Loading...
FDA Registered
Since 2009
500+
Compliant Formulas
500+
Brands Launched
6
Certifications
Foundation
Understanding DSHEA: The Foundation of Supplement Regulation
The Dietary Supplement Health and Education Act (DSHEA), signed into law on October 25, 1994, is the cornerstone of dietary supplement regulation in the United States. It established that dietary supplements are a category of food — not drugs — and set the framework that governs how supplements are manufactured, labeled, and marketed today. Every brand entering the supplement space must understand DSHEA because it defines both your rights and your responsibilities as a manufacturer or brand owner.
What Classifies as a Dietary Supplement?
Under DSHEA, a dietary supplement is a product intended to supplement the diet that contains one or more “dietary ingredients.” These include vitamins, minerals, herbs or botanicals, amino acids, enzymes, organ tissues, glandulars, and metabolites. The product must be intended for ingestion in pill, capsule, tablet, gummy, powder, softgel, gelcap, or liquid form. It must not be represented as a conventional food or as the sole item of a meal or diet, and it must be labeled as a “dietary supplement.”
Manufacturer Responsibilities Under DSHEA
DSHEA places the burden of safety on the manufacturer, not the FDA. This means the entity that manufactures or distributes a dietary supplement is responsible for: ensuring the product is safe before it reaches consumers, ensuring that all label claims are truthful and not misleading, ensuring that the product is manufactured in compliance with cGMP regulations, and submitting serious adverse event reports to the FDA. The FDA does not review or approve dietary supplements before they are sold — but it retains authority to take action against any product that is adulterated, mislabeled, or poses an unreasonable risk of illness or injury.
What DSHEA DOES Require
- Products must be safe for consumption under conditions of use on the label
- Labels must be truthful and not misleading
- Manufacturing must comply with cGMP (21 CFR Part 111)
- Structure/function claims require FDA notification within 30 days
- Serious adverse events must be reported within 15 business days
What DSHEA Does NOT Require
- No pre-market FDA approval or registration of products
- No proof of efficacy before marketing (unlike pharmaceuticals)
- No FDA review of labels before products are sold
- No clinical trials required for dietary ingredients marketed before 1994
- No brand registration (only facility registration is required)
Manufacturing Standards
21 CFR Part 111: cGMP Requirements
Current Good Manufacturing Practices (cGMP) under 21 CFR Part 111 are the FDA's enforceable quality standards for dietary supplement manufacturing. Finalized in 2007 and fully effective since June 2010, these regulations ensure that supplements are produced consistently to identity, purity, strength, and composition standards. cGMP compliance is not optional — it is a legal requirement for every facility that manufactures, packages, labels, or holds dietary supplements sold in the United States.
What cGMP Covers
The regulations are comprehensive, covering every stage of the supplement manufacturing process: from incoming raw material verification to finished product release. cGMP requires written procedures (SOPs) for every manufacturing process, validated analytical methods, calibrated equipment, qualified personnel, controlled environments, and complete documentation trails. The FDA conducts unannounced inspections to verify compliance, and non-compliance can result in warning letters, injunctions, seizures, or criminal prosecution.
Key Compliance Areas
When evaluating a manufacturer, these are the five critical compliance areas you should verify. At Build Your Own Brand, every area is handled in-house with documented protocols and regular third-party audits.
| Area | Requirement | Your Manufacturer Handles |
|---|---|---|
| Production & Process Controls | Written SOPs for every manufacturing process, batch-specific master manufacturing records | |
| Laboratory Testing | Identity testing for all incoming materials; potency, purity, and contaminant testing for finished products | |
| Records & Documentation | Complete batch records, deviation reports, complaint files, retained samples | |
| Facilities & Equipment | Clean, pest-free, temperature-controlled environments; calibrated and validated equipment | |
| Personnel & Training | Qualified personnel with documented training in cGMP procedures and quality systems |
Why this matters for your brand: cGMP violations at your manufacturer become your liability. If a manufacturer receives an FDA warning letter, every brand produced in that facility is potentially affected. Always verify your manufacturer's FDA registration status, request their most recent FDA inspection results (Form 483), and confirm they hold current third-party certifications such as ISO 22000 and HACCP.
