In recent years, the US supplement industry has grown significantly, with consumers increasingly seeking products to support their health and wellness. This growth has led to an increasing focus on meeting regulatory requirements.
Supplement labelling and marketing in the United States are subject to strict regulation to ensure safety, accuracy and prevent misleading claims.
It’s essential that you’re on top of current US regulations for the labelling of supplements and ensure you meet all necessary requirements. We’ll provide a comprehensive overview of up-to-date frameworks to ensure that you’re making compliant health claims on dietary supplement labels in US.
Regulatory framework for supplements in US
The primary regulatory body overseeing dietary supplements in the United States is the US Food and Drug Administration (FDA), which enforces the Dietary Supplement Health and Education Act (DSHEA) of 1994.
While dietary supplements are regulated more like food than drugs, they are distinct from both categories. They include vitamins, minerals, amino acids, botanicals, herbs, enzymes and other substances.
Under DSHEA, supplements are not required to undergo the rigorous pre-market approval process that drugs face. However, manufacturers must follow strict guidelines to ensure safety and proper labelling.
DSHEA gives the FDA the right to take action against any ‘adulterated or misbranded dietary supplement product’ – even after it reaches the market.
Key points in the DSHEA
This act defines what constitutes a dietary supplement, regulates labelling and marketing and stipulates guidelines on how companies can make claims about the benefits of their products.
Below are the key regulations you need to know for UA supplement labelling.
Pre-market notification
Supplements do not require FDA approval before marketing.
However, for supplements that contain a new dietary ingredient (NDI) – one not marketed in US before 1994 – the manufacturer must notify the FDA 75 days before the product is introduced. This notification must include information on how the ingredient is expected to be safe.
You can see more on what constitutes a ‘dietary ingredient’ per the DSHEA below.
Good Manufacturing Practices (GMPs)
The FDA enforces Current Good Manufacturing Practices (CGMPs) for dietary supplements, which outline specific standards for processing, packaging and labelling to ensure product safety and quality. Noncompliance with CGMPs can result in product recalls or enforcement actions by the FDA.
Adverse event reporting
Supplement manufacturers are required to report serious ‘adverse events’ to the FDA. Consumers and health professionals can also report these events directly to the agency, which monitors safety post-market.
Labelling oversight
The FDA mandates certain information to appear on supplement labels to inform consumers, prevent misleading information and ensure compliance with labelling requirements.
The Federal Trade Commission (FTC) also plays a key role in regulating marketing claims to ensure advertising is truthful and not deceptive.
What information must be included on supplement labels in US?
A dietary supplement label must contain several specific elements to comply with US regulations:
- Statement of identity: The label must clearly state the identity of the product as a dietary supplement. This can be done by including a term like ‘dietary supplement’, ‘vitamin supplement’ or ‘herbal supplement’ prominently on the label.
- Net quantity of contents: The front of the package must display the total amount of product contained within (e.g., ‘100 capsules’).
- Nutrition labelling (Supplement Facts panel): The Supplement Facts label is one of the most critical requirements for US supplements labelling. It must list each ingredient, including the serving size, number of servings per container and the quantity of each ingredient or nutrient per serving. If a nutrient has an established Daily Value (DV), the amount per serving and percentage of DV must be included.
- Ingredient list: In addition to listing ingredients in the Supplement Facts panel, non-dietary ingredients like fillers, binders, flavourings or colour additives must be listed separately, usually under an ‘Other Ingredients’ heading.
- Name and place of business: The label must provide the name and location (city, state and zip/postcode) of the manufacturer, packer or distributor.
- Directions for use: Suggested use instructions should be included, specifying how much and how often the product should be consumed.
- Disclaimer statement: If a product includes a structure/function claim (e.g., ‘supports immune health’), it must also include the disclaimer: ‘This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.’ You can see more on avoiding disease claims in your supplement labelling below.
Approved ingredients for US supplements
The ingredients used in US supplements fall into several categories, with the FDA closely regulating what can and cannot be included.
Established ingredients
The FDA maintains a list of ingredients recognized as safe, many of which were in common use before DSHEA’s enactment in 1994.
These ingredients do not require pre-market approval or notification, as they are considered safe based on historical use. They include: vitamins and minerals, herbs and other botanicals, amino acids and ‘dietary substances’ that are already part of the food supply (such as probiotics).
New dietary ingredients (NDIs)
For ingredients introduced after 1994, manufacturers must submit an NDI notification to the FDA, including evidence that the ingredient is reasonably expected to be safe for use.
This submission process can be rigorous and failure to notify the FDA may result in enforcement actions.
GRAS ingredients
Some ingredients are designated as Generally Recognized As Safe (GRAS), meaning experts agree that they are safe under the conditions of their intended use.
GRAS substances are typically used in food products but may also be present in dietary supplements.
Prohibited ingredients
Certain ingredients have been banned by the FDA for use in supplements due to safety concerns.
For example, supplements containing ephedrine alkaloids (ephedra) were banned in the US in 2004 following reports of severe cardiovascular events and deaths linked to its use in weight-loss products.
Making compliant health claims
One of the most challenging areas of supplement labelling is making health claims that are compliant with FDA and FTC regulations.
Compliant health claims on supplement labels can take several forms:
Structure/function claims
These claims describe the role of a nutrient or ingredient in affecting normal body structure or function.
Statements like ‘calcium builds strong bones’ or ‘fibre supports digestive health’ are common structure/function claims.
These claims do not need pre-market approval but must be truthful and not misleading. They also require the FDA disclaimer mentioned earlier (under ‘disclaimer statement’).
Health claims
A health claim explicitly states a relationship between a substance and a reduced risk of a disease or health condition.
Health claims can include statements such as ‘adequate calcium may reduce the risk of osteoporosis if consumed as part of a well-balanced diet’.
Health claims require significant scientific agreement and must be pre-approved by the FDA. Approved health claims are based on substantial scientific evidence supporting the relationship.
Qualified health claims
If the scientific evidence for a health claim is emerging but not conclusive, the FDA may allow a qualified health claim.
These claims must be carefully worded to convey the limitations of the evidence.
Statements such as ‘some scientific evidence suggests that consuming green tea may reduce the risk of certain cancers, although the FDA has concluded that this evidence is limited and not conclusive’ would count as a qualified health claim.
Nutrient content claims
These claims describe the level of a nutrient in a product (e.g., ‘high in vitamin C’ or ‘low fat’).
Nutrient content claims are only allowed for nutrients with an established DV (Daily Value) and must meet specific FDA criteria.
Avoiding disease claims
One of the most critical rules for US supplement labelling is avoiding disease claims, which would classify the product as a drug under FDA regulations.
Claims like ‘treats arthritis’ or ‘cures heart disease’ are strictly prohibited for dietary supplements, as they suggest that the product is intended to treat, cure or prevent a disease.
Enforcement and penalties for non-compliance
Failure to comply with FDA and FTC regulations can result in significant consequences, including product seizures, injunctions and fines.
Both agencies routinely monitor supplement labelling and advertising to ensure compliance.
Noncompliant companies can face warning letters, legal action and even criminal prosecution in cases of egregious violations.
Remaining compliant for US supplement labelling
The US dietary supplement industry is heavily regulated. Understanding the rules surrounding labelling, approved ingredients and health claims is crucial for manufacturers and marketers.
Always adhere to FDA and FTC guidelines to ensure that your products are safe, accurately labelled and marketed in a way that complies with the law.
Remaining regulation compliant not only protects consumers but will also build trust in your brand as well as the industry as a whole.
