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    The wild, wild West of unregulated healthcare products in the U.S.

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    Every week, I seem to discover another new product that promises to cure my woes. A small shop near my home displays a sign saying CBD can treat a wide range of things, from mild pain to PTSD. A store down the block suggests buying kratom for anxious pets. 

    However, none of these remedies are regulated, and the FDA has noticed. In the last few years, they’ve issued plenty of warning letters and made moves to regulate these products.

    So what is this stuff? And what changes can we expect in the next year? I decided to get a pulse on a few product categories in the wild, wild West of unregulated healthcare remedies in the U.S. 

    Homeopathic Products

    What are Homeopathic Products?

    Homeopathic care is based on two beliefs:

    1. Substances that cause a certain symptom in healthy people can cure the same issue in a sick person. For example, onions cause healthy people’s eyes to water; therefore onions should be used to treat the common cold.
    2. The more diluted that substance is, the more effective it is. 

    Researchers have found little to no evidence that homeopathic products work. But that hasn’t stopped the market from growing into an almost $3 billion industry.

    Recent FDA Highlights

    • August 2015: As a result of FTC concerns, the FDA held a public meeting to discuss the FDA’s regulatory framework and the advertising claims made by homeopathic products. 
    • December 2017: The FDA released their first draft containing updated guidance for homeopathic products. The guidance included products that would be targeted first, such as those with reported safety concerns and those targeting the elderly, children, and other vulnerable populations. 
    • May 2018: By the time the comment period closed (and extended), the first draft received over 3,000 comments.

    Recent FDA Warning Letter

    In line with their draft guidance, the FDA issued an 11 March 2019 warning letter to Nutra Pharma Corp. for advertising unapproved new drugs the company claimed could be used to treat conditions like cancer and drug addiction.

    The Latest from the FDA

    The FDA released their latest draft guidance in October 2019. Once again, they’re collecting comments, this time until January 2020.

    In addition, the FDA decided to withdraw their previous guidance, “Conditions Under Which Homeopathic Drugs May be Marketed,” written in 1988. They decided the previous guidance was outdated and did not follow the FDA’s “risk-based enforcement approach.”


    What is CBD?

    Cannabidiol (CBD) is a naturally occurring compound found in cannabis plants. 

    A World Health Organization report found that “CBD exhibits no effects indicative of any abuse or dependence potential” in humans. It has some potential medical benefits: Most strongly, it can treat some childhood epilepsy syndromes, but there’s also research that suggests it could help with anxiety, insomnia, and chronic pain. However, the FDA has emphasized that unapproved CBD products, many claiming to treat these conditions, have not been evaluated by the FDA.

    You may have seen CBD added to tons of products, from dietary supplements to bath bombs to chocolate bars and cocktails. 

    Recent FDA Highlights

    • June 2018: The FDA approved Epidiolex, the first drug to contain CBD. Epidiolex treats seizures associated with two forms of epilepsy.
    • December 2018: Congress passed the Agriculture Improvement Act of 2018. Under this law, hemp (cannabis and cannabis derivatives with low concentrations of THC) is “no longer a controlled substance under federal law.”
    • April 2019: The FDA released a statement explaining their next steps for CBD. Plans included a public hearing, creating an agency to take on a potential path for CBD marketing, and warning letters to companies making unsubstantiated claims about their CBD products.
    • May 2019: The FDA held their public hearing, where representatives from academia, healthcare, and manufacturing spoke. By the time the electronic comment submission period closed two months later, they received over 4,000 comments.

    Recent FDA Warning Letters

    In November 2019, the FDA sent warning letters to 15 companies. Violations include selling dietary supplements with CBD, selling food with CBD, and the usual unapproved new drug violations, with companies claiming CBD can treat arthritis, cancer, and many other conditions.

    The Latest from the FDA

    The FDA revised their consumer update to include more detail about the potential harm CBD can cause. The agency will continue to review comments from the public hearing, monitor the current market, and explore how it might update regulations.


    What is Kratom?

    Kratom is a plant that grows in Thailand, Malaysia, Indonesia, and Papua New Guinea. It’s frequently sold, among other things, as a treatment for opioid withdrawal, even though there are no studies to back up those claims. Based on the FDA’s scientific analysis, the agency predicts that kratom affects people similarly to opioids. 

    Kratom is illegal in a few countries across the globe. It is still legal in the United States, though a few states have banned it.

    Recent FDA & CDC Highlights

    • November 2017: The FDA released a public health advisory about kratom. 
    • April 2018: The FDA issued a mandatory recall for Triangle Pharmanaturals products after several tested positive for salmonella. 
    • April 2019: A CDC report found kratom to be the cause of death for 91 cases between July 2016 and December 2017.
    • April 2019: The FDA released its final set of results after testing 30 kratom products for heavy metals. Scientists found that the products contained significant levels of nickel and lead, enough for a long-term user to potentially develop heavy metal poisoning.

    Recent FDA Warning Letters

    The FDA sent warning letters to Cali Botanicals and KratomNC in June 2019. Both companies were selling unapproved new drugs, with claims that their kratom products could treat opioid withdrawal and addiction, along with other conditions.

    The Latest from the FDA

    Outside of issuing warning letters and studies, the FDA has been fairly quiet. However, the DEA is considering labeling kratom as a Schedule I drug, though that’s been in progress since 2016.

    Looking Ahead

    Until these homeopathic or alternative remedies are able to prove their benefits through the same scientific rigor as other products, it will be interesting to see how the FDA continues to keep up with this ever-evolving industry. Will FDA warning letters discourage the marketing and selling of these types of products? Will people be negatively affected by these products? Only time will tell. 

    Annalise Ludtke

    Senior Manager, Marketing Communications at Vodori

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