Labeling
Supplement Labeling Requirements
FDA labeling regulations for dietary supplements are detailed and prescriptive. Non-compliant labels are the single most common reason for FDA warning letters to supplement companies. Every element — from the Supplement Facts panel format to the placement of the disclaimer — is specified in the regulations. Getting this right is not optional; it protects your brand from regulatory action and builds consumer trust.
What Must Appear on Every Supplement Label
1
Product Name & Identity Statement
The product name must include the words "dietary supplement" to identify the product category. This can appear as part of the name or directly below it.
2
Supplement Facts Panel
A standardized panel listing serving size, servings per container, and each dietary ingredient with its amount per serving and percent Daily Value (%DV) where established.
3
Other Ingredients List
All non-active ingredients (excipients, binders, fillers, flavors, colors, sweeteners) listed in descending order of predominance by weight.
4
Allergen Declarations (Big 9)
Clear identification of the nine major allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. Typically stated as "Contains:" followed by the allergens.
5
Net Quantity Statement
The total count or weight of the product (e.g., "60 Gummies," "120 Capsules," "300g Powder") displayed on the principal display panel.
6
Manufacturer/Distributor Information
The name and place of business (city, state, zip) of the manufacturer, packer, or distributor. If the brand owner is not the manufacturer, "Manufactured for" or "Distributed by" must precede the brand name.
7
Required FDA Disclaimer
If any structure/function claim appears on the label, it must be accompanied by: "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."
Label design service: Our in-house label design service ($250 for up to 3 labels, $120 per additional set of 3) ensures every element meets FDA requirements. We handle Supplement Facts panel formatting, allergen declarations, disclaimer placement, and net quantity positioning — so your label passes regulatory review on the first submission.
Claims & Marketing
Claims: What You Can and Cannot Say
The distinction between permissible structure/function claims and prohibited disease claims is the single most important compliance boundary for supplement brands. Getting this wrong can trigger FDA warning letters, FTC enforcement actions, and potentially product seizures. The line is clear in principle but nuanced in practice — and many new brands cross it unintentionally.
Allowed (Structure/Function Claims)
- “Supports immune health”
- “Promotes healthy digestion”
- “Helps maintain bone strength”
- “Supports cardiovascular function”
- “Contributes to normal energy metabolism”
- “Supports healthy skin and hair”
Prohibited (Drug Claims)
- “Cures diabetes”
- “Treats high blood pressure”
- “Prevents cancer”
- “Reduces cholesterol by 30%”
- “Eliminates arthritis pain”
- “Reverses heart disease”
Substantiation and FTC Oversight
Even permissible structure/function claims must be truthful, not misleading, and substantiated by competent and reliable scientific evidence. The Federal Trade Commission (FTC) has concurrent jurisdiction over supplement advertising and applies the “competent and reliable scientific evidence” standard — meaning you must possess adequate substantiation before making a claim, not after. The FTC has pursued enforcement actions against supplement companies for unsubstantiated claims in online advertising, social media, influencer partnerships, and product packaging.
Additionally, when you make a structure/function claim on your label, you must notify the FDA within 30 days of first marketing the product with that claim. This is a notification, not an approval process — the FDA does not review or approve the claim, but failure to notify is a regulatory violation.
Ingredients
New Dietary Ingredients (NDI)
The NDI notification process is one of the most misunderstood areas of supplement regulation. If your product contains an ingredient that was not marketed as a dietary supplement in the United States before October 15, 1994, you may be required to submit a pre-market safety notification to the FDA. Failure to do so can result in your product being deemed adulterated under federal law.
Pre-1994 vs. Post-1994 Ingredients
Dietary ingredients that were lawfully marketed in the US before October 15, 1994 are considered “grandfathered” or “old dietary ingredients” (ODIs). These include most common vitamins, minerals, amino acids, and well-established herbs. ODIs do not require NDI notification, though they must still comply with all other regulatory requirements including safety, labeling, and cGMP.
Ingredients that entered the market after October 15, 1994 — or ingredients that existed but were not marketed as dietary supplements before that date — are classified as NDIs. These require the manufacturer or distributor to submit a notification to the FDA at least 75 days before introducing the product containing the NDI.
