In the News

FDA Institutes New Guidance for Supplement Claims

Consumer Groups Blanch As FDA Releases Final Guidelines
for Genetically Engineered Animals

Report: FDA Disregards Researchers' Conflicts of Interest

Sleep Loss Lowers Resistance to Common Cold

FDA Institutes New Guidance for Supplement Claims

The US Food and Drug Administration (FDA) has issued new guidance for dietary supplement manufacturers regarding scientific substantiation for the health claims made on their products. The guidance, published in December 2008, takes the form of recommendations rather than actual policy and refers to all nutritional deficiency, structure/function, or general well-being claims. Open to comment from industry, the recommendations describe the amount, type, and quality of evidence that FDA considers necessary to substantiate claims under section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act.

The new recommendations urge supplement manufacturers to review the support for each label claim and to ensure that the research relates to the specific product and claim, is scientifically sound, and is adequate in the context of the surrounding body of evidence.

The major questions that establish whether supplement information is based on competent and reliable scientific evidence are the following:

• Does each study or piece of evidence relate to the specific claim(s)?
• What are the strengths and weaknesses of each individual study?
• What are the study’s type, design, analysis of results, and peer review input?
• If multiple studies exist, do those with the most reliable methodologies suggest a particular outcome?
• If multiple studies exist, what do the majority suggest or find? Does the totality of the evidence agree with the claim(s)?

FDA’s guidance document offers a discussion of each of these points, together with examples of claims that might be made for dietary supplements. To access the guidance, go to www.cfsan.fda.gov/~dms/dsclmgu2.html.

Consumer Groups Blanch As FDA Releases Final Guidelines
for Genetically Engineered Animals

FDA announced on January 15 the final guidelines that will regulate the production of genetically engineered (GE) animals. The agency emphasized that the GE animals in question are not cloned but instead have new characteristics or traits introduced through their DNA. The new guidelines would require all GE animals to go through rigorous scientific testing before being sold on the market and that food from GE animals will not enter the food supply unless FDA has determined that it is safe. Producers have advanced the development of genetically engineered animals in an effort to produce livestock that are resistant to certain diseases.

In response to the guidelines, scores of organizations and individual citizens posted comments on the FDA website about the possibility of genetically engineered animals entering the public's food system, with many comments objecting to the alteration of animals on ethical grounds. To view the comments, go to www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2008-D-0394.

Consumer organizations oppose the guidelines because they do not include plans to label food from GE animals. Under the current system, unless the physical makeup of the animal is altered, companies and producers will not be required to let consumers know their food products come from a genetically engineered animal.

After FDA's announcement, Consumers Union, the nonprofit publisher of Consumer Reports, issued a statement in which it said that the agency is blatantly ignoring consumers’ right to choose. Armed with a recent Consumers Union poll that found 95% of consumers favor labeling of meat and milk from genetically engineered animals, the organization is actively petitioning the Obama administration for a reversal of the new GE guidelines.

Report: FDA Disregards Researchers' Conflicts of Interest

FDA offers little supervision of potential financial conflicts that doctors involved in clinical trials of drugs and medical devices may have, according to a report released on January 12 by the inspector general of the Department of Health and Human Services (HHS). The investigation fuels an ongoing debate about how money doctors receive for research could distort study results and ultimately harm patients.

In 42% of the clinical trials tracked by HHS, FDA employees failed to procure disclosure forms from physicians. In 31% of the trials in which the agency did receive the required forms, agency reviewers did not document whether they looked at the information. In 20% of the cases in which doctors revealed significant financial conflicts, neither FDA nor the sponsoring companies took any action to mitigate the conflicts. Furthermore, fewer than 1% of the doctors overseeing clinical trials registered with the agency—totaling about 206 of the 29,691 clinical investigators listed. Even those researchers who filed the required disclosures admitted that they had a significant conflict of interest. Because FDA does not maintain a complete list of these physicians, the agency has no way of knowing whether every doctor required to file conflict-of-interest forms actually did so.

The HHS report urged FDA to strengthen oversight by making certain that companies follow the rules regarding financial disclosures, that agency reviewers actually read these disclosures, and that all of these procedures are completed before trials take place so that patients are protected.

Sleep Loss Lowers Resistance to Common Cold

People who get fewer than 7 hours of sleep per night appear about 3 times as likely to develop respiratory illness following exposure to a cold virus than those who sleep 8 hours or more, according to a report in the January 12 issue of Archives of Internal Medicine. Previous studies have demonstrated that sleep deprivation impairs some immune function and that those who sleep approximately 7 to 8 hours per night have the lowest rates of heart disease, illness, and death. Until this study, there has been little direct evidence that poor sleep increases susceptibility to the common cold.

A research team from Carnegie Mellon University, Pittsburgh, studied 153 healthy men and women (average age 37) between 2000 and 2004. Participants were interviewed daily over a 2-week period and reported how many hours they slept per night (sleep duration), what percentage of their time in bed was spent asleep (sleep efficiency), and whether they felt rested from the sleep they received. They were then quarantined and administered nasal drops containing the common cold-causing rhinovirus. For 5 days afterward, the study participants reported any signs and symptoms of illness and had mucus samples collected from their nasal passages for virus cultures; about 28 days later, they submitted blood samples that were tested for antibody responses to the virus.

The less sleep an individual got, the more likely he or she was to develop a cold. Lower sleep efficiency was also associated with developing a cold; participants who spent less than 92% of their time in bed asleep were 5.5 times more likely to become ill than those whose efficiency was 98% or more. Researchers surmised that sleep disturbances influence the regulation of proinflammatory cytokines and histamines that are released in response to infection.