The Federal Food, Drug and Cosmetic Act (FD&C Act) enables the U.S. Food and Drug Administration to regulate drugs, medical devices, cosmetics, and food. The FD&C Act ensures the safety of these substances for human use and protects the consumer from unlawful products1. Through FDA oversight, healthcare providers and patients can be assured of the safety, efficacy, and quality of these products.
In recent years, cannabis and hemp cannabidiol (CBD) have gained popularity for medicinal use. In medical practice, hemp CBD can provide a safe and natural option to manage certain conditions such as pain, sleep, and stress without the intoxicating effects. The FDA recognizes the therapeutic potential of using cannabis to treat and relieve such conditions. In fact, the FDA has made numerous strides to develop regulations to ensure the quality of marketed CBD products2.
Many companies, however, have unlawfully marketed cannabis and cannabis-derived products. Such products do not comply with the FD&C Act and market false or misleading claims. These products present a major risk to the public. One of the biggest risks surrounding these products involves quality. Many of these companies and facilities that produce CBD products lack adequate quality control processes3.
The FDA has investigated the composition of unregulated products, and many did not contain the CBD levels they claimed. Per a report submitted to Congress on July 8, 2020, the FDA evaluated 147 marketed products. Of this sample, two products claiming to contain CBD contained no detectable amounts of CBD. The FDA concluded that 18 products had less than 80 percent of the labeled CBD amount, while 38 products had more than 120 percent of the labeled CBD amounts. In addition, THC levels were as high as 3.1 mg per serving of product with almost 49 percent of products containing THC4.
Similar studies from the Journal of the American Medical Association, National Institute of Health, and Johns Hopkins indicate similar findings. A federal lawsuit recently examined products marketed as containing “no heavy metals or insecticides”. The investigation found these products failed quality testing for contaminants such as heavy metals, yeast, and mold5. Another marketed product, known as Kore Organic Watermelon CBD Oil, was recalled in July of 2020 due to high lead content6.
Though the benefits of CBD are well-accepted amongst many members of the medical community, providers must ensure their recommendations are safe and effective. Yet, it is difficult to discern high-quality CBD products due to the frequency of labeling discrepancies and contamination. Therefore, when deciding to use CBD, providers must turn to qualified products and refrain from using unknown sources that may have medical and legal implications. It is important to select a product that has substantiated labeling claims and complies with FDA regulations.
MedEcho, CBD Derived for Healthcare has created a quality check program called “Earth-to-Extract” that conducts 5x testing on all products. Not only are the MedEcho products manufactured in the USA but are produced in FDA- and OTC-registered facilities utilizing some of the highest quality hemp plants in the country. Each product contains its own Certificate of Quality Assurance providing doctors and their patients a guarantee of CBD purity and potency and THC level assurance below 0.3%, per federal regulations (2018 Farm Bill). Our Hemp CBD is also organically derived, non-intoxicating, and free of toxins.
Visit www.EarthtoExtract.com to learn more.
1. (2021). How did the Federal Food, Drug, and Cosmetic Act come about? FDA. https://www.fda.gov/about-fda/fda-basics/how-did-federal-food-drug-and-cosmetic-act-come-about
2. (2021). FDA regulation of cannabis and cannabis-derived products, including cannabidiol(CBD). FDA. https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
3. (2021). What you need to know (And what we’re working to find out) about products containing cannabis or cannabis-derived compounds, including CBD. FDA. https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis
4. Hahn, S. (2021). Sampling Study of the Current Cannabidiol Marketplace to Determine the Extent That Products are Mislabeled or Adulterated. FDA. https://www.perkinscoie.com/images/content/2/3/v2/235603/CBD-Marketplace-Sampling-RTC-FY20-Final.pdf
5. Evans, D. G. (2020). Medical fraud, mislabeling, contamination: All common in cbd products. Missouri Medicine, 117(5), 394–399.
6. Research, C. for D. E. and. (2020, July 28). Summitt labs issues voluntary nationwide recall of kore organic watermelon cbd oil due to high lead results. U.S. Food and Drug Administration. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/summitt-labs-issues-voluntary-nationwide-recall-kore-organic-watermelon-cbd-oil-due-high-lead