For years, the biggest challenge for CBD brands hasn’t been competition, but uncertainty. The FDA’s recent announcement to create a new regulatory pathway for CBD products finally offers a glimpse of the future, and it looks a lot like the stringent process used for tobacco. This shift will demand rigorous scientific data, strict manufacturing practices, and a significant financial investment. While this may seem daunting, it also creates an opportunity for serious brands to establish legitimacy. We’ll break down what this new framework means and how you can start building a foundation for compliance that will help your business survive and thrive.
Finding a Legal Pathway for CBD Products
On November 25, 2019, the U.S. Food and Drug Administration (FDA) issued 15 warning letters to CBD manufacturers, signaling a shift in its regulatory posture. In the same communication, the agency revealed its intention to develop a formal “pathway” for the sale and marketing of CBD products—a move that could mirror the Premarket Tobacco Product Application (PMTA) process used for vape and tobacco products.
This announcement marks a pivotal moment for the CBD industry, which has operated in a regulatory gray area since the 2018 Farm Bill legalized hemp-derived CBD.
What is CBD?
Before we get into the regulatory details, let’s start with the basics. Understanding what CBD is—and what it isn’t—is the first step for any business in this space. Cannabidiol, or CBD, is one of many compounds found in the cannabis plant. According to the Mayo Clinic, a key distinction is that CBD is not the same as THC (tetrahydrocannabinol), which is the chemical responsible for the “high” associated with marijuana. This difference is fundamental to how CBD is perceived by consumers and regulators alike. Because it’s non-intoxicating, CBD has become a popular ingredient in everything from oils and lotions to beverages and snacks, creating a booming market that has quickly outpaced federal guidelines.
Defining Cannabidiol (CBD)
At its core, cannabidiol (CBD) is a naturally occurring chemical compound derived from the cannabis sativa plant. Unlike its more famous cousin, THC, CBD does not produce psychoactive effects. This single fact is what allowed for the legal separation of hemp (which is low in THC) from marijuana under the 2018 Farm Bill, opening the door for the commercial CBD industry. For businesses, this means your products are built around an ingredient that is federally legal, but its use in consumer goods like food and supplements exists in a complicated regulatory space that the FDA is still working to define. Your responsibility is to source and market this compound correctly.
Types of CBD Extracts
When you’re developing a CBD product, you’re not just using “CBD”—you’re using a specific type of extract, and the one you choose has major implications for your product’s formulation, marketing, and labeling. There are three primary forms of CBD extract, each defined by the cannabinoids and plant compounds it contains. As Healthline explains, these are typically categorized as Full-Spectrum, Broad-Spectrum, and CBD Isolate. Understanding the differences is crucial for meeting consumer expectations and preparing for future labeling requirements that will likely demand this level of transparency. Each type offers a different profile of compounds, which can influence everything from the product’s effect to its legal standing in certain markets.
Full-Spectrum
Full-spectrum CBD is an extract that contains all the compounds naturally found in the hemp plant, including cannabinoids, terpenes, and flavonoids. This also includes a trace amount of THC—less than the federal legal limit of 0.3%. Many consumers and brands prefer full-spectrum products because of a theory known as the “entourage effect,” which suggests that all these compounds work together synergistically to produce a more significant effect than any single compound could on its own. For your business, using a full-spectrum extract means you need to be diligent about third-party lab testing to ensure your THC levels remain compliant.
Broad-Spectrum
Think of broad-spectrum CBD as a middle ground. It contains most of the beneficial compounds from the hemp plant, like other cannabinoids and terpenes, but the THC has been specifically removed. This option is popular among consumers who want to experience the potential benefits of the entourage effect without ingesting any THC. From a product development standpoint, broad-spectrum extracts allow you to market a “THC-Free” product while still offering more than just isolated CBD, which can be a strong selling point for certain demographics concerned about drug testing or THC sensitivity.
CBD Isolate
CBD isolate is the purest form of cannabidiol, containing 99% or more pure CBD. During the extraction process, all other plant compounds—including other cannabinoids, terpenes, and THC—are completely removed. The result is a crystalline powder that is odorless and tasteless, making it incredibly versatile for product formulation, especially in edibles and beverages where flavor is key. For businesses, CBD isolate offers the simplest path to guaranteeing a THC-free product, which can simplify compliance and appeal to consumers who want to avoid THC entirely. It’s a straightforward ingredient, but it lacks the other compounds associated with the entourage effect.
