Are Supplements Regulated? Understanding FDA Oversight, DSHEA, and Supplement Safety

Jun 18

‍ Most conversations about dietary supplements eventually arrive at the same claim:

"Supplements aren't regulated."

The statement is understandable. Consumers have seen headlines about adulterated products, misleading claims, and questionable companies. Trust has been damaged by bad actors, and skepticism is reasonable.

At the same time, the statement is incomplete.

Dietary supplements are regulated in the United States. However, they are not regulated in the same way as prescription drugs.

Understanding the difference is important because meaningful conversations about safety, quality, and transparency can only happen when everyone starts from the same set of facts.

This article explores what regulation exists today, where the system succeeds, where it falls short, and what improvements could help consumers make better decisions.

The Most Important Distinction: Regulated vs. Pre-Approved

One of the most common sources of confusion is the difference between a product being regulated and a product being pre-approved.

Prescription drugs generally undergo extensive review before reaching the market.

Dietary supplements follow a different regulatory pathway and that distinction often leads consumers to conclude that supplements are "unregulated."

In reality, dietary supplements operate under a framework that includes:

DSHEA framework
FDA oversight
FTC oversight of advertising claims
NAD self-regulatory review
Good Manufacturing Practices (cGMPs)
Labeling requirements
Adverse event reporting
Facility inspections
Warning letters
Product recalls

This framework is why we believe the better description is not that supplements are unregulated but rather that supplements are regulated. They are just regulated differently than pharmaceuticals and much closer to how food and beverage are regulated (different CFR codes though).

CFR stands for Code of Federal Regulations, which is the collection of rules federal agencies use to implement and enforce U.S. laws. When discussing dietary supplements, specific CFR sections outline the requirements manufacturers must follow for product quality, labeling, and safety.

CFR Part 111 vs. CFR Part 117

Most dietary supplement manufacturers operate under 21 CFR Part 111, while conventional food manufacturers typically operate under 21 CFR Part 117.

21 CFR Part 111 (Dietary Supplements)

Specifically written for dietary supplements
Requires identity testing of dietary ingredients
Requires establishment of specifications for identity, purity, strength, and composition
Includes detailed quality control requirements
Requires batch production records and extensive documentation
Generally considered more prescriptive than food GMPs

21 CFR Part 117 (Human Food)

Applies to conventional foods
Focuses heavily on preventive controls and food safety hazards
Emphasizes preventing contamination and foodborne illness
Does not contain the same supplement-specific identity and specification requirements found in Part 111

Many consumers assume supplements are manufactured under the same standards as conventional foods. In reality, dietary supplements have their own dedicated manufacturing regulations under 21 CFR Part 111, which were specifically designed to address the unique quality and identity challenges associated with dietary ingredients. Some facilities may operate under both frameworks depending on the products they produce.

Why DSHEA Matters

Much of today’s dietary supplement framework originates from the Dietary Supplement Health and Education Act (DSHEA) of 1994.

DSHEA established dietary supplements as a distinct regulatory category under U.S. law. It clarified how supplements would be regulated, what claims companies could make, and how FDA oversight would apply.

Whether one agrees with every aspect of DSHEA or not, it remains the foundation of modern supplement regulation in the United States.

What FDA Regulates

One of the biggest misconceptions about dietary supplements is that ingredients can simply be mixed together and sold without oversight.

The reality is more nuanced.

While dietary supplements generally do not undergo the same pre-market approval process as prescription drugs, multiple regulatory pathways exist to help establish ingredient safety before products reach consumers.

Ingredients and Ingredient Safety

Before an ingredient can be used in a dietary supplement, companies must determine that it is lawful for use and meets applicable regulatory requirements.

Depending on the ingredient and its history of use, several pathways may apply:

GRAS (Generally Recognized as Safe)

Some ingredients have a long history of safe use in foods and are considered Generally Recognized as Safe (GRAS).

GRAS status requires qualified experts to conclude that an ingredient is safe under its intended conditions of use based on publicly available scientific evidence.

In the industry we call this Self-GRAS as its not an FDA GRAS status.

FDA GRAS Notification

Companies may voluntarily submit a GRAS notification to FDA for review.

FDA evaluates the submitted safety dossier and may respond that it has no questions regarding the company's GRAS determination.

New Dietary Ingredient (NDI) Notifications

If a dietary ingredient was not marketed in the United States before October 15, 1994, it may qualify as a New Dietary Ingredient (NDI).

For many NDIs, manufacturers are expected to submit evidence demonstrating a reasonable expectation of safety before marketing the ingredient.

These submissions often include:

Toxicology studies
Human clinical data
Historical use information
Exposure assessments
Manufacturing specifications

While the NDI framework continues to evolve, its purpose is straightforward: provide safety evidence before introducing novel ingredients to consumers.

National Advertising Division (NAD)

The National Advertising Division (NAD) is an independent self-regulatory body that reviews advertising claims across many industries, including dietary supplements.

NAD can evaluate scientific substantiation for claims, recommend modifications, and provide an additional layer of accountability outside of government enforcement.

While NAD does not replace FDA or FTC oversight, it represents another mechanism that can help improve advertising quality and consumer trust.

