In the 10 years that Nutritional Outlook has reported news about dietary supplements and functional foods, we've seen some pretty amazing changes. New discoveries about nutrition have saved lives, fortunes have been won and lost, and new manufacturing regulations have made the industry safer than ever. Yet today's natural products executives still face some of the same challenges their forerunners faced a decade ago.
When Nutritional Outlook's publisher and founding editor, James Wagner, wrote his first editorial for the magazine in 1998, he noted that the supplement industry stood at a crossroads between niche market and mainstream acceptance. Ten years later, natural products have moved forward considerably toward the mainstream, but opposition still remains.
Critics still confuse illegal products with legitimate supplements. Researchers still know little about the way nutrients and herbs should be analyzed. Marketers still make exaggerated claims and use substandard products. And FDA (Rockville, MD) still remains unwilling or unable to fully implement DSHEA. But in other ways, the situation is much improved. Mainstream health experts are much more willing to accept and acknowledge the importance of nutrition. In addition, the industry is now actively involved in funding research, educating consumers and legislators, and setting its own agenda. To prepare for our 10th anniversary issue, we scoured our back catalog to identify some of the major developments of the last 10 years. We hope to follow up again in 2018.
January 29, 2008: Experts disagreed on FDA's ability to fulfill its mandate at a congressional hearing. Covington and Burling LLP (Washington, DC) senior counsel Peter Barton Hutt said "the agency is barely hanging on by its fingertips." But FDA commissioner Andrew von Eschenbach, MD, demurred, telling the hearing participants that "it's not that it's bad, it's that it's at a level of excellence that needs to continue to improve and expand."
The More Things Change...10 Years in the Supplement Industry
In 1998, the Clinton impeachment trial dominated the headlines. The most coveted electronic device was the iMac, not the iPhone. Gasoline cost just $1.06 per gallon. In other words, a lot can change in 10 years. Take the dietary supplement industry, for instance. In 1998, herb sales were up 79%. The hottest botanical ingredient was Ginkgo biloba. Perhaps the most significant problem facing the industry was the lack of official good manufacturing practices (GMPs) for dietary supplements.
"Ten years ago, the dietary supplement industry had no framework for consistent quality," says Roma Bergstrom, CEO of Bergstrom Nutrition (Vancouver, WA). "The industry was considered to have no government regulation and no self-regulation."
Bergstrom adds that when the Natural Products Association (Washington, DC; formerly the National Nutritional Foods Association) created its GMP certification program in 1999, the industry took a big step forward.
Now that the GMPs are here, concern has shifted to their implementation, says Season Solorio, director of public relations at the Council for Responsible Nutrition (CRN; Washington, DC). Meanwhile, safety and quality, two issues that already were important back in 1998, are even more crucial today. "The hot issue today is food safety," says Solorio. "All industries, not just the dietary supplement industry, want to be sure that consumers have access to safe, high-quality products in this global economy. As such, the passage of GMPs specific to dietary supplements could not have come at a better time for the industry."
"Quality has become much more of a focus than it was 10 years ago," adds Bergstrom. "There are more companies trying to cash in on the growth of supplements, some of which have delivered more on price than quality. As the industry matures, it's doing a better job of regulating itself and gaining consumer confidence for quality."
November 13, 2007: A poll commissioned by the Council for Responsible Nutrition (CRN; Washington, DC) found that 79% of doctors and 82% of nurses recommend supplements to their patients. Moreover, 72% of doctors and 89% of nurses said they personally use supplements.
November 5, 2007: Metabolife International Inc. (San Diego) founder Michael Ellis pled guilty in federal court to making false statements to FDA. According to the office of the U.S. Attorney for the Southern District of California, Ellis told FDA in 1999 that the company had a "claims-free history" and had "never" received a serious adverse-event report about its products. The company later handed over thousands of documents.
June 25, 2007: Official good manufacturing practices (GMPs) for dietary supplements appeared in the Federal Register, nearly 13 years after the passage of DSHEA. The GMPs finally put to rest claims that there are no laws governing dietary supplement manufacturers. Or did they? Nine months later, a March 12, 2008, San Diego Union-Tribune article described the industry as "largely unregulated."
May 14, 2007: The U.S. Supreme Court denied certiorari in the case of Nutraceutical Corp. v. Von Eschenbach, effectively upholding FDA's 2004 ban on dietary supplements containing ephedrine alkaloids.
December 12, 2006: President George W. Bush signed the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which requires manufacturers of OTC drugs and dietary supplements to report serious adverse events to FDA.
September 14, 2006: The FDA Alliance (Silver Spring, MD) demanded more funding for FDA. Less than two weeks later, another group, the Coalition for a Stronger FDA (Washington, DC), did the same. The pleas fell largely on deaf ears; the White House requested only slight increases in the FDA budgets for 2008 and 2009.
October 22, 2004: With bipartisan and industry support, the Anabolic Steroid Control Act of 2004 became law and classified androstenedione as a controlled substance.