The NDI Notification Process
An NDI notification must include the identity of the new ingredient, the conditions of use (dosage, frequency, duration), and the basis for concluding that the ingredient is reasonably expected to be safe. The evidence may include published scientific literature, toxicological data, history of safe use, human clinical studies, or a combination. The FDA reviews the notification and responds within 75 days, but the notification is not an approval — it is an acknowledgment. If the FDA has concerns, it will send an objection letter outlining the issues.
When NDI Notification Applies
NDI Notification Required
- Ingredient not sold as a dietary supplement before Oct 15, 1994
- New extraction process that changes the chemical composition
- Synthetic version of a naturally occurring ingredient
- Ingredient previously sold only as a conventional food ingredient
NDI Notification NOT Required
- Ingredient marketed as a dietary supplement before Oct 15, 1994
- Ingredient with GRAS status for the specific use in supplements
- Previously notified NDI used under the same conditions
- Ingredient that is a prior-approved food additive
How to check: The FDA maintains a public database of all NDI notifications received since 1994, searchable at FDA.gov > Dietary Supplements > New Dietary Ingredient Notifications. Your manufacturer should be able to confirm the NDI status of every ingredient in your formulation. At Build Your Own Brand, we verify the regulatory status of all ingredients during the formulation development phase — before you invest in production.
Post-Market Obligations
Adverse Event Reporting
Since 2007, the Dietary Supplement and Nonprescription Drug Consumer Protection Act has required supplement manufacturers, packers, and distributors to report serious adverse events to the FDA. This is a non-negotiable legal obligation — not a guideline or recommendation. Understanding your reporting responsibilities is essential for every supplement brand, whether you are a manufacturer or a brand owner selling under your own label.
The 15-Business-Day Reporting Requirement
When a manufacturer, packer, or distributor whose name appears on the product label receives a report of a serious adverse event associated with their supplement, they must submit the report to the FDA within 15 business days. This clock starts from the date the report is received, not the date the event occurred. Follow-up reports with any new medical information received within one year of the initial report must also be submitted within 15 business days.
What Counts as a “Serious” Adverse Event
Death
Life-threatening experience
Inpatient hospitalization
Persistent or significant disability
Congenital anomaly or birth defect
Requires medical intervention to prevent one of the above
Record-Keeping Requirements
Companies must maintain records of all adverse event reports — both serious and non-serious — for a minimum of 6 years. These records must include the original consumer report, any follow-up medical information, the MedWatch report submitted to the FDA (for serious events), and documentation of the investigation and any corrective actions taken. The FDA can request these records during inspections.
MedWatch Reporting
All serious adverse event reports are submitted through the FDA's MedWatch Safety Reporting Program using FDA Form 3500A. Reports can be submitted electronically through the FDA Safety Reporting Portal or by mail. The MedWatch system is also available for voluntary reporting of non-serious adverse events, product quality problems, and product use errors.
Global Markets
International Regulations at a Glance
If you plan to sell your supplement brand internationally, you must comply with the regulatory framework of each target market. Supplement regulations vary dramatically around the world — a product that is fully compliant in the United States may require reformulation, relabeling, or separate registration before it can be legally sold in another country. Here is a high-level comparison of the major markets.
| Market | Regulatory Body | Key Difference from US |
|---|---|---|
| European Union | EFSA | Pre-market notification required. Positive list of permitted ingredients and authorized health claims. Novel Food regulation for new ingredients. |
| United Kingdom | FSA | Post-Brexit separate regime, structurally similar to EU. UK-specific health claims register. Food supplements must be notified to local authority. |
| Canada | Health Canada | Natural Product Number (NPN) required before sale. Products classified as Natural Health Products (NHPs) with mandatory site licensing. |
| Australia | TGA | Listed medicines (lower risk, AUST L) vs Registered medicines (higher risk, AUST R) pathway. Evidence requirements vary by classification. |
| Japan | MHLW / CAA | Foods with Function Claims (FFC) system allows health claims based on manufacturer-submitted evidence. Separate Foods for Specified Health Uses (FOSHU) with government approval. |
Global expertise: We ship to 50+ countries and guide brands through the regulatory requirements for each target market. Our team understands the specific labeling, registration, and ingredient restrictions for the EU, UK, Canada, Australia, Japan, and the Middle East — and we adjust formulations and packaging accordingly before production.
