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How are Hemp Extract Companies Regulated?

Written July 22, 2019 by Kat Merryfield

How are Hemp Extract Companies Regulated?

While industrial hemp is federally legal, the industry is not yet regulated. Until recently, the ingredients in hemp extracts were unknown. But, in the last couple of years, more information, education, and testing have shed light on the industry, allowing consumers to research hemp extract products before they purchase one.

However, with a lack of regulation, some companies continue to cut corners with false test results, poor quality control, and zero customer service. The FDA has put some guidelines in place, but unfortunately, it hasn’t stopped most hemp extract companies from putting consumers’ health at risk. 

The lack of regulation does not equal lawlessness 

Despite the lack of regulation, there are still guidelines that hemp extract companies have to follow. According to the FDA, for example, hemp extract companies cannot place supplement, nutrition, and dietary facts on their packaging.

In fact, hemp extract companies that make questionable medical claims such as “a cure for cancer,” “treats Alzheimer’s disease,” or “an alternative treatment to diabetes,” suggests to consumers that their brands are FDA regulated even when they are not. Regardless of the validity of these medical claims, without FDA regulation, these statements are non-compliant.

Making unsubstantiated claims only raises a red flag and gives the FDA an opportunity to shut down hemp extract companies that don’t comply with their guidelines.

The strategies hemp extract companies can use to regulate

At Kat’s Naturals, we strive to produce top of the line, safe, and consistent, high-quality hemp extract products. Throughout our four-year production journey, we’ve maintained our commitment to quality even when we started in a small building with zero capital. 

In the beginning, we had our products imported from the EU. It was the only place that regulated how companies harvested and developed quality products. However, in 2016, Colorado began regulating how their crops were harvested and produced, so we made the switch to Colorado growers. 

We then moved our production to a well inspected commercial food kitchen, where we took extreme sanitary measures by handling our products with gloves and bottling our products in a clean environment. 

With our profits, we built what the FDA calls an “inspect-able space.” However, it wasn’t long before our company outgrew the facility, forcing us to expand and add more people to our production team. During this phase, we made cleanliness a number one priority in our facility, and we implemented our own sanitary measures by requiring all employees to wear covers for their clothing, started keeping detailed records and created systems in line with GMP rules for other industries.

Today, we’re in a 9,000 square foot facility and are using the Good Manufacturing Practice (GMP) compliance standards to make sure our machinery is compliant and meets quality standards. In addition, we’re working on our Current Good Manufacturing Practice (CGMP) certification, The US Hemp Authority offers the program, to ensure hemp farmers and producers are prioritizing consistent quality and not avoiding violations.    

These certifications are a long, expensive process, but they set us apart from hemp extract companies that produce knock-off products. The more regulated a company can be, the better their remedies will be for consumers. This fact means our products naturally carry a higher price tag, but our commitment to quality and consumer safety is at the forefront. 

However, we don’t just focus on getting the best certificates possible. We also make sure we have all our batches, ingredients, and data sheets logged to support the findings on our test results. All of our Certificates of Analysis (COAs) are filed, allowing us to update the batch numbers on a consistent basis. 

The regulation work-around for hemp extract companies

Producing a safe and quality product for consumers is our number one priority. With that said, we are taking further steps to self regulate to increase our credibility and prepare for when the FDA starts to regulate the industry. For example, our team at Kat’s Naturals reached out to the Department of Agriculture to see how they view (and categorize) hemp. 

Unfortunately, The Department of Agriculture is still learning how to classifying hemp. Is it produce, food, or another type of crop? 

However, our team believes the Department of Agriculture could classify hemp as produce. In this case,  every facility that handles hemp would have to become certified as a food manufacturer. We’d also have to become a certified food producer because our hemp would go into our sublinguals and edibles as a certified food ingredient. 

While the classification of hemp is yet to be determined by the FDA, passing hemp as a produce could be a possibility. It’d provide our team and other hemp extract companies with regulations and specific guidelines to follow — and it’d give consumers every reason they need to trust that certain hemp extracts are safe and high-quality products. 

The FDA is cracking down on hemp extract companies that cut corners

Even though our team at Kat’s Naturals is taking steps to self-regulate and build trust with consumers, the FDA will eventually provide regulations for the hemp industry. Our company will be ready for the FDA’s rules because we’re already putting guidelines in place. However, if hemp extract companies aren’t prepared or refuse to follow the FDA’s regulations, it could lead to severe consequences. In fact, the FDA is already penalizing certain companies. 

In April 2019,  the FDA and Federal Trade Commission (FTC) issued letters to three hemp extract businesses. The organizations reached out to Nutra Pure in Vancouver, Washington, PotNetwork Holdings in Fort Lauderdale, Florida, and Advanced Spine and Pain (Relievus) in Jenison, Michigan. The FDA and FTC warned against using unsubstantiated health claims to advertise hemp extract products. 

Some of the medical claims included:

  • “CBD reduced the rewarding effects of morphine and drug seeking of heroin.” 
  • “CBD has demonstrated the ability to block spinal, peripheral and gastrointestinal mechanisms responsible for the pain associated with migraines, fibromyalgia, IBS, and other related disorders.” 
  • “CBD successfully stopped cancer cells in multiple different cervical cancer varieties.”

Thankfully, our team is  doing their due diligence and reaching out to the FDA to see how we need to label and advertise our products. In doing so, we’ve developed a good relationship with the FDA and have learned that their goal isn’t to shut down hemp extract companies. Instead, the organization is looking for compliance, which in turn protects the public. 

Ultimately, we’re taking the necessary steps to be as compliant and self-regulated as possible — and other hemp extract companies should do the same. By putting rules and guidelines in place, our industry can provide customers with reliable, consistent, and high-quality products that are safe for everyone to consume. 

With that said, high quality products are more expensive as lab tests, certifications, and quality assurance are costly. However, we truly believe you get what you pay for, and we want consumers to work with reputable and trustworthy hemp extract companies regardless of the price.

Don’t let a friend or family member purchase from a hemp extract company that’s not credible! Share this article so they learn how brands like ours are self-regulating to create the best remedies possible.