Risk of Using Mislabeled and Unregulated Cannabidiol Products for Pain Management

By: Zachary Piracha, Pharm.D Candidate 2017

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The following account is a case report I was involved with during my rotation at the FDA. On 06/21/16, the Consumer Complaint Coordinator division of the Food and Drug Administration (FDA) received a report from a consumer that had discovered an online seller of dietary supplements, and purchased the product CannazAll. CannazAll is a hemp cannabidiol (CBD) tincture, 250 mg per bottle, which is used widely for its claims of relieving pain with minimal side effects. The labeling on CannazAll states that it contains negligible levels of THC, the main psychoactive compound found in marijuana. The consumer was taking the tincture daily, and stated that one bottle would last for approximately one month. His dose was 2-3 drops of the liquid orally, 2-3 times a day, and he had been taking the product at this dose for approximately 6 months. The consumer was taking this product because of his chronic back pain, for which he had taken hydrocodone. The opioid medication would blunt his pain, but also give uncomfortable adverse effects such as GI disturbances and day time drowsiness. The consumer claimed the tincture relieved his pain and made him comfortable enough to carry out his activities of daily living. There was no mention whether or not the consumer was taking the tincture concomitantly with the prescription medication.

In April 2016, he had been referred to a back specialist, who prior to treating any patient, required a complete blood and urine panel to check routine lab values, and a drug screen. The consumer submitted to the doctor’s requirements, submitted a blood and urine sample, and disclosed his prescribed opioid pain medications to the doctor.

When he met with the doctor to discuss his analysis, he was shocked to learn that his blood panel showed that he had 83 ng/ml of THC within his blood. According to the complainant, the standard cut off is 50 ng/ml, and as the doctor explained to him, the patient’s level of THC allowed him to meet criteria to be classified as a “drug addict”. This meant that the doctor could not prescribe any medications to him for pain because of the possibility that he would continue his “addict” habits. This was a very troublesome time for the consumer, who had stopped talking the CannazAll and was unable to receive the supplemental pain medication he needed. The doctor had to refer him to a pain management treatment center for drug addicts to receive further treatment.

The consumer stated that he did not smoke or ingest marijuana, nor did he use other hemp product, and he had not been around other people smoking it or using it.  He was very shocked to find out that the CannazAll would contain such high levels of THC, since according to his doctor, his levels showed that he was a very active cannabis user. The patient exclaimed that if he would have gotten into a car accident and was screened for drugs he would have been charged with driving under the influence.

CBD products are not considered dietary supplements as per section 201(ff)(3)(B)(ii) of the FD&C Act, and are not regulated by the FDA.1 Since there is no regulation, it is uncertain what is actually going into the products that are shipped out to consumers. It is not legal to purchase CBD in the  states, and but this does not deter online pharmacies.1 The mislabeling and lack of regulation of this product has uprooted one individual’s life, and has the potential to do the same if there is no action taken to either regulate the product to ensure its removal from the market.

SOURCES:

1. “FDA and Marijuana: Questions and Answers.” FDA and Marijuana: Questions and Answers. N.p., n.d. Web. 11 Oct. 2016.