We have come to rely on over-the-counter (OTC) medications to help ease our everyday aches and pains. For the most part, we feel safe taking these pain relievers without a doctor’s approval, assuming they have been reviewed by the US Food and Drug Administration (FDA). Unfortunately, you may need to get rid of some unapproved pain relievers for safety reasons. The FDA just issued a new warning on certain products marketed as over-the-counter pain relievers. Read on to find out which medications to throw away and for more warnings. If you take this drug, US officials have a new warning for you.
On March 22, the FDA issued a warning that several over-the-counter products were illegally marketed as pain relievers containing cannabidiol (CBD) as they are not approved by the administration. “The FDA has not approved any OTC drugs containing CBD, and none of these products qualify to be legally marketed without a new approved drug application,” the statement said. “Over-the-counter drugs must be FDA approved or meet marketing requirements without a new drug application approved under federal law, including CBD-containing pharmaceuticals, regardless of whether CBD is represented on the labeling as an active or inactive ingredient “. And for more over-the-counter drug warnings, if you’re taking this over-the-counter drug more than twice a week, see a doctor.
The FDA sent warning letters to two US-based manufacturing companies that it says violated the Federal Food, Drug, and Cosmetic Act by selling over-the-counter pain products containing CBD: Honest Globe and Biolyte. Laboratories. According to letters sent by the FDA, Honest Globe sold several products labeled “Elixicure Pain Relief with CBD” and Biolyte sold products containing CBD labeled “Therapeutic Pain Gel” and “Pain Relief Cream.”
“Currently, an OTC pharmaceutical product containing CBD cannot be legally marketed without a new approved drug application, regardless of whether CBD is represented on the label as an active or inactive ingredient,” states the FDA letter to Honest Globe. The FDA says it has requested “written responses from these companies within 15 business days stating how they will address these violations or providing their reasoning and supporting information as to why they believe these products are not violating the law.” And for the most up-to-date information, subscribe to our daily newsletter.
The FDA says that “since CBD has known pharmacological effects in humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in over-the-counter pharmaceuticals that are not reviewed and approved by the FDA.” And since these products have not been evaluated by the FDA, the administration cannot say whether these products are effective for the uses claimed by the manufacturers. The administration has previously sent warning letters to other companies illegally selling unapproved CBD products, which included claims that CBD could “prevent, diagnose, mitigate, treat or cure various diseases.”
The administration says they cannot determine “what might be an appropriate dosage” for the OTC products sold by Honest Globe and BioLyte Laboratories. They were also unable to determine how these products “might interact with FDA-approved drugs or other products or have dangerous side effects or other safety concerns,” as they have not yet been evaluated. And for more drug risks, if you’re taking Tylenol with this, your liver is in jeopardy, experts say.
FDA Senior Deputy Commissioner Amy abernethy, MD, says that the FDA has only “approved a drug that contains CBD as an ingredient,” which is a prescription drug for the treatment of seizures. Any over-the-counter product that claims to include this ingredient is not approved by the FDA and “may have dangerous health side effects and side effects,” according to the agency.
“We remain focused on exploring potential avenues for CBD products to be legally marketed while educating the public on these outstanding CBD safety issues,” Abernethy said in his statement. “In the meantime, we will continue to monitor and take action, as necessary, against companies that illegally market their products, prioritizing those that pose a risk to public health.” And for more information from this administration, if you have this sauce at home, throw it out now, says the FDA.