LEGAL DISCLAIMER: This product should be used as directed on the label and slowly increase your dose approximately every 3-5 days until your condition improves. Never consume extremely high doses of CBD. The average person starts with 5 to 10 mg per day. Consult your doctor before taking CBD or if you are pregnant or nursing. Must be 18 or over for use and or consumption. These products have not been approved by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” The FDA has reviewed and approved one Cannabinoid-based drug called Epidiolex in July 2018 for the treatment of seizures opening the door to more research and studies. Source your CBD products at only reputable retailers with valid certificates of analysis. Each person’s results will vary based on their body and many other factors including but not limited to stress, hydration, nutrient deficiencies, metabolism, and any prescription medication in the system. Consult your physician before starting on herbal or plant-based supplements. Monitor your results daily and stop taking “any” new supplement “immediately” if your body gives you any unwanted symptoms.
USER TERMS: Hemp derived CBD is a natural phyto-nutrient that influences millions of G protein coupled receptors and nociceptive neurons in all mammals so it is exceedingly rare to cause side effects or harm. We at azWHOLEistic have posted many educational videos on CBD and other Cannabinoids to help people determine if they should supplement with these products. As a in store customer, or user of this website you have been provided with much information to determine if you are comfortable using these products. You are responsible for researching the potential effects of CBD before you purchase or use these products. You are also responsible for consulting with your doctor or PCP prior to using these materials. Our lab partners (product manufacturers) provide us with Certificate of Analysis to show the purity and potency of all our products. You as the client “user” take responsibility to do the research on your own prior to consuming any Cannabinoid products.
Under the FD&C Act, any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy. There is very limited information for other marketed CBD products, which likely differ in composition from the FDA-approved product and have not been evaluated for potential adverse effects on the body.
Today’s actions come as the FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed. This includes ongoing work to obtain and evaluate information to address outstanding questions related to the safety of CBD products, while maintaining the agency’s rigorous public health standards. The FDA plans to provide an update on its progress regarding the agency’s approach to these products in the coming weeks.
Today, the U.S. Food and Drug Administration issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA also published a revised Consumer Update detailing safety concerns about CBD products more broadly. Based on the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating today that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.
Violations include marketing unapproved new human and animal drugs, selling CBD products as dietary supplements, and adding CBD to human, animal foods
“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns. In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety – including reports of products containing contaminants, such as pesticides and heavy metals – and there are real risks that need to be considered. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”
The companies receiving warning letters are:
The FDA has previously sent warning letters to other companies illegally selling CBD products in interstate commerce that claimed to prevent, diagnose, mitigate, treat or cure serious diseases, such as cancer, or otherwise violated the FD&C Act. Some of these products were in further violation because CBD was added to food, and some of the products were also marketed as dietary supplements despite products which contain CBD not meeting the definition of a dietary supplement.
Many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD. The revised Consumer Update outlines specific safety concerns related to CBD products, including potential liver injury, interactions with other drugs, drowsiness, diarrhea, and changes in mood. In addition, studies in animals have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels and impair sexual behavior in males. Questions also remain about cumulative use of CBD and about CBD’s impacts on vulnerable populations such as children and pregnant or breastfeeding women.