Ray Matulka, PhD, director of toxicology for the Burdock Group, will discuss the regulatory boundaries for probiotics as supplements and foods in the United States.
Global demand for probiotic products may be there, but so are the regulatory obstacles these products continue to face. Nutritional Outlook checked in with Ray Matulka, PhD, director of toxicology for the Burdock Group (Orlando), one of the speakers at the upcoming October 9thProbiotics Workshop at SupplySide West.
His session, “Defining Probiotics: The Growing Market for Probiotics and the Regulatory Challenges of Classification,” will discuss the regulatory boundaries for probiotics as supplements and foods in the United States. Together with co-presenter Ewa Hudson from Euromonitor, Matulka will highlight the important fact that often, regulatory restrictions have everything to do with whether a probiotic product is marketed as a supplement, a functional food or beverage, or OTC or drug.
Nutritional Outlook: From a regulatory standpoint, can you compare and contrast what the probiotic category is undergoing in the United States versus in the rest of the world and especially in the EU?
Dr. Matulka: The stance of the EU, by way of the EFSA statements, is that the term probiotic is inherently a health claim, as the definition of probiotics includes the understanding that probiotics benefit the individual.
The United States government has not yet made a formal statement concerning any differentiation of probiotics from any other food ingredient or dietary supplement, but some within industry would like a separate space carved out for probiotics, as the science backing the beneficial effects of probiotics is strengthening.
Can you point to any specific recent challenges probiotics have encountered recently with the FDA and the FTC?
The FDA and FTC have recently implied (through judiciary actions) that claims made for probiotic products used in dietary supplements and foods need to be backed by clinical trials conducted specifically with the same genus/species of probiotics as the formulation to be sold, and must be at the same levels and the same mix of probiotics. This is a significant hurdle, as it decreases the use of much of the published literature and increases the alignment with clinical trials conducted for drugs.
How could the type of probiotic delivery system a marketer chooses affect whether FDA/FTC regulators view that product as a supplement or as a drug?
The type of probiotic delivery system does not typically have a great effect on the evaluation of the probiotic, as long as the probiotic is being consumed orally. However, if a specific delivery system is tied to the ability of a probiotic to treat, prevent, or mitigate a disease, both FDA and FTC will more likely take a very close look to see if the probiotic would fall into the drug category.
Can you provide any examples of delivery systems that might be more drug-like versus supplement-like in the eyes of regulators?
Any delivery systems that do not use the oral route of delivery are more likely to be seen as drugs. For example, I’ve recently seen some marketing for probiotics to be applied to the skin, which could be perceived as a drug action, since dietary supplements must be consumed orally, while cosmetics are not meant to affect the structure or function of the body.
What advice can you give companies that want to market a probiotic product that is compliant with regulations?
Prior to stating any beneficial claims for the product, make sure that you have done your due diligence and compiled a document citing the evidence that substantiates the claim. This will help you see any deficiencies in the substantiation so that further documentation can be located, or the claim language can be altered such that the claim will more likely be perceived by FDA and/or FTC to be truthful and not misleading.