On March 10, 2016, the Philadelphia District Office of the FDA issued a warning letter to online retailer Dr Natural Healing about sales of epinephrine capsules packaged with a dry powder inhaler as a treatment for asthma. The letter gives the company 15 working days to respond.
As of March 31, the website is still offering the “Prime Asthma Relief” products for sale, though a notice toward the bottom of the site says, “Dr Natural Healing inhalers are not intended to be used as rescue inhaler.” A video posted on the site refers to the product as “FDA-registered.”
The FDA letter points out that in addition to the lack of FDA approval for the product, “The OTC bronchodilator final monograph . . . does not include epinephrine for use as an inhaled bronchodilator in a dry powder dosage form and when using a dry powder inhaler” and that the agency is unaware of evidence that the product is safe and effective when used with a DPI. The letter also cites numerous other violations related to labeling and marketing.
In addition, the letter says, “We are very concerned about the safety of (b)(4). Given the available information, it is unclear how much active ingredient would be delivered to a patient when using (b)(4), even if the conditions of use as set forth in the product labeling are strictly followed. Moreover, FDA believes that there is a significant risk that patients will either over- or under-dose themselves when using (b)(4), which could lead to serious and possibly fatal adverse outcomes. Because (b)(4) is intended to be used to relieve acute symptoms of asthma, if the dose of epinephrine delivered via the (b)(4) is not effective, patients may be at risk for serious or potentially fatal asthma exacerbations. At the other extreme, if the dose of epinephrine is too high, patients may be at increased risk for potentially serious adverse reactions. Cardiovascular adverse reactions may be of particular concern given that epinephrine is a non-selective adrenergic agonist.”
According to the website, Dr Natural Healing CEO James Z. Liu “has successfully developed many new products at Abbvie (Abbott Labs), J&J and AstraZeneca” and “personally managed numerous clinical trials from start to completion that contributed FDA 510(k) and NDA approvals on medical devices and drug products.”
Read the FDA warning letter.
Dr Natural Healing Prime Asthma Relief video:
