FDA pre-market approval may not be necessary for a dietary supplement sale in the United States. But that does not mean it can be marketed without following proper regulations. Manufacturers and distributors have to ensure that supplements are safe and properly manufactured. Their labels need to have completely accurate info, and marketing should make lawful claims.
This guide provides a comprehensive outlook on US dietary supplement regulations under US FDA requirements. From definition to import requirements, there’s everything.
US Regulatory Body for Dietary Supplements
FDA regulates dietary supplements. It does so under the Federal Food, Drug, and Cosmetic Act, as amended by the Dietary Supplement Health and Education Act of 1994 (DSHEA). Dietary supplements are regulated as a category of food. There are specific statutory provisions for their labels, import, etc.
The FDA gives no approval to dietary supplements or their labels before marketing. The company responsible has to ensure the product’s adherence to the law. FDA can inspect facilities and review required submissions. They can investigate safety issues and enforce action against products or firms that violate regulatory requirements.
What Is a Dietary Supplement?
The FD&C Act defines it in the US. A dietary supplement aims to supplement the diet. It contains one or more dietary ingredients. These may include dietary substances used to increase total dietary intake as well as the following:
- Vitamins
- Minerals
- Herbs or other botanicals
- Amino acids
- Concentrates
- Metabolites
- Constituents
- Extracts
- These ingredient combinations
These supplements are for ingestion. Consumers may eat them in tablets, capsules, softgels, powders, or liquid forms. The label needs to clearly write dietary supplement. Or they must use an equivalent term that recognizes the dietary ingredient. That covers “vitamin supplement” or “herbal supplement.”
The ingredients put into the product and their intended use, presentation, and claims help know its regulatory category. Claims of a product for diagnosis, treatment, cure, or prevention of a disease may have to follow drug regulations instead of dietary supplement.
Dietary Supplement Facility Registration in the US
Facilities that manufacture, process, pack, or hold dietary supplements for consumption in the United States must register with the FDA. That is, unless an exemption applies. This includes qualifying domestic and foreign facilities handling dietary supplements for the US market. Facility registration is not product approval, certification, or confirmation that a supplement adheres to FDA requirements.
Information Needed for Registration
The FDA’s registration system requests facility and contact information. This includes the following:
- Facility name, address, and contact details
- The owner, operator, or agent in charge
- A US agent for a foreign facility
- The applicable food product category and facility activity information requested by the FDA
Facilities must renew registration during the biennial renewal period in even-numbered years. They must also update registration information when required, including when information changes or the facility ceases operations.
US FDA Dietary Supplement Labeling Requirements
Dietary supplement labels must only state the truth. Nothing should mislead. The main labeling elements are the following:
- Statement of identity: The product name and the words “dietary supplement,” or an equivalent term identifying the dietary ingredient
- Net quantity of contents: The amount of product in the package
- Supplement Facts panel: Required nutrition labeling. It’s subject to specific exemptions
- Serving information: Serving size and servings per container
- Dietary ingredients: Required declarations and amounts. Rules for proprietary blends and other specific cases may apply
- Other ingredients: Ingredients not declared in the Supplement Facts panel. These are excipients, flavors, or capsule materials
- Name and business place. Of the manufacturer, packer, or distributor on the label
- Serious adverse event contact: A domestic address or domestic phone number to report something gone wrong
The Supplement Facts panel must declare each dietary ingredient as well as the amount per serving. Exceptions are applicable to ingredients that are part of a proprietary blend. The amount must be stated by weight according to the ingredient. It can also be a percentage of Daily Value. Some small-volume products and products that eligible small businesses make may qualify for exemptions from some nutrition-labeling needs. A company should verify this beforehand.
Regulations for Dietary Supplement Claims in the US
Honest, not deviating, and supported by substantiation claims are the only ones permitted. Drug regulations may apply to those claims that show it diagnoses, reduces, treats, cures, or prevents a disease.
