Is Joy Organics FDA Approved?

02 April, 2025

At Joy Organics, we are committed to crafting premium, effective, and safe CBD products. All our products are produced in FDA-registered facilities—but does that mean they are FDA-approved?

The short answer is no. The FDA does not approve dietary supplements, which means no supplement brand can legally claim FDA approval. Instead, the FDA regulates dietary supplements, like those from Joy Organics, under specific guidelines to ensure product safety and proper labeling.

While supplements don’t undergo the FDA’s premarket approval process, Joy Organics goes above and beyond regulatory requirements—ensuring the highest standards at every stage of production.

Does the FDA Approve Dietary Supplements?

No. The FDA does not approve dietary supplements the same way it approves pharmaceutical drugs.

Prescription and over-the-counter drugs must go through a rigorous premarket approval process to demonstrate safety and effectiveness. This process is governed by the Federal Food, Drug, and Cosmetic Act (FDCA) of 1938.

In contrast, dietary supplements are regulated under the Dietary Supplement Health and Education Act (DSHEA) of 1994, which places responsibility on manufacturers to ensure their products are:

  • Safe for consumption
  • Accurately and truthfully labeled
  • Free from adulteration or misbranding
  • Made with ingredients that are Generally Recognized as Safe (GRAS)

Before supplements reach consumers, manufacturers must comply with these regulations.

What Products Are Eligible for FDA Approval?

The FDA is responsible for protecting public health by ensuring the safety, effectiveness, and quality of certain high-risk products. These include:

  • Prescription & Over-the-Counter Drugs – Must undergo clinical trials and FDA review.
  • Vaccines & Biologics – Includes blood products, gene therapies, and immunizations.
  • Medical Devices (Class II & III) – Such as pacemakers and surgical implants.
  • Food & Color Additives – Must meet FDA safety standards before use.
  • Animal Drugs & Medicated Feeds – Veterinary products require premarket approval.

FDA approval involves multiple phases of research, safety evaluations, and expert reviews. Even after approval, products remain subject to post-market surveillance and facility inspections.

What Is the FDA’s Role in Regulating Dietary Supplements?

The FDA does not approve dietary supplements before they go to market. Instead, the agency enforces regulations and monitors products after they become available.

Once a supplement is on the market, the FDA can:

  • Inspect manufacturing facilities
  • Review product labels
  • Investigate consumer complaints
  • Take action on reports of adverse events

Manufacturers are required to ensure that ingredients are either GRAS or have been reviewed through a New Dietary Ingredient (NDI) notification process. This oversight helps ensure public safety while still allowing innovation in the supplement industry–especially for products like CBD.

What Does "Generally Recognized as Safe (GRAS)" Mean?

GRAS is an FDA designation for substances that are widely accepted as safe based on scientific evidence or long-standing use in food.

Examples of GRAS ingredients include:

  • Certain preservatives
  • Flavor enhancers
  • Vitamins
  • Essential oils and plant extracts

In dietary supplements, GRAS status indicates that an ingredient has been reviewed for safety—though it is not equivalent to FDA approval.

If a dietary ingredient has not been marketed before October 15, 1994, the manufacturer must submit a New Dietary Ingredient (NDI) notification to the FDA, supported by safety data.

FDA Approval vs. FDA Regulation

These terms are often confused, but they mean very different things:

  • FDA Approval means the agency has evaluated a product’s safety and effectiveness before it can be sold. This applies to drugs, certain medical devices, and some food additives.
  • FDA Regulation refers to the rules and standards enforced by the FDA to ensure that products—even those not subject to approval, like dietary supplements and cosmetics—are safe, properly labeled, and manufactured under good practices.

So while dietary supplements are not approved, they are regulated.

How Does a Facility Become FDA-Registered?

The FDA does not “certify” or “approve” manufacturing facilities in the way it does drugs, but it registers and inspects them to ensure compliance with federal law.

Facilities that manufacture dietary supplements, food, or medical devices must register with the FDA. This allows for:

  • Facility inspections
  • Enforcement of Good Manufacturing Practices (GMPs)
  • Oversight of sanitation, quality control, and documentation practices

Registration helps ensure that products are manufactured in clean, well-controlled environments.

Joy Organics Uses FDA-Registered Facilities

At Joy Organics, we don’t just meet industry standards—we exceed them.

All our products are crafted in FDA-registered, GMP-certified facilities. While all dietary supplement manufacturers are required to follow Current Good Manufacturing Practices (cGMPs), we go beyond the minimum standards to ensure exceptional product quality and consistency.

Before partnering with any manufacturing facility, we conduct comprehensive audits to verify compliance with safety, sanitation, and quality protocols.

Many of our facilities hold additional certifications, such as:

  • USDA Organic Certification - With dedicated machine lines to avoid cross-contamination between organic and non-organic products

We also conduct third-party lab testing for every product to ensure they’re free from harmful contaminants and contain accurate levels of cannabinoids.

You can access lab reports for all Joy Organics products, giving you complete transparency and peace of mind.

The Bottom Line

While Joy Organics products are not FDA-approved—because no dietary supplements are—they are made in FDA-registered, GMP-compliant facilities and undergo rigorous third-party testing. We voluntarily hold ourselves to the highest standards of safety, quality, and transparency.

With Joy Organics, you can feel confident choosing safe, premium-quality CBD products–crafted with care and backed by rigorous standards every step of the way.

author
By Todd Smith
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Todd Smith is Joy Organics Chief Operations Officer and Co-founder. Before Joy Organics, he worked in the wellness and nutritional industry for over three decades and helped generate over 1 billion dollars in supplement sales. He has applied that knowledge and experience to empower over 1000 businesses through Joy Organics’ partnership programs. Todd is also the author of a book, podcast, and blog titled Little Things Matter.

dr kimberly
dr kimberly
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Joy Organics CBD contains a variety of phytonutrients and can offer an array of benefits for both mental and physical health. DR. KIMBERLY LANGDON

Dr Langdon is one of the more than 1000 healthcare professionals who use and recommend our products.

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