Does FDA approve dietary supplements before they are sold?

No. FDA does not approve dietary supplements or their labels before they reach the market. The company that markets the product is responsible for making sure it is safe, properly labeled, and supported by evidence for any claims.

What is the difference between a dietary supplement consultant and a supplement attorney?

A consultant can review labels and formulas, but cannot give legal advice or protect your communications with attorney-client privilege. A supplement attorney provides the same practical review plus legal risk analysis, and can represent you if FDA, the FTC, a retailer or a plaintiff challenges your product.

Do I need to file a New Dietary Ingredient notification?

If your product contains a dietary ingredient that was not marketed in the United States before October 15, 1994, and it has not been present in the food supply in a chemically unaltered form, you generally must submit an NDI notification to FDA at least 75 days before marketing.

What is the 30-day structure/function claim notification?

If your supplement makes a structure/function claim, such as supports joint health, you must notify FDA no later than 30 days after first marketing the product with that claim. The label must also carry the required FDA disclaimer.

Can my supplement say it treats or prevents a disease?

No. A claim that a supplement diagnoses, treats, cures, mitigates or prevents a disease makes the product an unapproved drug under FDA law. This includes implied claims made through images, testimonials, hashtags and product names.

Do supplement companies have to follow cGMP rules?

Yes. Companies that manufacture, package, label or hold dietary supplements must follow the current good manufacturing practice rules at 21 CFR Part 111. Brand owners that use contract manufacturers remain responsible for product quality.

How much does a supplement label review cost?

Cost depends on the number of products and the scope of review. Many label, ingredient and website reviews are offered on a flat-fee basis so you know the cost before work begins.

Dietary Supplement Consultant and Attorney Services

Who it’s for	Supplement brands, private label and white label sellers, Amazon and DTC sellers, contract manufacturers, ingredient suppliers, importers, and startups launching a first product
What’s covered	Ingredient reviews, NDI notifications, Supplement Facts panels, label and packaging reviews, claims and website reviews, structure/function notifications, cGMP guidance, FDA enforcement responses
Legal basis	Dietary Supplement Health and Education Act of 1994 (DSHEA), the FD&C Act, 21 CFR 101.36 (Supplement Facts), 21 CFR 101.93 (structure/function claims), 21 CFR Part 111 (cGMP)
Who reviews it	A licensed FDA regulatory attorney, not a general consultant
Why it matters	FDA does not approve supplements before sale. The brand owner carries full responsibility for safety, labeling and claims.

What Do Dietary Supplement Consultant and Attorney Services Include?

Dietary supplement consultant and attorney services help supplement companies bring products to market that meet FDA and FTC requirements. The work covers what goes into the product, what the label says, what the marketing claims, and how the product is manufactured.

Many supplement brands rely on a contract manufacturer, a label designer, or a competitor’s packaging for guidance. None of those sources take legal responsibility for the result. When FDA sends a Warning Letter or Amazon removes a listing, the brand owner deals with the consequences.

Our firm handles supplement compliance through a licensed attorney. You get the hands-on product review a supplement consultant offers, along with legal analysis of your risk and privileged advice if a regulator, retailer or plaintiff questions your product.

Why Supplement Compliance Matters

Supplements sit in a unique place in FDA law. They do not need premarket approval, but they are held to strict rules on ingredients, labeling and claims. A product that crosses those lines can be treated as an adulterated supplement, a misbranded product, or an unapproved new drug. That can lead to:

FDA Warning Letters published on FDA’s website
FTC action over health claims that lack competent and reliable scientific evidence
Amazon and retailer delistings, which often require compliance documentation to restore
Import detentions and placement on an Import Alert
Recalls, seizures and injunctions for unsafe or illegal ingredients
Consumer class actions targeting “clinically proven,” “natural,” or efficacy claims

A legal review before launch costs far less than relabeling inventory or responding to enforcement.

Launching a new supplement or reformulating an existing one? Have an FDA attorney review your formula and label before you place a production order.

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What We Review, by Supplement Business Type

Business Type	Key Regulations	What We Focus On
Supplement brands and startups	DSHEA; 21 CFR 101.36; 21 CFR 101.93	Ingredient legality, Supplement Facts panel, statement of identity, claims and required disclaimers
Amazon and DTC sellers	FD&C Act; FTC Act	Listing copy, product images, reviews and testimonials, compliance documentation for marketplace reinstatement
Private and white label sellers	21 CFR Part 111; 21 CFR 101.5	Manufacturer agreements, “distributed by” statements, specification and quality responsibilities
Contract manufacturers	21 CFR Part 111 (cGMP)	Specifications, identity testing, batch records, complaint and adverse event handling
Ingredient suppliers	FD&C Act § 413; 21 CFR 190.6	New Dietary Ingredient status, NDI notifications, GRAS positions, drug exclusion analysis
Importers	21 CFR Part 1 (Prior Notice, FSVP)	Foreign label compliance, entry documentation, import detentions and alerts

What’s Included in Our Supplement Services

Ingredient review to confirm each ingredient is a lawful dietary ingredient and is not excluded as a drug
New Dietary Ingredient analysis and preparation of NDI notifications when required
Supplement Facts panel review for serving size, dietary ingredient order, units, % Daily Value, proprietary blends and “Other ingredients”
Label and outer packaging review for statement of identity, net quantity, allergen declarations, and manufacturer or distributor information
Claims review of structure/function, nutrient content, health, “natural” and “organic” claims
Website and social media review, including testimonials, influencer content, and Amazon listings
Structure/function claim notifications filed with FDA within 30 days of marketing
cGMP guidance for brand owners and manufacturers under 21 CFR Part 111
Enforcement response to Warning Letters, Form 483 observations, import detentions and marketplace suspensions
A written compliance memo explaining each issue, why it matters, and the specific fix

Core Service Areas

Dietary Supplement Ingredient Reviews

Products are regulated based on their ingredients and intended use. Some ingredients may only be used in products classified as drugs, and others require an NDI notification before they can be sold. Under the drug exclusion provision of the FD&C Act, an ingredient first approved or substantially investigated as a drug generally cannot later be sold as a supplement. We review each ingredient in your formula, flag regulatory risk, and advise whether to proceed, file a notification, or reformulate. Learn more about ingredient reviews.