The FDA’s Current Stance on CBD Regulation
The CBD market has grown rapidly, but the rules governing it have not kept pace. For years, the industry has operated in a state of uncertainty. The FDA has made it clear that the existing regulatory frameworks for foods and dietary supplements are not a good fit for CBD. In a significant announcement, the agency stated its intention to work with Congress to create a new, specific regulatory pathway for CBD products. This is a critical development for every business in the space. It signals that while the current situation is untenable, the FDA is not looking to shut down the industry but rather to establish clear, consistent rules that protect consumers and provide predictability for manufacturers.
A New Congressional Pathway
The FDA has officially concluded that it needs a new set of rules to properly oversee CBD products. Instead of trying to force CBD into existing categories like dietary supplements, the agency believes a dedicated regulatory pathway is necessary. This approach would be established through new legislation from Congress, a process the FDA has committed to supporting. For your business, this means that major changes are on the horizon. The goal of this new pathway is to manage the potential risks of CBD while maintaining consumer access. It’s a signal to the industry to prepare for more structured oversight, similar to what exists for other product categories.
Why Existing Frameworks Don’t Fit
You might be wondering why the FDA can’t just regulate CBD as a dietary supplement. The agency has pointed to several key issues that make CBD different. Primarily, there are safety concerns and data gaps related to how CBD affects the body, especially with long-term use. Because CBD is also an active ingredient in an approved prescription drug (Epidiolex), it complicates its status as a supplement. The FDA has determined that these unique characteristics require a tailored approach. Trying to fit CBD into the existing frameworks for food or supplements, the agency argues, would not adequately address these specific safety and labeling challenges.
Key Goals for Future CBD Regulation
As the FDA works with Congress, it has outlined several key objectives for a new regulatory system. These goals give us a clear preview of what future compliance will look like. The focus will be on consumer safety and transparency, including requirements for clear and accurate labels, testing to prevent harmful contaminants, and established limits on CBD content in products. Additionally, the FDA is considering measures like setting a minimum purchase age to protect children. For your business, these goals should serve as a roadmap. Aligning your operations with these principles now—through rigorous testing, transparent labeling, and responsible marketing—will put you in a strong position when new regulations arrive.
Understanding the Risks: Why Regulation is Needed
The push for regulation isn’t just about bureaucratic red tape; it’s rooted in genuine concerns for public health and safety. The FDA’s cautious stance comes from identified risks and a lack of consistent quality across the products currently on the market. For responsible businesses, these risks aren’t just obstacles—they are opportunities to build consumer trust by creating safe, reliable, and transparent products. Understanding the “why” behind the coming regulations helps you anticipate compliance requirements and build a brand that stands for quality. It also highlights the importance of a robust quality management system to ensure your products consistently meet high standards.
Consumer Safety and Potential Side Effects
The FDA has raised specific safety concerns based on scientific data. According to the agency, there is evidence of potential harm to the liver, potential interactions with other medications, and possible harm to the male reproductive system from long-term CBD use. These aren’t just theoretical risks; they are documented concerns that drive the need for oversight. For your business, this means product development and marketing must be handled responsibly. It underscores the importance of not making unsubstantiated health claims and being transparent with consumers about the products you sell. Proper regulation will help ensure that all companies are held to the same safety standards.
The Problem with Product Quality and Purity
One of the biggest problems in the current, largely unregulated market is the inconsistency of the products themselves. Studies have repeatedly shown that many CBD products sold online and in stores are mislabeled. They may contain significantly more or less CBD than the label claims, or they could contain undeclared THC or even harmful contaminants like pesticides and heavy metals. This lack of quality control not only misleads consumers but also poses a direct safety risk. This is why future regulations will almost certainly mandate strict third-party testing and Good Manufacturing Practices (GMPs). Brands that already invest in these quality measures will have a significant advantage.
What Is the PMTA and How Does It Impact CBD?
The PMTA process, introduced to regulate e-cigarettes and vape products, requires manufacturers to submit extensive scientific data proving that their products are appropriate for public health. The cost? An estimated $1 million per product.
This framework has already reshaped the vape industry, favoring large corporations with the resources to navigate the process. For example:
- Altria, a major tobacco company, successfully cleared its IQOS device through the PMTA in April 2019.
- The same year, Altria invested $13 billion in JUUL, acquiring a 35% stake in the company.
If the FDA applies a similar model to CBD, the implications could be just as dramatic.
