shouts Scott Gottlieb FDA Commissioner. He doesn’t like the Farm Bill that designated hemp as an agricultural crop; mainly the legal status of hemp-derived cannabidiol or CBD oil. The “spin” by the FDA claims CBD is a drug ingredient and therefore illegal without approval from his agency. “selling unapproved produces with unsubstantiated therapeutic claims is not only a violation of the law but also put patients at risk, as these products have not been proven to be safe or effective,” Gottlieb barked.
CBD oils have become increasingly popular in lotions, tincture, and foods, but their legal status has been murky, and the Food and Drug Administration has sent warning letters to some companies making health claims for CBD.
As we preached from day one --- Designing an appropriate business model is impossible without a clear legal path. Continuous federal meddling appears designed to cripple free enterprise. Deceptively, the federal government, and especially the FDA wants control over how regulations are interpreted and directly challenges the rule of law and states’ rights. Granted, the Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. However, the Farm Bill designated hemp as an agricultural crop. A "crop" is a plant or animal product that can be grown and harvested extensively for profit or subsistence. ... A crop is usually expanded to include macroscopic fungus (e.g. mushrooms), or alga (algaculture). Crops are harvested as food for humans or fodder for livestock.
We have dedicated resources to develop products that embrace CBD additives only to step back because of interpreations that overrules Congress' intent. Businesses need a level playing field.