FDA warns wearable tech firm, Korean drugmaker, and sellers of Kratom-derived compound

The US Food and Drug Administration (FDA) has issued a slew of warning letters to companies for marketing products unapproved or adulterated products, failing to meet current good manufacturing practice (CGMP) requirements, and over clinical trial protocol issues.

On 15 July, FDA published more than a dozen warning letters, including one to the Boston-based wearable health technology company Whoop. The company was cited for marketing its Blood Pressure Insights (BPI) feature on its devices without obtaining approval or clearance from FDA.

Wellness product or medical device?

FDA notes that on its website, Whoop described BPI as providing "daily systolic and diastolic blood pressure estimations, offering members a new way to understand how blood pressure affects their performance and well-being." Furthermore, it says the feature is advertised as "delivering medical-grade health & performance insights."

After FDA issued a Form 483 to Whoop about its unauthorized marketing of the BPI function, the company argued that the feature should not be considered a medical device because it is not intended to diagnose or cure a disease or condition. The company further said that it should be treated as a wellness device because it is only intended to maintain or encourage a healthy lifestyle. FDA, however, disagreed with those arguments.

"Based on FDA's evaluation of BPI's intended use, the product is intended to provide a measurement or estimation of a user's blood pressure, which is inherently associated with the diagnosis of hypo- and hypertension, and is therefore intended for use in the diagnosis of a disease or other condition, or in the cure, mitigation, treatment, or prevention of disease," said FDA. "This conclusion is bolstered by both your firm's statements about BPI (e.g., "Higher blood pressure may be an indicator of poor sleep." [emphasis added]) and BPI's design, which outputs a blood pressure measurement to users and provides the reading on a gauge that uses green, yellow, and orange color-coding to indicate a target blood pressure range.

"Our conclusion is consistent with prior FDA actions, as FDA has reviewed and cleared as a medical device other blood pressure measurement products intended to provide a measurement or estimation of a user's blood pressure without explicit reference to diagnosis of hypo- or hypertension in their labeling or otherwise (e.g., devices authorized within product code DXN), because of the measurement's inherent association with those conditions," the agency added.

Protocol failure

FDA also issued a warning letter to a California-based clinical investigator as part of its Bioresearch Monitoring Program (BIMO) for failing to adhere to clinical trial protocols. Mark Savant, a concierge physician and researcher at the San Francisco Research Institute, was cited for failing to follow an investigational plan. More specifically, the agency said he failed to ensure the investigational drug was administered based on trial participants' body weights and that participants met eligibility requirements before enrolling.

“Specifically, Subject [redacted] body weight was documented as 68.9 kg at study entry,” said FDA. “However, on January 19, 2022, Subject [redacted] received a calculated volume of IP according to a body weight of 152 kg instead of 68.9 kg.

“As a result, the final volume of [redacted] received by Subject [redacted] was more than two times the amount of IP that the subject should have received, according to the protocol,” the agency added.

FDA also cited Savant for failing to obtain "legally effective informed consent" for two trial participants before they were enrolled in the study. Savant said he failed to read the institutional review board (IRB) approval letter in full, which stated the need for an additional “Informed Consent Form Addendum for Study Drugs” and that he had taken corrective and preventive actions (CAPA) to fix the error. FDA, however, said the response was insufficient because it wasn't detailed enough.

"We emphasize that as the clinical investigator, you are responsible for ensuring that legally effective informed consent is obtained from subjects before their enrollment," said the agency. "Your failure to obtain informed consent in accordance with 21 CFR part 50 before involving subjects in research jeopardizes the safety and welfare of subjects by denying them an opportunity to fully assess the risks and benefits of their participation in the clinical investigation."

CGMP violations

South Korean drugmaker Daewoo Pharmaceuticals received a warning letter for violating CGMP requirements. FDA investigators said the manufacturer failed to follow proper procedures to prevent microbiological contamination.

Among other violations, FDA said that it found turbulent airflow in critical areas of the filling line that needed to be unidirectional to ensure the product was made in an aseptic and sterilized environment. It also found that the company's simulated aseptic operations did not meet its actual processes.

"We observed significantly more interventions performed during routine batch manufacturing that were either not simulated or reduced in quantity in media fills, as compared to what was observed during production," said FDA. "Notably, a substantial number of these interventions during routine production were unplanned."

Daewoo was cited for insufficient personnel monitoring, poor practices in the aseptic processing areas, and failing to establish adequate written procedures to ensure CGMP.

"Numerous written procedures were either missing or lacked sufficient detail to ensure consistent repeatability between operators," said FDA. "In addition, written procedures lacked sufficient detail, including those for cleaning of the filling line and cleaning of the filling room."

Not for foods or drugs

FDA published warning letters to seven companies, including Shaman Botanicals, My Smoke Wholesale, Relax Relief Rejuvenate Trading, Thang Botanicals, Royal Diamond Imports, Hydroxie, and 7Tabz Retail, for marketing products with 7-hydroxymitragynine, also known as 7-OH. The agency warned the companies that 7-OH was not a lawful dietary supplement and is not allowed in foods. It also noted that there are no FDA-approved drugs with the substance and warned that consumers may be exposed to a product that hasn't been proven to be safe or effective.

Because some of the products containing 7-OH were sold as food and dietary supplements while others were sold as drugs, the warning letters were issued either by FDA’s Human Foods Program or its drug center.

"This action reflects the agency’s growing concern around novel potent opioid products being marketed to US consumers and sold online and in smoke shops, gas stations, and corner stores," said FDA in a statement. “While 7-OH occurs naturally in trace amounts in kratom, the agency’s letters focus on concentrated 7-OH products such as tablets, gummies, drink mixes, and shots, which may be dangerous.

"Some products are adulterated conventional foods or dietary supplements because 7-OH does not meet the relevant safety standard," the agency added. "Others are unapproved new drugs with unproven claims such as relieving pain and managing anxiety."

Unauthorized eye drops

FDA also issued warning letters to three companies, including EyeTech One, Scope Health, and Revitalize Energy for marketing eye drops and ointments to treat eye dryness without approval or clearance. More specifically, the agency noted that the products are typically marketed as providing relief from burning, irritation, and discomfort due to eye dryness.

FDA said the products are being marketed as either ophthalmic emollients, demulcents, or vasoconstrictors that require regulatory oversight.

All the companies cited in the warning letters were given 15 days to respond to FDA.

Warning letters

FDA warns wearable tech firm, Korean drugmaker, and sellers of Kratom-derived compound

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