FAQ
Frequently Asked Questions
Do dietary supplements need FDA approval?
No. Under DSHEA (1994), dietary supplements do not require FDA pre-market approval before they are sold. However, the manufacturing facility must be registered with the FDA, and all production must comply with cGMP regulations under 21 CFR Part 111. The manufacturer is responsible for ensuring the product is safe and that label claims are truthful and not misleading. The FDA can take enforcement action against unsafe or mislabeled products after they reach the market.
What is DSHEA?
The Dietary Supplement Health and Education Act (DSHEA) is a 1994 federal law that defines and regulates dietary supplements in the United States. It classifies supplements as a category of food rather than drugs, establishes that manufacturers are responsible for ensuring product safety and accurate labeling, and does not require pre-market approval. DSHEA also allows structure/function claims while prohibiting disease claims.
What is 21 CFR Part 111?
21 CFR Part 111 is the FDA regulation establishing Current Good Manufacturing Practices (cGMP) specifically for dietary supplements. It covers all aspects of supplement production: personnel qualifications, facility and equipment standards, production and process controls, laboratory testing for identity and potency, record-keeping and batch documentation, and handling of consumer complaints. Compliance is mandatory for all supplement manufacturing facilities.
What must be on a supplement label?
Every dietary supplement label must include: the product name with "dietary supplement" identification, a Supplement Facts panel (serving size, amounts, %DV), a complete other ingredients list, allergen declarations for the Big 9 allergens, a net quantity statement, the manufacturer or distributor name and address, and the required FDA disclaimer if any structure/function claims are made.
What claims can I make about supplements?
You may make structure/function claims that describe how a nutrient affects the structure or function of the body (e.g., "supports immune health"). You must NOT make drug claims that state or imply the product diagnoses, treats, cures, or prevents a disease. All claims must be truthful, substantiated, and accompanied by the FDA disclaimer. The FTC also regulates advertising claims.
What is a New Dietary Ingredient (NDI)?
A New Dietary Ingredient (NDI) is any dietary ingredient not marketed in the US before October 15, 1994. Manufacturers must submit a pre-market notification to the FDA at least 75 days before introducing a supplement containing an NDI, with evidence the ingredient is reasonably expected to be safe. Ingredients marketed before that date are grandfathered and do not require notification.
What is adverse event reporting?
Supplement manufacturers, packers, and distributors must report serious adverse events to the FDA within 15 business days. A serious adverse event includes death, hospitalization, persistent disability, birth defects, or events requiring medical intervention. Records must be maintained for 6 years minimum. Reports are submitted through the FDA's MedWatch system.
Do I need to register my supplement brand with the FDA?
You do not need to register your brand with the FDA. However, the manufacturing facility must be registered under the Bioterrorism Act, with renewal every two years. When you work with an FDA-registered manufacturer, this requirement is handled for you. You remain responsible for ensuring your labels and marketing claims comply with FDA and FTC regulations.
What testing is required for dietary supplements?
Under 21 CFR Part 111, manufacturers must test every incoming raw material for identity and test finished products for identity, potency, purity, strength, and composition. Testing must screen for contaminants including heavy metals (lead, mercury, arsenic, cadmium), microbial contamination (E. coli, Salmonella, yeast, mold), and adulterants. A Certificate of Analysis (COA) must be generated for every production batch.
What international regulations apply to supplements?
Regulations vary significantly by market. The EU (EFSA) requires pre-market notification and maintains positive ingredient lists. Canada requires a Natural Product Number (NPN). Australia's TGA uses a listed vs registered medicines pathway. Japan has a Foods with Function Claims system. The UK operates a separate post-Brexit regime. We ship to 50+ countries and guide brands through the regulatory requirements for each target market.
FDA-Registered Manufacturer
Manufacture with Full Regulatory Confidence
Build Your Own Brand is an FDA-registered, cGMP-certified manufacturer with 17+ years of experience navigating supplement regulations across 50+ countries. From formulation compliance to FDA-ready labeling, we handle every regulatory requirement so you can focus on building your brand.
FDA Registered
cGMP Certified
ISO 22000
HACCP
500+ Brands Launched
50+ Countries