A Year in Review

If one word could summarize the industry’s hopes and fears over the past 12 months, that word would be safety. A string of food scares in 2007 severely eroded public confidence in FDA. Meanwhile, a wave of negative media articles dented public confidence in dietary supplements and functional foods, two market segments that have been under increasing scrutiny.

Fortunately, the dog days of last year or so may be over. Instead of ending with a whimper, 2006 ended with a bang. In December, Congress passed the Dietary Supplement and Nonprescription Drug Consumer Act, which requires manufacturers of dietary supplements and OTC drugs to notify FDA of all serious adverse events. And this June, FDA finally released its good manufacturing practices (GMPs) for dietary supplements. Both rules should help promote consumer confidence in supplements and will go into effect by the beginning of 2008.

In the media, the industry faced many challenges, as negative stories continued to make headlines. According to the Dietary Supplement Education Alliance (Sarasota, FL), about 30% of the 12,000 stories published between December 2005 and November 2006 were negative, and about 30% focused on safety. That trend appeared to persist in 2007. And on the research front, several positive studies were overshadowed by others with disappointing, mixed, or disputed findings.

Demand for supplements and functional foods remains stable overall, however, despite the adverse publicity. Last July, The Freedonia Group Inc. (Cleveland) predicted that worldwide demand for nutraceutical ingredients will continue to grow by 5.8% per year through 2010. It’s too early to tell what effect the GMPs and FDA’s increased focus on safety will have on the marketplace. However, it’s likely that demand for quality products that are safe and effective-those that the GMPs are designed to produce-will remain strong for the foreseeable future.

What follows is a summary of some of the major events of the past year:

JUNE 2007

June 22, 2007: Proving that good things really do come to those who wait, FDA issues GMPs for dietary supplements-13 years after the passage of DSHEA. Conceding that the GMPs are “better late than never,” Senator Dick Durbin (D–IL) calls for premarket testing. Council for Responsible Nutrition (Washington, DC) CEO Steve Mister calls the rule “a step forward.”

June 5, 2007: A committee of the American Heart Association (AHA; Dallas) recommends that women of childbearing age take a daily multivitamin containing 400 µg of folic acid or a folic acid supplement. AHA notes that folic acid may lower the risk of neural tube defects (NTDs) and some congenital heart problems. However, researchers from Tufts University (Boston) report in the July issue of Cancer Epidemiology Biomarkers & Prevention that there could be a link between the mandatory folic acid supplementation of grains that went into effect in the 1990s and a recent rise in colorectal cancer among adults.

June 1, 2007: FDA advises consumers to avoid toothpaste contaminated with diethylene glycol. The warning is the latest in a series of alerts about products manufactured in China.

MAY 2007

May 29, 2007: FTC fined two companies $172,500 for marketing alleged human growth hormone sprays over the Internet. The products promised consumers could “lose weight while they sleep without diet or exercise” and “erase 10 years in 10 weeks.”

May 14, 2007: The U.S. Supreme Court declined to consider Nutraceutical Corp.’s (Park City, UT) appeal of FDA’s 2004 ban on the weight-loss ingredient ephedra, letting stand a 2006 Circuit Court decision that ruled in favor of FDA.

May 10, 2007: FDA advises consumers to avoid two sexual enhancement supplements after finding that the products contained analogs of sildenafil and vardenafil, the active ingredients in the prescription drugs Viagra and Levitra.

May 1, 2007: FDA commissioner Andrew von Eschenbach, MD, taps David Acheson, MD, director of FDA’s Office of Food Defense, Regulation, and Emergency Response, as his new assistant commissioner for food protection. Despite the heavy publicity surrounding his appointment, Acheson, a rising star in the agency, tells the Washington Post on July 4 that he really dislikes the term “food safety czar.”

APRIL 2007

April 22, 2007: FDA reports that rice protein concentrate imported from China was contaminated with melamine and melamine-related compounds. The protein concentrate ended up in pet food that was later recalled.

