The FDA continues to pursue CBD corporations – firebird-cbdoil
We advise many of our customers, and in particular our customers in the areas of CBD and skin care, on how to deal with the complex state and federal regulations that apply to the marketing and labeling of their products. One of the ongoing concerns that we raise from customers in this industry is running a compliant business that doesn't end with an enforcement action by the Food and Drug Administration (FDA). Some related topics we've written about are CBD foods, CBD pet products, CBD in alcohol, and CBD topics.
We also wrote about FDA enforcement measures for CBD companies, including measures for CBD companies that sell current products. On April 23, 2020, the FDA announced its last enforcement round. In this case, letters were sent to CBD companies claiming that their products could treat diseases, including opioid addiction, or act as an alternative to opioids. The fact that these claims don't work should be apparent to everyone in the industry at this point, but unfortunately, companies continue to make tremendous medical claims about their CBD products. This is a great way to get an FDA exam.
According to the FDA press release:
The opioid crisis remains a serious problem in the United States and we will continue to act against companies that are trying to profit from the sale of products with unfounded treatment claims, ”said Amy Abernethy, MD, Ph. D. “CBD has not been shown to treat opioid addiction. Opioid addiction is a real problem in our country, and those who are addicted need to get proper treatment from a healthcare provider. There are many unanswered questions about the science, safety, efficacy and quality of unapproved products containing CBD, and we will continue to work to protect the health and safety of American consumers from products marketed in violation of the law.
This round of warning letters was issued to two companies:
- BIOTA Biosciences, LLC of the State of Washington, which markets and sells injectable CBD products and an injectable curcumin product. The products are marketed for serious diseases and as an alternative to opioids. BIOTA Biosciences markets CBD and CBD wholesale extracts for private label. Their products include beverages, CBD mass extracts and water-soluble CBD, as well as injectable curcumin.
- Homero Corp. DBA Natures New Hampshire's CBD oil distributor that markets and sells CBD products for the treatment of opioid addiction and other serious diseases. The company is a private label dealer for CBD products as well as a retailer for CBD products from Green Roads.
Here are some examples of the types of statements these two companies have brought into the hot water (the types of statements that no CBD company should make on its websites or in its marketing materials):
Combating the opioid epidemic. . . BIOTA Biosciences produces and sells effective natural alternatives without side effects. Join the growing ranks of pain, oncology, psychiatry, and naturopathy professionals using BIOTA Sterile CBD Vials. "
VISION: OPIOID-FREE FUTURE. . . Our goal is to supply the world with pharmaceutical products that contain all natural products that contain cannabidiol and other natural compounds. We firmly believe that pharmaceutical grade hemp oil will dramatically reduce the need for opioid-based pain relief and eliminate the global opioid epidemic by offering a safe and natural alternative. . . Contact us to learn more about how our ongoing research and development to improve the bioavailability of natural products with high therapeutic potential and our private label CBD products can help solve this global problem.
CBD. . . and its ability to suppress pain and support detoxification processes has highlighted it as a promising therapeutic for a variety of diseases such as epilepsy, including many challenging neuropathy conditions. When patients are considering trying a new therapeutic, such as CBD, there are many delivery options that can be more effective for the patient. One delivery option is BIOTA CBD Sterile Vial Therapy.
Natures Pure CBD has managed to relieve severe withdrawal symptoms related to opiate addiction. Natures Pure CBD has also removed the ball and chain around the neck of opiate addicts and completely relieved the addiction by using Natures Pure CBD to restore people's quality of life.
The recovery rate from opiate addiction is low and Natures Pure CBD oil is promising for those who suffer from chronic opiate use.
Natures Pure CBD oil works for these drugs, which all have addictive properties: opium, fentanyl, heroin, hydrocodone, oxycodone, methadone, morphine and hydromorphone. Natures Pure CBD Oil was effective in treating and eliminating opiate use.
The list goes on, and we recommend that any company operating in the hemp CBD field take the time to review the letters addressed to all of these companies to understand the types of statements that are prohibited are. The FDA has repeatedly reaffirmed its position that CBD products cannot be marketed for therapeutic or medical purposes without the FDA's safety and efficacy reviews. This requirement applies to all CBD products, including topical products, cosmetic products and food products.
Claims about your products that you put under the definition of a "drug" are certain to end up in the FDA's crosshairs. A thorough review of packaging, marketing copies, and websites for these types of claims is critical for any company that offers current CBD products for sale. We also recommend speaking to a lawyer who is knowledgeable about this topic if you are unsure of how to market your products.
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