August 2, 2007
We all like to share the good news about our products benefits, but especially in todays regulatory climate, its better to wait until the jury reaches an unimpeachable verdict. Can you imagine having to halt a publicity campaign touting glowing research results for your product?
Such a scenario is unfolding for the dairy industry, where emerging evidence gave credence to a milk your diet, lose weight marketing campaign. However, the FTC, in a May 3, 2007, letter, said the agency met with USDA officials and representatives for the campaign, which led to the decision to stop all advertising and marketing activities involving weight-loss claims until further research provides stronger, more-conclusive evidence.
To food companies hoping to offer good news about their products health benefits, coming up with the words conclusive evidence may seem as difficult as moving a mountain. Even with the plethora of health-research data making its way into the media and industrys hands, when is enough data ever enough?
Whether its crafting accurate health messages about foods for ad campaigns or providing reliable information about dietary supplements on a website, one things for sure. Consumers are getting better at wading through spurious claims on their hunt for solid nutrition benefits in products that will help them live longer, healthier lives. A lack of solid scientific evidence backing the benefits of many dietary supplements has cast a negative spell over the industry, forcing consumers to dig into the science behind the products themselves.
A 2006 Ipsos Public Affairs survey funded by the Council for Responsible Nutrition, Washington, D.C., indicated consumer confidence in dietary supplements is declining; but, at 65% of all adults, the number of Americans taking dietary supplements is still high. Daniel Fabricant, Ph.D., vice president, scientific affairs, the Natural Products Association, Washington, D.C., believes conflicting reports on health benefits of products have forced consumers to look at nutrition research on their own.
Bernadette Marriott, Ph.D., principal associate of nutrition and health research, Abt Associates, Inc., Durham, NC, says consumers are increasingly savvy about research. If we look back 20 years ago, you didnt find research studies at all in the public press, she says. Now, in every USA Today, there is use of research-based figures and tables. There is a broader awareness of the value of data and research and what those numbers can do.
The kiss of science
Finding sufficient scientific evidence to back nutrition benefits of products is all the rage. Just look at the success pomegranate juice and blueberries have enjoyed after studies were released regarding their antioxidant status. What you are seeing is products with science behind them have risen to the top. They have established themselves, says Fabricant.
Not all, but a few companies are doing a good job at developing nutritional ingredients and products with scientific support as to the effectiveness of a particular ingredient and how it is related to health benefits, for example, the use of calcium along with vitamin D for bone health, says Ram Chaudhari, Ph.D., F.A.C.N., C.N.S., senior executive vice president, chief scientific officer and co-founder, Fortitech, Schenectady, NY. Other examples include lutein for eye health, zinc for immune health and phytosterols to lower cholesterol.
However, not everyone is convinced. The government requires a large measure of unequivocal data before granting use of a qualified health claim. FDA has denied a 2005 request for a qualified health claim for lutein esters, lutein, or zeaxanthin and reduced risk of agerelated macular degeneration or cataract formation. But the agency approved a 2004 claim for omega-3 fatty acids and reduced risk of coronary heart disease after a petition by Martek Biosciences Corporation, Columbia, MD, cited 42 publications as evidence to substantiate the claim, and FDA added several more to its considerations.
Keys to a good study
Much attention has been focused on putting too much credence on poorly designed studies. So what sort of research should a company look for? The gold standard is a well-designed, randomized, controlled clinical trial. But we cant ignore the value of other studies, too, says Fabricant, who reports you can get the ball rolling by starting off with a test-tube study, then a few animal studies, followed by a small trial, and then a bigger trial.
A study is really valuable when it is longitudinal, when it follows the same people repeatedly over a number of years, says Marriott. She warns against convenience samples, in which a large number of people studied may be conveniently coming to a location like a grocery store or mall. The tendency is to think that because you have a large number of people, its a good study. But those studies scientifically are not considered valid. They are biased. If the people are not representative of our census data of the American public, often that kind of data is a misrepresentation when it is published.
A great deal of scrutiny has been placed on research, especially in lieu of recent fraud convictions of investigators and even deaths of study volunteers in the case of drug trials. The National Institutes of Health developed a Clinical Research Guide with Good Clinical Practices (www.nhlbi.nih.gov/crg/management_gcp.php) to help guide researchers.
One problem in researching foods and botanicals is they are difficult to study. Unlike drugs, they are not purified, isolated substances. If you look at supplement research, it is at such a neophyte stage. Drugs are synthetic, but we dont even know what active ingredients are in botanicals. They may have effects that are so variable. What time of day were they picked, during what season, how were they stored? People have studied ginger their whole lifetime and have barely picked away at some of its factors, says Marriott.
Other concerns arise on how research data is used. When they get the results, often you will see people take data farther than they should. They need to review the variables, not only from a statistical perspective, but a biological perspective, says Marriott.
Ethics of funding research
How funding may affect research conclusions has become a hot topic. An eye-opening article published in PLOS Medicine in Jan. 2007 explored the relationship between funding source and conclusion among nutrition studies. Based on searches of worldwide literature, three article types about soft drinks, juice and milk published between Jan. 1, 1999, and Dec. 31, 2003, were identified for a total of 206 articles. It was discovered that the funding source was significantly related to study conclusions. For interventional studies, the proportion with unfavorable conclusions was 0% for all industry funding versus 37% for no industry funding. The researchers concluded industry funding of nutrition- related scientific articles may bias conclusions in favor of sponsors products.
In an article published in the same issue, Martijn B. Katan, professor of nutrition, Vrije Universiteit, Amsterdam, the Netherlands, reported, When an industry is the major sponsor of research on its own product, unfavorable effects of that product are less likely to be investigated.
But, according to Marriott: Industry funds wonderful research. It depends on how closely controlled the studies are. Many scientists have industry funding, and the industry has said what does and doesnt get published. But scientists primarily funded by industry need to set up contracts so that no matter what they find, it will be published. Marriott reports that an excellent model for industry research exists outside the United States in which a greater amount of money is invested in research, often not even related to their products.
In addition, many industry sources contend that, because of the cost of conducting valid studies, companies tend to be particular about the research they fund. Its easier to justify spending money on research that looks likely to come to a positive conclusion, such as omega-3s and heart health, vs. betting on a long shot.
Research worthy of FDA
If youre thinking about petitioning FDA for a health claim, brace yourself. The scientific hill to climb is steep. No. 1, you have to understand and look at the law. You have to have a big, strong file before youre going to move forward. But the FDA is much more transparent now about what they consider research to meet a claim, says Fabricant.
A 21-page FDA guidance document entitled, Guidance for Industry Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements, outlines the scientific burden of proof that a company must take to the table to make a new health claim.
According to Chaudhari, important criteria for health claims include characterization of a nutrient, effective dosage of a nutrient, upper-limit safety issues, long-term effects, stability in a specific food application and interactions with other components of a food or beverage.
When it comes to meeting customers expectations for real health benefits in food products, planting both your feet in science seems like the smartest way to take the high road.
Sharon Palmer is a registered dietitian with 16 years of experience in health-care and foodservice management. She writes on food and nutrition for newspapers, magazines, websites and books. Palmer makes her home in Southern California and can be reached at [email protected].
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