Structure/Function, General Well-Being & Deficiency-Disease Claims
The FDA requires notification of labels and specific claims dietary supplement companies make. Check them below:
| Claims | Description |
| Structure/Functional Claims |
Describe the nutrient or dietary ingredient’s role. Tells its effect on or maintenance of body structure or function
|
| General Well-Being Claims |
Describes general health benefits from consuming a nutrient or dietary ingredient
|
| Classical Nutrient Deficiency Disease Claims |
Benefit related to it and disclose the disease’s prevalence in the United States
|
These claims require the label to have the following statutory disclaimer in boldface type:
“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.”
Putting the disclaimer does not make an otherwise unlawful disease claim acceptable. Other claim categories, like health claims and nutrient content claims, have separate requirements. Some also require their own FDA submission.
New Dietary Ingredient (NDI) Notification Requirements & Process
A manufacturer or distributor must submit a NDI notification. They must do so when they want to market a dietary supplement having an NDI, unless an exception applies. An NDI is a dietary ingredient. It was not marketed in the States prior to October 15, 1994.
When the ingredient is in the food supply, the requirement of a notification becomes meaningless. It should be as an article used for food in a form in which the food has not been chemically altered. It comes under the statutory food-supply exception. Submit the notification at least 75 days before the NDI is introduced or delivered for introduction into interstate commerce. It is a premarket safety notification. It doesn’t get you any approval.
Information and Documents for an NDI Notification
The information required by law and regulation for the notification is given below:
- Notifier’s name and complete address
- NDI identity: The ingredient’s name; for an herb or other botanical, its Latin binomial name, including the author
- Supplement description: The name of each supplement having the NDI and the level of the NDI in each product
- Conditions of use: The conditions stated in the product labeling. Or, if none are stated, the supplement’s ordinary conditions of use
- Safety basis: The history of use or other evidence. It must strengthen the conclusion that the supplement with the NDI will be expected to be safe under the stated conditions of use
- Supporting material: Citations to published articles or other evidence relied on for the safety conclusion. Also, copies of cited published materials
- Translations: An accurate and complete English translation of any submitted material in another language
- Signature: The notifier’s signature or the signature of a person designated by the notifier whom the FDA can contact
FDA gave out an October 2026 guidance. It recommends how manufacturers and distributors should present identity and safety information. The legal submission requirements are in the FD&C Act and 21 CFR 190.6.
NDI Notification Process
The steps are given below:
- Assess the ingredient. Know if it meets the NDI definition and whether the statutory food-supply exception applies.
- Define the supplement and its conditions of use. Look into each product that has the NDI, its NDI level, and the conditions of use stated in the labeling.
- Develop the safety rationale. Assemble the history-of-use information, studies, published literature, and other evidence supporting the safety conclusion under the proposed conditions of use.
- Prepare the notification package. Include the required notifier details, ingredient identity, product description, conditions of use, safety information, supporting materials, translations where needed, and signature.
- Submit to FDA at least 75 days before marketing. FDA provides the Centralized Online Submission Module (COSM). It is for electronic submissions.
- Wait through the statutory period. Do not introduce or deliver the supplement having the NDI into interstate commerce during the 75 days after FDA receives the notification.
- Respond to FDA inquiries. Retain records. If the FDA determines that additional information is a substantive amendment, the filing date and therefore the 75-day period may restart.
FDA’s lack of objection or lack of a response does not mean that FDA has found the ingredient or supplement safe or determined that the product is up-to-date with all legal requirements.
Structure/Function and Related Claim Notification Requirements & Process
The notification to the FDA should be given by the manufacturer, packer, or distributor. They should do so when marketing a dietary supplement with any type of claim. Submit the notification within 30 days. Especially after the supplement is first marketed with the claim. This is a postmarket notification, unlike the 75-day premarket NDI notification.
Information and Documents for the Claim Notification
The notification must include the following:
- Manufacturer, packer, or distributor’s name & address
- Precise text of the claim as it is on the label or in the labeling
- The name of the dietary ingredient or supplement that is the subject of the claim
- Each dietary supplement’s name that bears the claim, including its brand name. Each product and brand must be identified. A generic phrase such as “other products” is not sufficient.
- The signature of a responsible individual. Certify that the info is full and correct. Also, the firm has substantiation showing the claim is correct and not deceptive.
Claim Notification Submission Process
Follow the steps below:
- Classify the claim. Know if it is a structure/function, general well-being, or qualifying deficiency-disease claim.
