The recent warning letter was issued to Madison, WI-based firm MB Solutions, LLC, manufacturer of a line of CBD products branded as BioSpectrum CBD. The company offers CBD tinctures, gummies and topical products as well as a couple of products aimed at pets.
Safety concern with nasal sprays
But it was the company’s nasal sprays in particular that caught the Agency’s attention. Some other fringe delivery modes are seen in the dietary supplement space, such as transdermal patches or sublingual or buccal delivery mores. These generally do not elicit direct FDA comment, though they are technically non compliant. But a nasal spray is something different.
“These products are especially concerning from a public health perspective because intranasal drug products may be rapidly absorbed through the highly vascularized nasal mucosa directly into systemic blood circulation, where they may exert undesirable systemic effects such as increased heart rate or elevated blood pressure. If toxic substances are introduced directly into the nose, harmful local effects such as bleeding, ulceration, or nasal septal perforation may occur,” the warning letter stated.
Loren Israelsen, president of the United Natural Products Alliance, was on then Sen. Orrin Hatch’s (R-UT) staff when the wording of the Dietary Supplements Health and Education Act (DSHEA) was hashed out prior to its passage in 1994. Israelsen said various delivery modes were discussed when it came to how a dietary supplement should be defined. The present definition, which states a supplement is to be taken by mouth to be absorbed via the GI tract, was settled on for a couple of specific reasons.
“For one, dietary supplements were to be regulated as a subset of foods. How do you consume foods? You eat them, you don’t stuff them up your nose,” he said.
“And, No. 2, some of these other delivery systems such as patches and nasal sprays happened to have been used as drug delivery systems and we didn’t want to go there,” Israelsen added.
Very little wiggle room on delivery modes
Attorney Justin Prochnow of the firm Greenberg Traurig said the wiggle room that applies to some other delivery modes can’t be used for nasal sprays. In the case of sublingual delivery, for example, even though some technically non compliant absorption might occur, it goes down the hatch eventually.
“Sometimes people do a spray for your mouth and it might have instructions to hold it under your tongue for 20 seconds before swallowing. But you do swallow it. There is no chance that a nasal spray is going to be ingested in that way,” Prochnow said.
Prochnow said the only way a nasal spray might be construed to be anything other than a prescription or OTC drug might be in the case of saline solutions or other formulations meant purely for nasal hygiene. He doesn’t think a compliant dietary supplement product will ever be able to be delivered in that way. He said his advice for companies considering these offbeat delivery modes for supplements is simple: don’t.
“I have people ask me about suppositories as supplements and there are companies that try to sell patches as supplements. A patch is actually a medical device,” Prochnow said.