Lessons from the Tobacco Industry’s PMTA Process
The tobacco industry’s journey through the PMTA process offers a clear preview of what the CBD industry can likely expect. The central requirement of a PMTA is for manufacturers to provide comprehensive scientific evidence showing their product is “appropriate for the protection of public health.” This isn’t just about proving a product is less harmful than cigarettes; it’s about demonstrating its net benefit to the population as a whole. This high standard forced companies to invest millions into clinical studies, toxicological analyses, and behavioral research. For CBD brands watching from the sidelines, the key takeaway is that preparing for future regulation starts now, and it begins with a solid foundation of scientific data.
The Importance of Rigorous Scientific Data
The FDA has already stated that the existing rules for foods and supplements are not a good fit for cannabidiol, confirming that a new regulatory pathway is needed to balance consumer access with risk management. This future framework will almost certainly be built on a foundation of rigorous scientific data. A significant hurdle for the CBD industry is the current lack of high-quality research on the long-term safety and effectiveness of CBD, a challenge also noted by international bodies like Health Canada. To gain approval, companies will need to produce robust toxicological data, stability studies, and evidence supporting any health claims. Compiling this level of scientific evidence is a complex and resource-intensive process. Firms like ours, J&JCC Group, specialize in helping companies prepare these detailed submissions, ensuring they meet the FDA’s stringent requirements from the start.
How Can Small CBD Brands Survive the PMTA?
In regulated industries, the FDA enforces Current Good Manufacturing Practices (cGMP) under specific codes:
| Industry | cGMP Code |
|---|---|
| Pharmaceuticals | 21 CFR 211 |
| Medical Devices | 21 CFR 820 |
| Dietary Supplements | 21 CFR 111 |
| Cosmetics | 21 CFR 700 |
| Food | 21 CFR 101 |
| Beverages | 21 CFR 165 |
These standards require routine inspections, documentation, and compliance, which can be costly and complex. If CBD is subjected to similar scrutiny, small and underfunded companies may struggle to survive.
Adopting Good Manufacturing Practices (GMP)
So, how can your brand get ahead of the curve? The single most important step is to start implementing Current Good Manufacturing Practices (cGMP) right now. Think of cGMP as the gold standard for production. These are the same quality systems the FDA requires for industries like dietary supplements and cosmetics to ensure products are consistently produced and controlled according to quality standards. Adopting these practices involves creating detailed documentation for your processes, maintaining a clean and controlled facility, and implementing rigorous quality checks from raw material to finished product. While it requires an upfront investment, establishing a cGMP framework now will not only prepare you for future regulations but also build a stronger, more reputable brand that consumers can trust.
The Role of Third-Party Testing and a Certificate of Analysis (CoA)
In an industry where trust is everything, transparency is your greatest asset. The best way to demonstrate your commitment to quality and safety is through independent, third-party lab testing. Every batch of your product should be sent to a credible lab to verify its contents. The lab will provide a Certificate of Analysis (CoA), a document that breaks down exactly what’s in your product. A comprehensive CoA confirms the potency of CBD and other cannabinoids and, just as importantly, screens for harmful contaminants like heavy metals, pesticides, and residual solvents. Making these CoAs easily accessible to your customers—via a QR code on the label or a dedicated page on your website—is a powerful way to prove your product is what you say it is.
Marketing Your Products Ethically and Legally
How you talk about your product is just as important as how you make it. The FDA has been very clear on one thing: you cannot market CBD products with claims that they can treat, cure, or prevent any disease. Making such claims is the fastest way to receive a warning letter and damage your brand’s credibility. Instead of focusing on unproven health benefits, shift your marketing narrative to highlight your strengths in quality and transparency. Talk about your commitment to GMP, your rigorous third-party testing, and the clarity of your CoAs. Tell the story of your high-quality hemp sourcing and your clean manufacturing process. This approach not only keeps you on the right side of the law but also attracts educated consumers who value quality and safety over empty promises.
What’s the Right Pathway for Your CBD Product?
The looming regulatory shift forces CBD companies to make a critical choice:
- Stay in the unregulated market, risking future enforcement and limited scalability
- Invest in compliance and infrastructure, preparing for a regulated future dominated by well-funded players
Either path carries risk—but only those who adapt early will be positioned to compete, especially as pharmaceutical giants eye the CBD space.
The Only FDA-Approved CBD Product: Epidiolex
Currently, there is only one CBD product that has received the FDA’s official green light: a prescription drug called Epidiolex. This medication is specifically approved to treat seizures associated with two rare and severe forms of epilepsy. The fact that the FDA has approved CBD as a drug ingredient is a major reason for its cautious stance on consumer products. Under the Federal Food, Drug, and Cosmetic Act, it’s illegal to introduce a substance into the food supply or market it as a dietary supplement if it has already been approved as a drug. This legal precedent, established by Epidiolex’s approval, is the primary regulatory hurdle that any new framework must clear before CBD can be legally sold in other forms.
