Acronym of the week would be more accurate, but GDUFA will be used as a word so it might as well be defined as one. With the passage of the Food and Drug Administration Safety and Innovation Act on July 9, 2012, GDUFA (‘Generic Drug User Fee Amendments...
by Dr. Cathy Kapica, Senior Vice President, Director, Global Health and Wellness
Digestive health is a
current hot topic, and it is
expected to remain so for the next few years. The role of gaining or maintaining a healthy intestinal microflora (bacteria) is a key factor for digestive health, not to mention the potential impact it has on our overall health. So, the rise in probiotics, prebiotics and synbiotics is no surprise and – since this is such a hot topic that affects our everyday lives, balance and general feeling of well-being – people have a greater understanding of the presence and meaning of these “biotics” in their diet.
Oh, wait. That would be in a perfect world. The reality is that this new (actually old) entry into our diets is complex. When people assess their dietary habits, they need simple solutions; identifying and isolating beneficial biotics that work sounds more than a little daunting. As communicators, we have the opportunity to make the garden of microflora simple for all consumers. And that starts with an understanding of the basics.
Probiotics are live microorganisms which, when present in adequate amounts, confer a health benefit. It is thought that having adequate amounts of good bacteria in the intestine displaces the bad bacteria which cause disease. Probiotics are consumed as part of fermented foods with added live active cultures, such as in yogurt or kefir, or as dietary supplements.
There are numerous products on the market. Yakult, which is now global, originated in Japan in 1935. Danone introduced Actimel into Europe in 1994, and it is now the market leader there. It is called DanActive in North America. Culturelle and Align are two of the most recognized US brands for supplements. However, there are numerous other brands now vying to get their share of this growing market.
Lactobacillus acidophilus and Bifidobacteria are the most common types of bacteria used as probiotics (check out the ingredient list next time you eat yogurt). Bifidobacteria, for example, is the dominant intestinal bacteria of breast-fed babies. To insure safety and efficacy, every bacterial strain and combination of bacterial strains needs to be tested. Many of these strains are considered proprietary. I have been to the Danone ‘probiotic vault’ in their headquarters near Paris. It consists of rooms of freezers—under tight security and climate controls. The role of probiotics in health is being actively investigated for a variety of ailments including diarrhea, chronic intestinal inflammatory diseases, urogenital infections, immune function, constipation/regularity and allergy.
Probiotics are in a strange regulatory space—is it a food, drug, supplement or something else? There is no approved health claim for probiotics in the US, and the European Food Safety Authority has rejected most claims that are made about probiotic products, saying they are unproven.
Prebiotics are the fuel which supports the growth of probiotics. Most prebiotics are fiber, but not all fiber functions as a prebiotic. Synbiotics combine probiotics with their prebiotics.
Bacteria are very sensitive to environmental conditions, such as temperature and pH. So, to be sure an adequate amount of bacteria actually makes it to the lower intestine, millions of bacteria are added with the hope that enough survive to make a home.
So what does this all mean for communicators? Clear, simple and validated messages are paramount when it comes to communicating microflora benefits to consumers. This rule actually applies to all communications, but it is especially important when we are working in an environment that is loaded with confusion and, sometimes, miscommunication. The good news is, consumers are looking to this space to help promote their individual health and well-being, so the brands that deliver factual and credible information have the opportunity to be seen as true dietary partners. Helping people personalize their digestive dietary plans will lead to loyal and committed brand enthusiasts.
Personally, Greek yogurt is one of my dietary staples, not only for the probiotics but the protein and calcium. I also take Culturelle daily because I have found that travel can wreak havoc with good dietary habits, and any help I can get to maintain balance is appreciated.
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