Therefore, based on our review, the use of CBD in animal products does not satisfy the criteria for GRAS status under 21 CFR 570.30. Under section 409, an animal food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. Animal food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Introduction of an adulterated animal food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products.
You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to Shawn Goldman, U.S.
Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835 or by email to [email protected] . Ashley /S/ Director Office of Compliance Center for Drug Evaluation and Research Food and Drug Administration. /S/ Director Office of Compliance Center for Food Safety and Applied Nutrition Food and Drug Administration. Eric Nelson /S/ Director of Compliance Office of Surveillance and Compliance Center for Veterinary Medicine Food and Drug Administration.  CBD is the active ingredient in the approved drug product Epidiolex. Furthermore, the existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain and GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome ). FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under 21 CFR 312.2, unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act. Natural Native has taken the natural benefits of hemp extracts and given them a scientific boost. By embedding the phytocannabinoids within naturally occurring liposomal phospholipids Natural Native’s Hemp Extract Sprays are up to five times (5X) more bioavailable than hemp extracts taken alone. This means that you can get the same effect from a much lower dose. Hemp Extract Sprays are flavored with a light taste of mint or raspberry so it’s a delicious supplement you will enjoy taking daily without any bitter taste. A 2 ounce bottle of Natural Natives CBD Spray comes in 300 mg, 600 mg, 1000 mg, 3000 mg and 6000 mg concentrations of Liposomal Enhanced CBD. A suggested serving is 6 dispensable pumps taken under the tongue twice a day or as directed. Each serving will provide many valuable nutrients including 5 mg of CBD per serving in the 300 mg bottle, 10mg in the 600 mg bottle, 16.7mg in the 1000mg bottle, 50mg in the 3000mg bottle* and 100mg in the 6000mg bottle*. Every cell in your body has what is known as a cell membrane. It is the wall that surrounds the cell and keeps bad things out and good things in. This membrane is made up of two layers of phospholipids, a phospholipid bi-layer. Phospholipids are basically just phosphorus molecules connected to the end of fat molecules. Liposomes are tiny spheres made from cholesterol and naturally-occurring phospholipids. These spheres can surround certain types of compounds and nutrients like Vitamin C, Vitamin E, CoQ10 and CBD and when they enter or come in contact with the cells of the body they are able to feed the cell membranes with the phospholipids and deliver the nutrients contained within them directly to the cells. In the figure above you can the the CBD (represented by the purple ball) encased by the Liposome. INGREDIENTS: NATURAL CBD EXTRACT, FRACTIONATED (MCT) COCONUT OIL, GRAPE SEED OIL, Liposomal Phosphatidylcholine, Phytosolve®, NATURAL FRUIT FLAVORING. *Orders for the 3000 mg and 6000 mg may have additional shipping times as they are produced in small batches as required. states and the District of Columbia have legalized medical marijuana in some form, and more are considering bills to do the same. Yet while many people are using marijuana, the FDA has only approved it for treatment of two rare and severe forms of epilepsy, Dravet syndrome andВ Lennox-Gastaut syndrome.В. Drug Enforcement Administration (DEA) considers marijuana a Schedule I drug, the same as heroin, LSD, and ecstasy, and likely to be abused and lacking in medical value. Because of that, researchers need a special license to study it, says Marcel Bonn-Miller, PhD, a substance abuse specialist at the University of Pennsylvania Perelman School of Medicine.
The DEA considered reclassifying marijuana as a Schedule II drug like Ritalin or oxycodone, but decided ito keep it as a Schedule I drug. The agency did, however, agree to support additional research on marijuana and make the process easier for researchers. "Research is critically needed, because we have to be able to advise patients and doctors on the safe and effective use of cannabis," Bonn-Miller says. He shared some background on medical marijuana's uses and potential side effects. Medical marijuana uses the marijuana plant or chemicals in it to treat diseases or conditions. It's basically the same product as recreational marijuana, but it's taken for medical purposes. The marijuana plant contains more than 100 different chemicals called cannabinoids.
Delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) are the main chemicals used in medicine. THC also produces the "high" people feel when they smoke marijuana or eat foods containing it. Medical marijuana is used to treat a number of different conditions, including: But itвЂ™s not yet proven to help many of these conditions, with a few exceptions, Bonn-Miller says. "The greatest amount of evidence for the therapeutic effects of cannabis relate to its ability to reduce chronic pain, nausea and vomiting due to chemotherapy, and spasticity [tight or stiff muscles] from MS," Bonn-Miller says.