A Look at International Approaches: Canada’s Model
While the U.S. works to define its regulatory path, other countries offer a glimpse into potential alternatives. In Canada, regulators are exploring a different route entirely. Health Canada is considering a framework that would allow certain CBD health products to be sold over-the-counter without a prescription. The goal is to create a regulated market where consumers can access safe, high-quality CBD products for minor health ailments. This approach would treat CBD much like other non-prescription health products, focusing on consumer safety and product efficacy. This Canadian model represents a potential middle ground—one that ensures oversight without restricting access as much as a prescription-only drug or a costly PMTA-like process would.
Preparing for a New Era in CBD
The FDA’s intention to create a PMTA-style pathway for CBD products could reshape the competitive landscape. While it may raise the barrier to entry, it also offers a path toward legitimacy, safety, and consumer trust.
For CBD brands, the time to act is now. Whether that means scaling up, seeking partnerships, or exiting the market, the decisions made today will define who leads the CBD industry tomorrow.
Frequently Asked Questions
Why can’t the FDA just regulate CBD like a dietary supplement? That’s a great question, and it gets to the heart of the issue. The main reason is that the FDA has already approved a highly purified form of CBD as a prescription drug, Epidiolex. According to federal law, once a substance is approved as a drug, it can’t be legally included in food or marketed as a dietary supplement. Beyond that legal technicality, the agency has also pointed to a lack of comprehensive safety data, especially concerning long-term use and its effects on the liver. These unique circumstances mean the existing rules for supplements just don’t fit, prompting the need for a completely new regulatory approach.
What does a ‘PMTA-style’ process actually mean for a CBD brand? Think of it as a comprehensive scientific review. The Premarket Tobacco Product Application (PMTA) process used for tobacco and vape products requires companies to prove to the FDA that their product is “appropriate for the protection of public health.” This involves submitting extensive data from clinical studies, toxicological reports, and manufacturing analyses. For a CBD brand, this would mean moving far beyond a simple Certificate of Analysis. You would need to provide a deep, scientific file demonstrating your product’s safety, consistency, and quality control, which is a significant investment in both time and resources.
My business is small. What are the most important things I can do now to prepare for these changes? The best thing you can do is start acting like you’re already regulated. The most impactful step is to begin implementing Good Manufacturing Practices (GMP) in your operations. This creates a foundation of quality and consistency that will be essential for any future framework. Alongside that, continue with rigorous third-party testing for every batch and make those results transparent to your customers. Finally, review all of your marketing materials to ensure you are not making any illegal health claims. Focusing on your commitment to quality and transparency is a powerful and compliant way to build your brand right now.
I already use third-party testing. How does adopting Good Manufacturing Practices (GMP) go beyond that? Third-party testing is an excellent and necessary step, but it’s essentially a snapshot of a single, finished batch. Adopting GMP, on the other hand, is about building a comprehensive quality system for your entire production process. It ensures that every single product you make is consistent and safe, from the moment you receive raw ingredients to the final packaging. GMP involves detailed record-keeping, employee training, facility cleanliness, and equipment verification. It’s the difference between spot-checking for quality and building quality into your process from the ground up.
If I can’t make health claims, how should I market my products? This is where you shift your brand’s story from unproven outcomes to provable quality. Instead of hinting that your product can cure or treat anything, focus your marketing on what makes your brand trustworthy. Talk about your meticulous sourcing of hemp, your commitment to clean manufacturing standards, and your transparent testing protocols. You can educate consumers on the difference between full-spectrum, broad-spectrum, and isolate, helping them make an informed choice. This approach builds credibility with savvy consumers and keeps you on the right side of FDA regulations.
Key Takeaways
- Expect stricter rules modeled after the tobacco industry: The FDA is creating a new regulatory pathway for CBD that will likely demand extensive scientific data to prove product safety, much like the rigorous PMTA process required for tobacco and vape products.
- Build your foundation on quality and transparency now: The best way to prepare is to act like you’re already regulated. Implement Good Manufacturing Practices (cGMP), use third-party labs to provide a Certificate of Analysis (CoA) for every product, and focus your marketing on quality, not unproven health claims.
- The future CBD market will favor serious players: The high cost and complexity of future compliance will likely consolidate the industry. Brands that invest in robust quality systems and scientific data now will be the ones positioned to survive and lead in a more legitimate market.