It is important that unless you are a doctor, you do not make any medical claims. You can refer people to Google where hundreds of thousands of testimonials can be found.
Big Pharma makes an incredible amount of money treating illness their way. They can’t patent a plant and have no intention of any remedy that is free of charge or not approved by their people to be advertised to people that may use such remedy rather than the FDA one.
Health food stores have had this conundrum for decades. The health food store proprietor may recommend something to try and the person tries it with phenomenal results, but if the FDA catches the person claiming that he/she received a benefit, that person may be fined, jailed, or killed. The Police State that we live in does not play games.
Three CBD companies received letters from the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) warning them against making “unsubstantiated claims” about their products’ medical benefits.
The companies, Advanced Spine and Pain (Relievus) in Jenison, Michigan, Nutra Pure in Vancouver, Washington, and PotNetwork Holdings in Fort Lauderdale, Florida, are accused of promoting these claims on their products, websites, online stores and social media accounts.
In a statement outlining the FDA’s next steps in the process toward regulating CBD, outgoing Commissioner Dr. Scott Gottlieb said the agency will “continue to use our authorities to take action against companies illegally selling these types of products when they are putting consumers at risk.”
The warnings for the four companies related to more than a dozen products and multiple online platforms, on which the FDA said the companies made “unfounded, egregious claims about their products’ ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder and other serious diseases,” without evidence or FDA approval.
Some of the claims the FDA said these companies made were:
“CBD successfully stopped cancer cells in multiple different cervical cancer varieties.”
“CBD also decreased human glioma cell growth and invasion, thus suggesting a possible role of CBD as an antitumor agent.”
“For Alzheimer’s patients, CBD is one treatment option that is slowing the progression of that disease.”
“CBD has demonstrated the ability to block spinal, peripheral and gastrointestinal mechanisms responsible for the pain associated with migraines, fibromyalgia, IBS and other related disorders.”
“CBD reduced the rewarding effects of morphine and reduced drug seeking of heroin.”
The letter to Relievus also warned the company against promoting an “unapproved new animal drug” for its CBD for Dogs product.
This is not the first instance of the FDA sending warnings to companies marketing CBD for animals.
In 2015, two companies – Canna Companion and CannaPet – were warned about their products.
Since 2015, the FDA has sent 47 warning letters to 21 CBD manufacturers for making health claims.
The companies have 15 working days to notify the FDA in writing of the actions taken to correct the violations and to prevent further violations from occurring.
Unheeded letters can result in legal actions, including product seizure.
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Steering clear of legal action
Kalman, who spoke recently on a webinar on labeling claims, has this advice for companies to make sure what they say about their product can withstand legal scrutiny:
Have a scientifically backed study so the results can be translated into structure/function claims, with substantiated evidence.
Not every company can afford to conduct a study, or a finished product to do the study on, so promoting the effects of a particular ingredient using established research might be best option available. Still, Kalman urges companies to work with an attorney and any relevant agency to vet the claims before putting them on labels.
Work with an accounting firm that understands the IRS tax codes that can be utilized by dietary supplement companies, including ingredients. Kalman said there are research and development tax credits available to help with certain expenses, such as salaries or equipment.
When making a structure/function claim, products must have a disclaimer reading: “This statement has (or These statements have) not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
“The disclaimer must appear in bold type on the same display panel as the structure/function claim,” according to the American Herbal Products Association’s guidance.