The Layer Many Consumers Never See: Industry Standards

Government oversight is only one part of the quality ecosystem.

Organizations such as USP have spent decades developing standards for ingredient identity, purity, analytical testing, and quality verification. USP standards are developed through expert committees, public comment periods, scientific review, and collaboration with regulatory stakeholders (1).

Additional quality systems often include:

Supplier qualification programs
Certificate of Analysis review
Third-party testing
Ingredient traceability
Finished product testing
Independent certification programs

Consumers rarely see these processes, but they are often where quality is actually built.

Where The System Gets Complicated

One reason supplement regulation can feel confusing is that there is no single global framework.

A product may be classified as:

A dietary supplement in the United States
A natural health product in Canada
A health food in China
A food supplement in Europe
A complementary medicine in Australia

Researchers reviewing international regulations noted significant differences in definitions, market access requirements, labeling requirements, and safety systems across countries (2).

The result is a patchwork of regulations that can create confusion for both consumers and manufacturers.

State Laws: An Often-Overlooked Layer of Regulation

Federal law is only part of the picture.

Supplement companies must also navigate state-specific requirements.

Examples include:

Proposition 65 (California)

Products may require warnings if certain substances exceed established exposure thresholds.

Age Restrictions

Some states have proposed or implemented restrictions on categories such as weight management or muscle-building products sold to minors.

Registration Requirements

Certain states require additional registrations, reporting obligations, or product disclosures.

State Consumer Protection Laws

Marketing claims may face additional scrutiny under state-level regulations beyond federal requirements.

For consumers, these laws create additional protections.

For manufacturers, they create additional compliance challenges that vary by state.

A company may legally sell a product nationally while still needing to meet unique requirements in individual states.

In recent years, several states have proposed legislation restricting the sale of certain sports nutrition, muscle-building, and weight-management products to minors.

While supporters view these measures as consumer protections, critics argue that a patchwork of state-by-state rules can create confusion for consumers and compliance challenges for responsible manufacturers.

Where The System Falls Short

Recognizing regulation exists does not mean pretending the system is perfect.

Researchers continue to identify challenges including:

Adulterated products
Misleading claims
Online marketplace issues
Inconsistent international standards
Consumer confusion
Variable quality among manufacturers

These concerns deserve attention and Ignoring them does more harm than good.

The goal should not be defending bad actors but rather identifying them faster.

What Responsible Companies Can Do Today

Regulations establish minimum requirements, but trust is a higher bar and often built by what companies choose to do beyond those minimum requirements.

Examples include:

Using meaningful ingredient doses supported by evidence
Following cGMP requirements
Performing supplier qualification reviews
Reviewing Certificates of Analysis (COAs)
Conducting finished-product testing
Supporting claims with scientific evidence
Providing transparent labeling
Participating in third-party quality and transparency initiatives
Registering products in transparency programs such as the Supplement OWL Registry

The Supplement OWL Registry

The Supplement OWL (Online Wellness Library) Registry was developed by the Council for Responsible Nutrition (CRN) as a publicly searchable dietary supplement product registry.

The registry helps improve transparency by making label information accessible to retailers, regulators, healthcare professionals, researchers, and consumers.

Participation is voluntary.

While registration is not a substitute for regulatory compliance, it represents an additional step toward marketplace transparency.

What We're Trying to Do at Balterra

At Balterra, we do not believe transparency should be reserved for industry insiders.

Consumers deserve access to the same information and context that formulators, scientists, and regulatory professionals use every day.

Some of the steps we are currently taking include:

Educational Content Without Product Requirements

Many of the articles, videos, podcasts, and educational resources we publish discuss ingredients, regulations, manufacturing, and formulation science that apply to the supplement industry as a whole, not just Balterra products.

We believe informed consumers make better decisions regardless of which brand they ultimately choose.

Supplement OWL Registration

We are currently submitting our product portfolio to CRN's Supplement OWL Registry to provide another layer of transparency and public visibility into our products.

Prop 65 Transparency

Where applicable, we choose to include California Proposition 65 disclosures because we believe consumers should have access to information that helps them make informed decisions.

Evidence-Based Communication

We strive to discuss both the strengths and limitations of ingredients, formulations, and scientific studies.

The goal is not to convince consumers that every supplement works.

The goal is to help consumers better understand which questions should be asked before purchasing any supplement.

We recognize that transparency alone does not guarantee quality. However, we believe transparency is one of the most important foundations for building trust.

A Better Question

The conversation may be more productive if we stop asking:

"Are supplements regulated?"

and start asking:

"How can supplement regulation continue to improve while preserving consumer access to responsible products?"

That question creates room for scientists, regulators, healthcare professionals, manufacturers, retailers, and consumers to work toward the same goal.

Closing

At Balterra, we believe clarity matters more than slogans.

The supplement industry does not need myths defending it.

The supplement industry does not need myths attacking it.

It needs transparency, accountability, and ongoing improvement.

If you could improve one thing about dietary supplement regulation tomorrow, what would it be?

Are Supplements Regulated? Understanding FDA Oversight, DSHEA, and Supplement Safety

The Balterra Promise