism, providing additional strength to the immune system contributing to general well-being. Those who are allergic to specific foods (e.g. lactose intolerant)  perceive dietary supplements as having additional benefits. Pregnant women are prescribed these supplements to prevent birth abnormalities. Elderly people are advised to take them for strengthening bones and rejuvenating the function of nerves and red blood cell count. They are also widely used by athletes in boosting their nutritional intake and performance.

Federal laws governing dietary supplements: 

These dietary supplements should indeed adhere to specific regulations considering their benefits and widespread consumption. In 1994, The Dietary Supplement Health and Education Act (DSHEA) was enacted altering the Federal Food, Drug, and Cosmetic Act (FD&C Act) to be the official authorizer of such products by determining the regulatory framework & coined the term “dietary supplement”. The regulatory framework for dietary supplements differs from that of a drug. They need not have to provide any evidence or seek approval before the product hits the market. It is the prime duty and responsibility of the manufacturers/companies to conform to the safety standards of dietary supplements without violating FDA regulations. The manufacturer is accountable for ensuring the dietary supplements are not tampered with or mislabeled. The manufacturers need to abide by the claims such as: 

1. Structure claims which describe the effects on a structure or function of a human body. 
2. Nutrient content claims describe benefits related to the level of nutrients by distinguishing them from other food using terms such as high, low, and free. 
3. Health claims describing the benefits and risk reduction in disease by certain nutrient consumption. 

Also, the label shall include a claim on general well-being, making sure that these claims are not misleading and are in compliance with the regulations. 

Labeling Requirements: 

Since the manufacturers are intended to undertake claims and standards, it is obligatory for them to follow labeling statement requirements as depicted in the flowchart below: 

Dietary supplement labels must include nutrition information in the format of a Supplement Facts label, typically comprising the serving size, the number of servings per container, a list of all dietary ingredients in the product, and the quantity of those elements per serving.

Labels shall be placed on the principal display panel (front label panel) or on the information panel (usually towards the right of the principal display panel, as seen by the consumer). The statement of identity and the net quantity of nutrients will be put forth on the principal display panel (customer-facing) the other requirements will be placed in the information panel. All this information needs to be addressed in the supplements facts panel, other information failing to qualify in the supplements fact panel should be noted as the “other ingredients” list. The label shall bear the accurate address and name of the manufacturer, packager, or distributor to report an adverse event, if any. 

If there is an addition of new dietary ingredients to the list, the manufacturer should notify the FDA in advance by submitting the safety information if it intends to market a dietary supplement in the United States, this notification shall be submitted to the FDA at least 75 days prior to commercializing it in the US market.

The FDA’s role in regulating dietary supplements includes: 

• Inspecting dietary supplement manufacturing facilities, 
• Assessing new dietary ingredient (NDI) notifications and other regulatory filings for dietary supplements, 
• Investigating complaints, 
• Monitoring the dietary supplement marketplace, 
• Examining dietary supplements and dietary ingredients offered for import to verify whether they fulfill U.S. regulations, and 
• Reviewing adverse event reports from businesses, consumers, and consumers’ unions.

The Federal Trade Commission (FTC), which regulates product advertising, also requires supplement marketing materials to be accurate and not deceptive.

FDA has a database known as “Dietary Supplement Fact sheet” which is a collection of fact sheets and other resources from the National Institute of Health (NIH) Office of Dietary Supplements which has information about dietary supplements and their ingredients, this database is available for consumer and other health professionals to look for data related to dietary supplements ingredients, background information, safety, and risk information of that particular ingredient, also these do not classify as drugs for curing, treating any diseases. 

Specific Warnings and Limitations: 

The manufacturer, packagers, and distributors should also pay attention to specific warnings that need to be made available on the packages of these supplements. They should include cautionary statements, meant in terms of adverse effects. If the supplements hold up to any of the three claims that are structure claims, nutrients content claims, and health claims, it’s necessary to include a disclaimer such as “The Food and Drug Administration has not reviewed this statement. The purpose of this product is not to diagnose, treat, cure, or prevent any illness.”

All of these cautions must be stated on the necessary label in a way that alerts customers to these risks.

These supplements are taken by people to ensure that they acquire enough important nutrients and to maintain or enhance their health. Not everyone requires supplements, and some people may respond to them with nausea and vomiting as well as an increased risk of bleeding, particularly if taken before surgery or in combination with other medications. Supplements might also be harmful if you have certain medical issues. Furthermore, the effects of many supplements have not been studied in children, pregnant women (beyond a normal prenatal vitamin), or other populations. As a result, it is advised to take/consume as directed by a physician.

Conclusion: 

For selling dietary supplements in the US market one needs to adhere to the regulation grounds set by FDA and FTC. Even though the FDA does not approve dietary supplements, it enforces the manufacturers, packagers, or distributors to follow regulations by conducting inspections of production and process control systems, import refusals, import alerts, warning letters, suspension of registrations, civil and criminal penalties and tracking the adverse reports that have been reported. 

The safety and quality of dietary supplements rely on the manufacturers, packagers, or distributors’ hands and it is a must that they act in accordance with

• Following Current Good Manufacturing Practice (CGMP)
• Cohesion to Labeling Requirements
• An acquaintance of right claims (Structure claim, Nutrient Content Claims, Health Claims)
• Establishing a master manufacturing record
• Maintaining batch records
• Setting the warnings and limitations to dietary supplements
• Prior notification of “New Ingredient” to FDA. 
• Avoidance of adulteration and Misbranding

When an FDA statute is violated or a product is discovered to be harmful, the FDA can engage with the firm to bring the product into conformity, ask manufacturers, packagers, or distributors to voluntarily recall the product, or take necessary actions to eradicate the harmful product from the market.

Are you a company developing, distributing, manufacturing, packaging, or labeling dietary supplements? You must be aware and be in compliance with the necessary regulations and requirements to avoid any product recalls, suspension of registration, warning letter, or other adverse actions from the regulatory authorities. Contact us today at jennifer@elexes.com to learn more about what requirements are applicable to your dietary supplement and how to comply with it. 

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