The Hidden Truth: Are natural supplements regulated?

November 8, 2025 •

3 min read

Over 50% of U.S. adults take some kind of dietary supplement, yet many are unaware that, unlike drugs, the FDA does not approve them for safety and effectiveness before they are marketed. So, are natural supplements regulated? The answer is more complex than a simple 'yes' or 'no', and it's vital for consumers to understand the nuanced system that governs these products.

Quick Summary

This article explores the regulatory framework governing natural supplements in the U.S., which largely relies on post-market enforcement by the FDA. It details manufacturer responsibilities, the limitations of oversight, and international differences in how supplements are controlled.

Key Points

No Pre-Market FDA Approval: The FDA does not approve dietary supplements for safety or efficacy before they are sold to the public.
Manufacturer Responsibility: The onus is on the manufacturer to ensure their products are safe and properly labeled, including providing evidence for any claims.
Post-Market Enforcement: FDA regulation primarily involves monitoring the marketplace, inspecting facilities, and acting against unsafe or misbranded products after they are on the market.
International Variations: Regulation of supplements differs significantly across countries, with places like Canada and the EU requiring pre-market authorization and approval.
Good Manufacturing Practices (GMPs): FDA requires manufacturers to follow GMPs to ensure product quality, but this does not guarantee a supplement is safe or effective.
Natural Does Not Mean Safe: The term 'natural' on a supplement label offers no assurance of safety, and consumers should be cautious and research products thoroughly.

The U.S. Regulatory Framework: DSHEA and its Implications

The regulation of dietary supplements in the United States is primarily governed by the Dietary Supplement Health and Education Act (DSHEA) of 1994, which amended the Federal Food, Drug, and Cosmetic (FD&C) Act. This law categorizes supplements as foods, not drugs, which significantly impacts how they are regulated and marketed.

FDA's Post-Market Enforcement Role

Under DSHEA, the FDA does not approve dietary supplements before they are sold to the public. Most new supplements can enter the market without prior FDA notification. The FDA's authority is primarily post-market, meaning they regulate products after they are already available.

FDA's post-market activities include inspecting manufacturing facilities to check compliance with manufacturing and labeling rules, monitoring adverse event reports from various sources, reviewing labels and websites for inappropriate claims, and taking action like recalls if products are found to be unsafe, adulterated, or misbranded.

The Critical Role of Manufacturers

Due to limited pre-market regulation, the responsibility for ensuring a supplement's safety and proper labeling falls mainly on the manufacturer and distributor. Companies must evaluate the safety and effectiveness of their products before selling them. Manufacturers are required to follow Good Manufacturing Practices (GMPs), submit a New Dietary Ingredient (NDI) notification with safety information for new ingredients, report serious adverse events to the FDA, and ensure truthful and non-misleading labeling and advertising.

The Importance of Good Manufacturing Practices (GMPs)

GMPs are regulations for manufacturers to ensure products are made to a quality standard, free from contaminants, and accurately labeled. However, the FDA does not approve products, and their resources for testing are limited, focusing mainly on public health issues and specific inspections. Consumers can look for seals from independent third parties that test for quality, but these do not guarantee a product is safe or effective.

A Global Perspective: How Regulation Varies

Regulatory approaches for supplements differ internationally. Unlike the US system's post-market focus, other regions have stricter controls.

Regulation Comparison: US vs. Canada


Feature	United States (FDA)	Canada (Health Canada)
Pre-Market Approval	No; manufacturers must notify FDA for new ingredients.	Yes; all Natural Health Products (NHPs) require a product license.
Product Identification	None	Must display a Natural Product Number (NPN) on the label.
Efficacy Requirements	Manufacturer is responsible for substantiating claims.	Efficacy claims must be supported by valid scientific evidence.
Safety Assessment	Manufacturer is responsible, FDA monitors post-market.	Health Canada assesses safety before approval is granted.

The EU Approach

The European Union regulates food supplements as food products under specific legislation. Manufacturers must comply with EU food laws and typically notify national authorities before marketing a product. Health and nutrition claims need scientific backing and approval from the European Food Safety Authority (EFSA).

Conclusion: Navigating the Market with Caution

In summary, the regulation of natural supplements in the US is primarily a post-market system under DSHEA. This places the onus on manufacturers for product safety and integrity, with the FDA monitoring the market after products are available. The contrast with stricter international systems like those in Canada and the EU highlights the variation in consumer protection. Therefore, consumers must be proactive: researching products, looking for third-party certifications, and consulting healthcare providers before adding supplements to their nutrition diet. The term “natural” does not guarantee safety or effectiveness, making individual vigilance crucial. For additional information, the official FDA website offers resources on dietary supplements.

Frequently Asked Questions

No, the FDA does not approve dietary supplements for safety or effectiveness before they are marketed. The regulation largely happens after the product is already available to consumers.

DSHEA stands for the Dietary Supplement Health and Education Act of 1994. It is the law that defines and regulates dietary supplements, placing them under the food category rather than drugs in the US.

Under US law, the manufacturer and distributor are responsible for ensuring that their products are safe and that any claims made are truthful and not misleading.

Good Manufacturing Practices (GMPs) are a set of requirements established by the FDA for supplement manufacturers. They are intended to ensure product quality, purity, strength, and composition.

Health claims on supplement labels are not evaluated by the FDA before they are marketed. Manufacturers must notify the FDA if they make certain structure-function claims, which must also be accompanied by a disclaimer.

In Canada, natural health products must be approved by Health Canada before they can be legally sold. Approved products are assigned a Natural Product Number (NPN).

Consumers should talk to their healthcare provider before taking any supplement, look for third-party quality testing seals (though these don't guarantee safety or efficacy), and research the manufacturer's reputation.