A recent Warning Letter for conducting clinical trials with a supplement without FDA approval highlights the fine line that separates trials that need the FDA’s pre-approval to initiate and those that don’t. The FDA inspectors dinged a company in California for conducting multiple clinical trials with their probiotics because of certain endpoints selected for those trials, thereby giving a good lesson in what is allowed and what isn’t.
Clinical trials with dietary supplements generally do not require an Investigational New Drug (IND) application with the FDA (called non-IND studies), provided these trials stay within the realm of general health claims allowed by the FDA for supplements. However, the non-IND route is not available to companies developing therapeutic products, even if their products are similar to what might be considered a supplement and hence exempt from IND regulations. ISOThrive is such a company. The company’s website claims it to be a biotech company developing probiotics for various disease indications. The company’s website includes a pipeline of seven indications pursued by the company. However, it seems that the company has been conducting clinical trials erroneously assuming those to be exempt from IND regulations because their products are probiotics. The Warning Letter emphasizes this error.
IND regulations are burdensome. These regulations intend to de-risk clinical trials with new therapeutics, drugs, or biological products. The regulatory definition of a drug is a material intended to treat, prevent, or manage a disease irrespective of the nature of the product. Hence, a product that otherwise may be a food, supplement, or another seemingly benign material, could be classified as a drug based on the claims being made. ISOThrive assumed that its trials were IND-exempt because their probiotic is a commercially available dietary supplement, and the endpoints of the studies were to evaluate only its safety/tolerability. However, the trials included specific “efficacy” endpoints related to diseases, which renders the probiotic to be a biological product per the above definition, and hence INDs were applicable.
It is an open secret that companies conduct clinical trials with supplements to be able to make claims that fall outside those allowed for supplements. And that’s where they can get in trouble with the FDA. ISOThrive’s case is not unique but it highlights the risk a company takes when pushing the envelope too far.
