Is Your Brand Ready for FDA CBD Regulation?

When hemp was legalized with the passing of the Farm Bill in 2018, many were hopeful that FDA regulation of cannabinoid products was just around the corner. However, several years later, no regulatory pathway has been set for our industry as of yet.

Still, we strongly believe that the FDA will at some point step in and classify cannabinoid wellness products as dietary supplements. And in fact, given the current “Wild West” state of our industry, we welcome FDA regulation. Keep reading to learn why we look forward to a regulatory pathway as well as what you can do as a supplement brand to get prepared for this eventuality.

Existing FDA CBD Regulation

What legislation currently exists in the cannabis space? It’s not much, but the FDA has made some efforts.

Signed into law in December of 2018, the Farm Bill allows for the legal cultivation of hemp across the U.S. for the first time, removing it from the federal list of controlled substances. This bill also allows for interstate commerce of hemp and sets out legal distinctions between industrial hemp and marijuana — the difference being industrial hemp contains <0.3% THC by dry weight. Any plant containing more than this amount is classified as marijuana and is therefore illegal.

In addition, the FDA has approved one cannabis-derived drug (Epidiolex) as well as three synthetic cannabis-related drugs (Marinol, Syndros, and Cesamet), which are only available by prescription through a licensed healthcare practitioner. Epidiolex (cannabidiol) is used for the treatment of seizures, and Marinol and Syndros, which contain a synthetic delta-9-tetrahydrocannabinol (THC) are used for the treatment of nausea in chemotherapy patients and anorexia in AIDS patients. Cesamet, which contains the active ingredient nabilone, a synthetic substance with a chemical structure similar to THC, is used for nausea associated with chemotherapy treatment in cancer patients.

Why Regulation Matters

Unfortunately the FDA’s delayed response when it comes to hemp and cannabis has resulted in a market that’s flooded with mislabeled, fraudulent, or even downright unsafe products. 

In 2020 the FDA tested 147 hemp and CBD products. Many products analyzed did not contain the amount of CBD as promised. Of the 102 products that listed a specific amount of CBD on the label, 18 percent contained less than 80 percent of the amount of CBD indicated, 45 percent contained CBD within 20 percent of the amount indicated, and 37 percent contained more than 120 percent of the amount of CBD indicated on the label. Two products that listed CBD as an ingredient on the label were found to have no CBD. One product was even found to contain concentrations of lead which necessitated further testing.  

Most consumers assume that CBD products that have made it onto the shelves of their local grocery store or pharmacy have been tested or vetted in some way. However, this isn’t the case. And since hemp can act as a bioaccumulator — a substance that is very good at absorbing compounds like heavy metals in soil — testing is particularly important in the hemp wellness space.

With the lack of a regulatory agency to protect consumers, it’s currently up to cannabinoid brands to ensure consumer safety by taking matters into their own hands. That means committing themselves to using only the highest quality CBD oil white label or CBD private label products by choosing a manufacturer that conducts itself as if CBD were already classified as a dietary supplement under FDA regulation.

How to Choose a Reputable CBD Oil Contract Manufacturing Partner

If you’re a supplement brand that offers private or white label CBD products, it’s best to do your due diligence now and engage a partnership with a CBD manufacturer that is well prepared for forthcoming FDA compliance. As you conduct your research for CBD contract manufacturing companies, here are a few points to consider.

Third-Party Certifications

A 2019 NSF International survey found that 85% of consumers trust third-party certification organizations to verify product claims. In the absence of government regulation, you can earn the trust of consumers with certifications from the leading independent regulatory entities. When choosing a CBD oil manufacturing company, look for the following CBD certifications:

• cGMP Certification

cGMP, which stands for Current Good Manufacturing Practices, is the main set of regulatory standards created by the FDA that helps ensure products are made reliably with regard to quality and safety.

• Detox Project

The Detox Project through testing procedures gives their stamp of approval to products that are free of glyphosate, the most widely used herbicide in the world.

• ISO Certification

The International Organization for Standardization (ISO) is an independent organization that develops standards to ensure consistency, safety, and sound business practices. Its certificates are issued by external certification bodies rather than by ISO. If a business is ISO-certified, it means that their organization meets certain specified standards related to any of a number of business areas such as manufacturing and safety.

• Certified B Corporation 

Obtaining this designation indicates a company’s commitment to upholding social and environmental standards. To earn this certification, a company must pass a B Lab assessment, which tests five categories: accountability, transparency, performance, availability, and cost.

Certificates of Analyses (COAs)

The most reliable way to know what goes into a cannabis product is to examine its COA, or Certificate of Analysis. This document details lab testing results to confirm the presence of CBD or other cannabinoids as indicated on the product label as well as the absence of unwanted and harmful ingredients such as chemical solvents, heavy metals, mold, and other toxins. As consumers are becoming more educated about CBD products, COAs are increasingly expected by shoppers. The absence of third-party lab testing is a major red flag for wellness brands who are shopping CBD contact manufacturers.

Safe and Eco-Friendly Extraction Methods

Look for manufacturers that source their cannabinoids using pure and eco-friendly extraction methods such as CO2 extraction without the use of harsh chemical solvents. The result is higher purity and potency for a safe, effective blend without the presence of unwanted chemicals.

Number of Years in Business

As the CBD industry is barely a decade old, it’s unlikely you’ll find a manufacturer that’s been in business longer than several years. Still, seek out a partner who has a proven track record of at least three to five years in the industry.

Ensure You’re Ready for FDA CBD Regulation with Natural Supplement Manufacturing

As part of our mission to produce the highest quality, purest cannabinoid products in the world, here at Natural Supplement Manufacturing we’ve always run our business as though we’ve been subject to FDA regulation since day one — back in 2014. 

All of our products are manufactured in our state-of-the-art cGMP and ISO–certified facilities, and every batch of our product line comes with a COA supplied by an independent lab verifying our products contain the optimal amount of cannabinoids and are free of pesticides, herbicides, mold, fungi, heavy metals, and mycotoxins.

While we’re confident that FDA regulation is forthcoming, we’re proud to do our part to protect consumers in the meantime by supplying our CBD contract manufacturing partners with safe, pure, and effective cannabinoid products.

If you’re interested in offering white label, private label, or custom vegan CBD, CBG, CBN, and CBC oil softgels, contact our team today to see how we can best serve you.