- Review the words. The claim should not state or imply that the supplement diagnoses, reduces, treats, cures, or prevents a disease.
- Confirm substantiation. Honest and non-misleading claims.
- Identify all products using the claim. Record the exact claim text. Also, the product and brand names for each supplement carrying it.
- Prepare and sign the notification. Have the required company information, claim text, ingredient or supplement identification, product names, and responsible individual’s certification in it.
- Submit the notification within 30 days after first marketing with the specific claim. FDA accepts electronic submissions through COSM and written submissions under its current instructions.
- Retain the filing and monitor correspondence. The FDA may send a courtesy letter if it objects to a claim. FDA does not necessarily send a response when it has no objection, and a response—or no response—is not an all-clear for the product’s overall compliance.
Dietary Supplement Manufacturing and CGMP Requirements in the US
Current good manufacturing practice (CGMP) requirements must be followed by dietary supplement manufacturers. They are in 21 CFR Part 111. These requirements cover manufacturing, packaging, labeling, and holding of dietary supplements. The rules address the following:
- Quality-control operations
- Specifications
- Component and product testing or examination
- Production & packaging control
- Recordkeeping
Companies must set up identity, purity, strength, and composition details. It should also have limits on contaminants and decide whether those specifications are met.
Importing Dietary Supplements into the United States
FDA requirements should be met for importing dietary supplements. They do not generally approve or certify individual supplement products or importers before shipment. Before importing, companies should confirm the following:
- Foreign facility registration with the FDA where it is required
- Supplement’s labeling meeting US dietary supplement requirements
- Submission of any required NDI notification and the 75-day period elapsing
- Claims on the supplement’s label or labeling meeting the applicable claim rules, including any required notification
- Importer determining which import requirements apply to the shipment and has completed the required entry filings
The FDA may examine imported supplements, request information, or refuse admission when a product seems to violate US requirements. Importers should also check whether product-specific requirements apply to their supplement and shipment.
US FDA Oversight and Compliance Records for Dietary Supplements
The FDA may inspect dietary supplement facilities. They may review required notifications and investigate adverse event reports. Based on that, enforcement action may be taken for violations. FDA may issue warning letters, detain or refuse imported products, or take other regulatory measures according to the circumstances.
Companies should maintain organized records for the following:
- Facility registration
- Product formulations
- Ingredient specifications
- Manufacturing and quality controls
- Labels
- Claims substantiation
- NDI notifications
- Claim notifications
- Import activities
Keep submission receipts and FDA correspondence with the product’s regulatory records.
Dietary supplement requirements and FDA guidance can update from time to time. Regulatory teams need a process to be on top of updates that may affect ingredients, claims, labeling, manufacturing controls, or import procedures. Artixio’s QuriousRI can support regulatory intelligence and monitoring by helping teams track regulatory information and assess potential compliance impacts.
Conclusion
Adherence to the FDA dietary supplement regulations requires following several duties. Companies need to confirm that a product qualifies as a dietary supplement. They should maintain compliant labeling and manufacturing controls. Required notifications should also be completed on time within the correct timelines. Keeping the evidence, submissions, labels, and FDA correspondence organized is important. It helps companies manage these responsibilities throughout the product lifecycle.
Let Artixio’s US regulatory experts help you manage the regulatory requirements and compliance process. Connect with us at info@artixio.com to learn more.
FAQs
1. Does the FDA approve dietary supplements before they are sold?
No. FDA does not approve dietary supplements or their labels before marketing. Companies are responsible for ensuring that their products comply with the law. Required NDI and claim notifications are not general product approvals.
2. Does the FDA’s silence mean it has accepted an NDI notification?
No. FDA’s lack of a response does not mean the agency has found the NDI or supplement safe or determined that it is not adulterated. A notification does not replace the company’s responsibility to comply with all applicable legal requirements.
3. Does every dietary supplement claim need a 30-day notification?
No. The 30-day notification applies to structure/function claims, general well-being claims, and qualifying classical nutrient deficiency disease claims under section 403(r)(6). Other claim types have separate rules, and some require a different FDA petition or notification.