New Dietary Ingredient (NDI) Notifications

A dietary ingredient that was not marketed in the U.S. before October 15, 1994 is generally considered a New Dietary Ingredient. Unless it has been present in the food supply in a chemically unaltered form, the manufacturer or distributor must submit an NDI notification with safety information to FDA at least 75 days before the product is marketed. We assess NDI status, organize the safety evidence, and prepare the submission.

Supplement Facts Panels and Label Reviews

FDA sets strict rules on placement, formatting and required statements for supplement labels. The principal display panel must identify the product as a dietary supplement, and the Supplement Facts panel must follow 21 CFR 101.36 for serving size, units, Daily Values and proprietary blends. Ingredients must be declared by their common or usual name. We give you marked corrections your designer can apply directly. Learn more about label reviews.

Structure/Function, Health and Disease Claims

Supplements may make structure/function claims, such as “supports healthy joints,” if the claim is truthful, supported by evidence, and carries the required FDA disclaimer. FDA must be notified within 30 days of first marketing the claim. Any statement that a product diagnoses, treats, cures, mitigates or prevents a disease turns it into an unapproved drug. That includes implied claims through product names, images, hashtags and customer reviews you share. We review claims across packaging, websites, Amazon listings and social media.

Marketing and FTC Substantiation

FDA regulates the label, while the FTC oversees advertising. The FTC expects health claims to be backed by competent and reliable scientific evidence, generally high-quality human clinical studies. We evaluate your substantiation, identify claims that overstate the evidence, and suggest compliant alternatives that still sell.

cGMP, Adverse Events and Enforcement

Supplement companies must follow current good manufacturing practices at 21 CFR Part 111, and brand owners remain responsible even when using a contract manufacturer. Companies must also report serious adverse events to FDA within 15 business days. When FDA issues a Form 483, Warning Letter or import detention, we prepare a timely response and corrective action plan. Learn more about Warning Letter responses.

Our Supplement Compliance Process

Submit your materials: formulas, specifications, labels, website links, or FDA correspondence
Attorney review: analysis against DSHEA, FDA regulations, FTC standards and current guidance
Findings report: a clear written memo listing each issue by risk level with the required correction
Revision support: we review updated labels and copy until they are compliant
Ongoing counsel: available for new SKUs, reformulations, filings and FDA inquiries

Most label and ingredient reviews are completed within five to seven business days. Rush timelines are available.

Why Work With a Supplement Attorney Instead of a Consultant

Many brands search for a dietary supplement consultant and never consider a lawyer. The difference shows up when something goes wrong.

Attorney-client privilege. Your communications with an attorney are generally privileged. A consultant’s notes and emails can be requested in litigation or an FDA investigation.
Legal risk analysis. We weigh FDA and FTC exposure alongside competitor challenges and consumer class actions.
Enforcement representation. If FDA, the FTC or a marketplace acts against your product, your attorney already knows it and can respond right away.
One point of contact. Formulation questions, manufacturer contracts, filings and enforcement defense are handled by the same counsel.

Frequently Asked Questions

Does FDA approve dietary supplements before they are sold?: No. FDA does not approve dietary supplements or their labels before they reach the market. The company that markets the product is responsible for making sure it is safe, properly labeled, and supported by evidence for any claims.
What is the difference between a dietary supplement consultant and a supplement attorney?: A consultant can review labels and formulas, but cannot give legal advice or protect your communications with attorney-client privilege. A supplement attorney provides the same practical review plus legal risk analysis, and can represent you if FDA, the FTC, a retailer or a plaintiff challenges your product.
Do I need to file a New Dietary Ingredient notification?: If your product contains a dietary ingredient that was not marketed in the United States before October 15, 1994, and it has not been present in the food supply in a chemically unaltered form, you generally must submit an NDI notification to FDA at least 75 days before marketing.
What is the 30-day structure/function claim notification?: If your supplement makes a structure/function claim, such as “supports joint health,” you must notify FDA no later than 30 days after first marketing the product with that claim. The label must also carry the required FDA disclaimer.
Can my supplement say it treats or prevents a disease?: No. A claim that a supplement diagnoses, treats, cures, mitigates or prevents a disease makes the product an unapproved drug under FDA law. This includes implied claims made through images, testimonials, hashtags and product names.
Why can some ingredients not be sold as supplements?: Under the drug exclusion provision of the FD&C Act, an ingredient first approved or substantially investigated as a drug generally cannot later be marketed as a dietary supplement unless it was marketed as a supplement or food first.
Do supplement companies have to follow cGMP rules?: Yes. Companies that manufacture, package, label or hold dietary supplements must follow the current good manufacturing practice rules at 21 CFR Part 111. Brand owners that use contract manufacturers remain responsible for product quality.
How much does a supplement label review cost?: Cost depends on the number of products and the scope of review. Many label, ingredient and website reviews are offered on a flat-fee basis so you know the cost before work begins.

Not sure if your supplement is compliant? Our attorney will review your product and give you a clear answer.

Toll-free: (866) 785-0873

Direct: (305) 507-9843

Email: contact@giannamore-law.com