Though sometimes regarded as a less than exhilarating element in product development, regulations can make or break an ingredient, a product, or even a whole industry. For innovative new ingredients, working within regulatory frameworks can be challenging enough within the U.S. This challenge can grow exponentially when companies operate in multiple countries.
The repercussions of failing to determine if all of a food’s ingredients are in compliance with local regulations can be severe. “The product will be detained at customs and may need to be destroyed,” says Carolyn Fisher, senior scientist with the international regulatory database firm Decernis.
“There is a slow and steady trend toward regional harmonization of regulations such as the EU, South America’s Mercosur, and Belarus, Kazakhstan and Russia forming the Eurasian Economic Union. However, it is time consuming to keep track of what is required”, she adds. Regulations appear in many different formats and languages and can be very difficult to decipher.
Although they are living organisms found naturally in many foods, a probiotic also must be deemed safe before it can be added to a food or drink. The organism’s species and metabolic by-products in a food matrix must be known, says Fisher. Additionally, proof of efficacy is needed if health claims are to be made.
One company making news in recent years with its innovative probiotic has learned to successfully navigate the international regulatory arena. Ganeden Biotech reports its GanedenBC30 has received regulatory approvals in more than 60 countries on six continents with a number of additional countries expected to give a thumbs-up this coming year.
Echoing Fisher’s comments, Mike Bush, senior vice president at Ganeden, notes that each country has its own regulatory guidelines. Obtaining approval for an ingredient requires significant investment, and while some may be obtained in weeks, others require years.
GanedenBC30 has been helped by its attaining a United States Pharmacopeia (USP) monograph, explains Bush. “The general process to obtain approval in another country for the probiotic requires us to first submit safety data and the FDA-no objection letter we received from our self-affirmed GRAS determination.” The USP Monograph is then submitted. “This is usually enough to get us approved,” he adds.
Approvals for health claims have been even more challenging. The European Food Safety Authority (EFSA) has disallowed hundreds of submitted probiotic health claims. Some countries do not even permit the use of the term “probiotic” because it inplies health benefits. EFSA does permit a claim for yoghurt/fermented milk products containing at least “10⁸ CFU per serving of live microorganisms (i.e. Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus)” for individuals with lactose maldigestion. (See http://ow.ly/yyqQ7).
DuPont recently made inroads into the non-EU country of Switzerland as it announced a claim for its Howaru Bifidobacterium lactis HN019. Working in conjunction with a large Swiss grocery chain, the country’s federal Food Safety and Veterinary Office (FSVO) will allow statements on the probiotic’s ability to support digestion by reducing transit times of food through the gut.
Other countries publishing permitted probiotic-associated claims include Canada and Japan. In the latter, claims are product-based and claim-specific under its FOSHU system. The U.S. has not published a list of approved claims.
Much discussion revolves around whether claims can be justified for probiotics in general or whether they are strain-specific. In June, the International Scientific Assn. for Probiotics and Prebiotics published online a consensus statement on the use of the term “probiotic” (document at http://ow.ly/yyp3l) along with comments on regulatory use of that term and opinions on probiotic health claims.
The statement suggests certain health benefits are likely widespread among studied probiotics. Such benefits include “normalization of perturbed microbiota” and production of acid and short chain fatty acids, for example. Other benefits are likely frequently observed among most probiotic strains such as vitamin synthesis and “neutralization of carcinogens.” Last, there might be rarer benefits such as immunological, neurological or endocrinological effects that are strain-specific.
Probiotic organisms will be increasingly important in both healthy lifestyles and for those dealing with illness. Regulating their use and claims will be a matter of fits and starts.