April 5, 2007: Harvard School of Public Health (Boston) researchers release the results of a study in the New England Journal of Medicine involving more than 8400 women. The data suggest that giving multivitamin supplements to pregnant women appears to reduce the likelihood that they will give birth to underweight babies.

April 4, 2007: Representative Henry Waxman (D–IL) re­bukes FDA commissioner Andrew von Eschenbach, MD, over the slow pace of an inquiry into allegations that a popular women’s multivitamin contained high amounts of lead. In a letter, Waxman writes that he is “disturbed” by the probe’s lack of momentum.

MARCH 2007

March 21, 2007: French researchers report finding what appears to be an inverse relationship between dietary lignan intake and the incidence of breast cancer in the Journal of the National Cancer Institute. The study involved more than 58,000 food-frequency questionnaires and an average 7.7 years of follow up.

JANUARY 2007

January 16, 2007: Natural Causes author Dan Hurley writes an article in the New York Times stating that between 1983 and 2005, the American Association of Poison Control Centers (Washington, DC) received 1.6 million reports of adverse reactions to dietary supplements. But in a February 6 correction, the Times clarifies that the article should have said 1.6 million exposures, rather than adverse reactions.

January 4, 2007: FTC settles charges against four companies that marketed weight-loss supplements, netting $25 million in penalties. The companies, which sold Xenadrine EFX, CortiSlim, TrimSpa, and One-a-Day Weight Smart, among other products, agreed to limit future advertising claims.

DECEMBER 2006

December 19, 2006: A National Center for Complementary and Alternative Medicine (Bethesda, MD) study published in the Annals of Internal Medicine asserts that black cohosh (Cimicifuga racemosa) has no effect on menopausal symptoms. Trade associations, including the American Botanical Council (Austin, TX) and the Natural Products Association (Washington, DC), dispute the findings.

December 13, 2006: Acting FDA commissioner Andrew von Eschenbach, MD, is sworn in as the nation’s 20th FDA commissioner, ending a nearly 2.5-year vacancy. Von Eschenbach originally pledges to serve as commissioner while moonlighting as head of the National Cancer Institute (NCI; Bethesda, MD) but later leaves NCI to focus on FDA.

NOVEMBER 2006

November 28, 2006: FTC orders a Florida business owner to pay $375,000 to settle charges that ads for HeightMax, a supplement that allegedly makes people grow taller, contained unsubstantiated claims.

OCTOBER 2006

October 19, 2006: In conjunction with FDA and government agencies in Mexico and Canada, FTC sends 112 warning letters to companies marketing unapproved cures or treatments for diabetes over the Internet. As part of the sweep, FDA also sends warning letters to 24 firms.

October 6, 2006: The Global Organization for EPA and DHA Omega-3 (GOED; Salt Lake City) convenes for the first time at Expo East in Baltimore. GOED chairman Robert Orr says the group, which plans to develop omega-3 quality standards, provides companies with an opportunity to become “architects of a new, positive self-regulatory industry framework.”

SEPTEMBER 2006

September 25, 2006: The Coalition for a Stronger FDA (Washington, DC) announces the results of a poll finding that only 30% of consumers say they have “a great deal of confidence” in FDA. The coalition, along with a similar group created in April 2006 called the FDA Alliance (Silver Spring, MD), calls for increased FDA funding. Both groups include former FDA commissioners among its members.

September 21, 2006: A federal grand jury in Cincinnati indicted six individuals associated with Berkeley Premium Nutraceuticals (Cincinnati), the maker of the “Smiling Bob” sexual enhancer Enzyte, with a conspiracy to commit mail, wire, and brank fraud. An IRS special agent in charge of the case said the business practices alleged in the indictment “threaten the very nature of the free enterprise system in the United States.”

September 18, 2006: The Council for Responsible Nutrition (Washington, DC) announces at its annual conference the results of a poll finding that 69% of consumers have confidence in the safety, quality, and effectiveness of dietary supplements. The poll also finds, however, that that number slipped from 78% in 2004 and 71% in 2001.