Diseased Population Study Helps Trigger IND Requirement
Dietary supplement clinical triggers should be thoughtfully considered
A dietary supplement company conducting a clinical study was investigated by FDA’s Bioresearch Monitoring Program and found violations. According to FDA “this program includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected.”
Based on my reading of the letter, it looks like one of the potential issues is the company studying people with insomnia (diseased population) and having disease endpoints.
According to FDA, the company did not submit an Investigational New Drug (IND) application, which is required since the company, according to FDA, was studying the efficacy of their product to mitigate and treat insomnia.”
From FDA: “Whether an investigational article is a drug or a dietary supplement depends on the intent of the investigation. Based on the study design of Protocol ABRI-002, the investigational product, …, as used in the clinical investigation, was a drug as defined in section 201(g)(1) of the FD&C Act, because … was studied for use in the treatment of insomnia.”
The company responded with some interesting retorts.
- “Determining the effect of a dietary supplement on persons with a particular condition does not amount to an intended use of that supplement to treat that condition.”
- “(Company)also stated that because they are in the business of marketing and distributing dietary supplements and not performing clinical studies, there is no risk of future violations because there is no chance of future studies.
If the study had a non-diseased population and endpoints, it probably would have been okay for a “supports normal sleep” statement.
This is a classic chicken-and-egg situation. Because the protocol evaluated the product for the treatment of insomnia (according to FDA), a recognized disease, they viewed the product as an investigational drug and therefore required an IND.
Can supplement clinical trials study diseased populations? In my opinion, it cannot be the sole basis for substantiation, but it can play a role in overall support.
Here are some key takeaways. This is a complex warning letter, and I would love to hear your thoughts.
- Partnering with third parties who understand the legalities and nuances of clinical trials, rather than conducting them yourself, can help eliminate costly regulatory issues.
- Studying a diseased population is not a good standalone substantiation strategy for supplements.
- Possible actions that put this company on the FDA’s radar include alleged issues related to a California Attorney’s General settlement regarding automatic subscription renews, a Truth in Advertising (TINA.org) exposé, and press coverage over their “clinically proven” types of lawsuits.
Read the full warning letter here.
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