Today’s consumers are no longer content to purchase food based only upon traditional factors of taste, aroma and appearance. Equally important to the purchase decision is whether or not the food is perceived as “healthy.” So it is only natural that foods containing live microorganisms thought to have a beneficial effect on the body – otherwise known as “probiotics” – have become a consumer favorite at home and abroad.
Food manufacturers – especially those with products in the dairy case – have been quick to acknowledge consumer acceptance of the long-standing association of probiotics with health and wellness benefits and have added lactic acid-producing varieties such as Bifidobacteria or Lactobacilli to products as diverse as yogurt, kefir, juices and waters.
However, the popularity of probiotics with the public has meant increasing scrutiny of labeling and advertising claims for these products with government regulators in both the United States and Europe. Understanding government policies is essential for any company participating in the probiotic marketplace.
How the FDA regulates
The Food and Drug Administration regulates what manufacturers can say on food product labels, including those foods that contain probiotics. Furthermore, the claims made also relate to how the product will be regulated.
While probiotics fall into virtually every product category regulated by the FDA, the agency does not have a single regulatory scheme for probiotics. Categorization as a food, dietary supplement, cosmetic or drug is determined on a case-by-case basis.
The distinction between foods, on the one hand, and drugs on the other, has important implications for FDA regulation of probiotic labeling claims, including any text or graphics on websites where these products are sold.
The current regulatory framework does not address the role of foods in treating, mitigating or curing disease. Probiotic foods that attempt to do so are automatically placed in the drug category and required to go through the drug approval process.
Accordingly, the most frequent food claims permitted by the FDA are structure/function claims with benefits relating to improving digestion and supporting the immune system. Structure/function claims are not required to be reviewed by the FDA prior to marketing and have no restrictions upon them other than that they be truthful and not misleading.
What the FTC regulates
Under a longstanding agreement between the FDA and the Federal Trade Commission, the FTC has primary responsibility for food advertising, including advertising of probiotic foods. The FTC has been particularly active in reviewing probiotic health claims.
The FTC’s key concerns are two-fold: first, any immunity claim that conveys a general or specific health benefit, beyond just marinating one’s immune system, and second, the degree of substantiation necessary to support probiotic health-related claims. The FTC believes such claims must be supported by competent and reliable scientific evidence of a clinically significant enhancement of the claimed health benefit.
Evidence of the FTC’s strong interest in health claims associated with probiotic food products can be found in the settlements in 2010 with The Dannon Co. (Activia yogurt and DanActive dairy drink) and Nestlé Healthcare Nutrition (Boost Kid Essentials).
The FTC alleged that Dannon represented that one serving of its Activia brand yogurt relieved temporary irregularity and helped with slow intestinal “transit time,” and that its DanActive brand drink was clinically proven to help strengthen the immunity necessary to avoid colds or flu.
In addition to paying $21 million in settlement monies, Dannon agreed not to make such claims in the future unless permitted by FDA regulations or unless supported by “at least two adequate and well-controlled human clinical studies . . . conducted by different researchers, independently of each other, that conform to acceptable designs and protocols and whose results, when considered in light of the entire body of relevant and reliable scientific evidence, are sufficient to substantiate that the representation is true.”
Nestlé’s settlement related to claims made about its Boost Kid Essentials beverage, which used an attached straw to deliver probiotics to the drinker. According to the FTC, Nestlé claimed that clinical studies showed that the beverage did a number of things, including strengthened immune systems and reduced the duration of diarrhea. The settlement provides Nestle cannot make such claims unless it too possesses “two adequate and well-controlled human clinical studies” substantiating the claims.
It’s tougher in Europe
Just because a claim passes United States’ regulatory muster does not mean that it is suitable for use in foreign countries. In the European Union, any reference to the term “probiotic” denotes an unauthorized health claim which is prohibited by the European Commission. In 2012 the Commission established a list of permitted health claims, but none of the approximately 260 probiotic claims submitted for inclusion on the list were authorized. Therefore, the use of the health claim “probiotic” is de facto banned in all EU Member States.
Some Member States have also taken their own (interim) initiatives. In May 2013, the Italian Ministry of Health adopted guidelines on probiotics, according to which probiotic microorganisms have traditionally been used in foods and food supplements in Italy for balance of the intestinal flora. Therefore, in Italy, products complying with these guidelines may use the term “probiotic” on the label.
On the other hand, the guidelines also pointed out at significantly different approaches by certain other Member States. For example, Irish authorities have taken a literal view of the EU health claims evaluation and decided that because no probiotic has yet won a health claim under the EU nutrition and health claim regulation, even ingredient descriptions using the term “probiotic” are banned in marketing and promotional materials provided to consumers.
It remains to be seen whether other Member States will follow either the Italian or the Irish example. In any event, it seems that for the time being the approaches of some Member States (i.e. Italy) may be opening a possible legal backdoor for the use of the term “probiotic” in specific Member States as long as no generic descriptors have yet been adopted.
The bottom line: be careful
Consumer interest in healthy foods and probiotics’ long-standing association with health means continuing (if not accelerating) probiotic product offerings in dairy cases at home and abroad. But care must be exercised in marketing probiotic foods because they may become drugs unless their claims are properly described; that is, refrain from referencing a particular disease, treatment or prevention.
And when the decision to make a claim is made, have adequate substantiation for the claim. While the FDA has not established rules regarding what qualifies as adequate support for probiotic-related claims, the FTC is particularly concerned that claims be supported by competent and reliable scientific evidence. Unless adequate evidence exists to support product claims, the product may face regulatory challenges.