At the offices of the FDA and the FTC, a matter of concern is that of fraudulent or deceptive advertising claims concerning the safety and the health benefits of children's dietary supplements and functional food products.
Under the law, "false, misleading, or unsubstantiated claims" are illegal. All claims about either the safety or efficacy of health-related products are required to be substantiated by competent and reliable scientific evidence.
Most of the foods, beverages, and substances that people consume have been proven to be safe through long use and scientific research. The need for vitamins and minerals is well established and they are widely available in whole foods, but the science behind supplements is still in its early stages. Very few supplements products have an appreciable history or have passed the test of science. Thus we don't know the results of consuming doses of nutrients or supplement substances over years.
As regards their effects on children, per se, our knowledge of their safety and efficacy is embryonic, and some experts question whether supplements should ever be given to children without definitive testing or at least until their safety has been proven with adults.
The deliberate development of designer formulations that are marketed upon belief can put children at risk. Children's bodies are at a different stage of biological development than adult's bodies. We can't be sure that supplements work the same way in a child's body. Additionally, many highly engineered formulations contain refined substances or chemicals in a mix that are untested by science and often not reviewed for drug interactions. Such products are potentially dangerous. (This also brings up the question of whether the onus for supplement/drug interactions should fall on makers of supplements or drugs.)
Critics of children's supplements argue that when experts say that children naturally get all the vitamins, minerals, and nutritional elements in consuming a diet in line with the US dietary recommendations, what is there to be gained from childhood supplement consumption? These critics worry that we are experimenting on our children.
Failure to deliver a benefit
Very few supplements products have been proven to deliver any verifiable benefit. Wishful, untested, or overblown claims often mislead consumers and can put children at risk because they fail to receive the treatment they may need in lieu of a supplement, or because the supplement may lack the actual efficacy it claims. Does echinacea bolster the immune system, and does it do it for children and at what dosage? There are no definitive answers.
In lieu of verifiable claims, food marketers often overreach the claims allowable under the law, and leverage the words 'natural' or 'wholesome' to suggest that their products are surely 'good.' The FDA recently yanked the "Smart Choices" label off sugary cereals and high salt content soups because it was deceptive. Similarly, Kellogg's has been cited by watchdogs for suggesting that cookies containing fibre and synthetic vitamins are 'wholesome' when they also contained high amounts of sugar, fat and saturated fat.
Likewise, some supplements marketers suggest that their products are effective as "natural alternatives to" prescription drugs or traditional medicines when no preponderance of scientific evidence supports such a claim. Such products prey on parental concerns with such tactics, and suggest themselves as real alternatives in the absence of significant scientific agreement. Can St. John's wort replace SSRIs? Maybe, possibly, unlikely.
Additionally, some companies misleadingly package their products like pharmaceuticals, suggesting, by look and feel, that they are more efficacious than they are.
Regulatory agencies have found many claims to be unfounded in one or both of these respects. That is not to say that there aren't many dietary-supplements products on the market that are of value to consumers. The point is that society needs industry executives to demonstrate full ethical and legal responsibility in the formulation and marketing of products by not acting carelessly or trading on deception. Kellogg's recently withdrew its antioxidant claims with regard to children's immunity on Rice Krispies and Cocoa Krispies, fearing that its words could be construed as suggesting immunity to swine flu. Such care and restraint in the construction and management of claims is essential to ensure both safety and genuine efficacy for children.
To have substantiated claims, a company must have constructed its claims on the basis of scientific evidence to be within the bounds allowable under the law.
Lindsay Moore, PhD, is CEO of KLM, a management consultation firm in Boulder, Colorado, and co-author of Intellectual Capital in Enterprise Success: Strategy Revisited , published by Wiley. Respond: [email protected]