September 22, 2004: The Dietary Supplement Education Alliance presented to Congress the results of a study by the Lewin Group (Falls Church, VA) that found that dietary supplements could save Americans at least $15 billion in healthcare costs. Jeffrey Blumberg, PhD, a professor at Tufts University's (Medford, MA) Friedman School of Nutrition Science and Policy, called the estimate "extraordinarily conservative."
August 2, 2004: Product labels got a bit more crowded when the Food Allergen and Consumer Protection Act of 2004 went into effect, requiring food and supplement manufacturers to list the common names of major food allergens like dairy, wheat, and soy.
April 12, 2004: FDA banned dietary supplements containing ephedrine alkaloids, declaring them to present "an unreasonable risk of illness or injury."
March 11, 2004: FDA declared the steroid precursor androstenedione to be a new dietary ingredient and launched a crackdown on androstenedione products.
December 12, 2003: The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 went into effect.
March 13, 2003: FDA proposed GMPs for dietary supplements in the Federal Register. Publication of the final rule was delayed until June 25, 2007.
February 17, 2003: Baltimore Orioles pitcher Steve Bechler died during practice after reportedly taking an ephedra supplement, prompting greater congressional and media scrutiny of dietary supplements. At a press conference, former Health and Human Services (Washington, DC) secretary Tommy Thompson shared his views of ephedra with reporters: "I wouldn't use it. Would you?"
The Top 25 Supplement Companies in 1998
|Rank||Company||Sales (in $ Millions)|
|16||Nutrition for Life||69.66|
October 21, 2002: USDA's (Washington, DC) National Organics Program went into effect, creating a set of official standards for foods and supplements that contain organic ingredients.
April 10, 2002: A study in JAMA panned St. John's wort (Hypericum perforatum), finding it ineffective for moderate and severe depression and ushering in an era of falling sales for the herb. Herbal supplement experts were quick to point out that St. John's wort generally is not indicated for moderately to severely depressed people.
November 21, 2001: The European Commission (EC) fined eight companies a total of €855.22 million for participating in market-sharing and price-fixing cartels that affected the prices of vitamins A, E, B1, B2, B5, B6, C, and D3, as well as biotin, folic acid, and beta-carotene. EC competition commissioner Mario Monti chastised the companies, calling the cartels "the most damaging the commission has ever investigated due to the sheer range of vitamins covered."
March 23, 1999: The Supplement Facts panel appeared on all dietary supplement labels for the first time, providing consumers with useful information such as the manufacturer's suggested serving size and nutrient Daily Values, as well as more-detailed descriptions of botanical ingredients.
October 21, 1998: President Bill Clinton signed the Omnibus Appropriations Act of 1999, establishing, among other things, the National Center for Complementary and Alternative Medicine (NCCAM; Bethesda, MD). Since 1998, NCCAM has dispensed millions of dollars in funding for natural products and complementary medicine research.
October 16, 1998: The American Botanical Council (Austin, TX) published the first English translation of the Complete German Commission E Monographs–Therapeutic Guide to Medicines. The book's 380 cross-referenced monographs included data such as nomenclature, plant composition, uses and indications, side effects, and potential interactions with medication.
September 8, 1998: St. Louis Cardinal Mark McGwire broke the single-season home-run record set by Roger Maris in 1961. Consumer interest in steroid precursors rose after the media reported that McGwire had used androstenedione.
10 Years of Change: A Trade Association's Perspective
By the Council for Responsible Nutrition
With the passage of DSHEA, many new products entered the marketplace and consumers were eager to try them. The 1990s was a booming time for the supplement industry, with the highest percentage growth in sales and a large body of epidemiological research in favor of vitamin and mineral supplements.
But by the turn of the millennium, the dietary supplement industry had entered a new era, with the medical research community insisting on randomized clinical controlled trials to test the scientific theories hinted at by observational studies-with those results often not supporting the glory days of epidemiology. Regardless of the fact that many of the trials conducted were either an inappropriate model for studying the effects of nutrients, flawed in design, or simply an over interpretation or misinterpretation of the results, negative publicity resulted.
In addition, as FDA, likely disgruntled at the passage of DSHEA over its objection, chose not to enforce the law, the media began questioning both the science and regulation behind the supplement industry.
Then came concerns about ephedra and the alleged association between the supplement and the death of baseball player, Steve Bechler. The industry found itself under siege.
But the industry fought back-declaring there was a responsible part of the industry that followed regulations, wanted stronger enforcement of the law, despised outrageous advertising claims-in short, wanted the industry to be known by its responsible companies, rather than by the small percentage of outliers. In the last four or five years, there's been slow, but steady, shift back towards the positive side of supplements, thanks to many of the efforts put forth by CRN (and others).
Although CRN did not agree with FDA's rationale for removing ephedra from the marketplace, the association supported FDA's decision, given consumer's seeming inability to follow label directions for this product. In addition, the trade association lobbied hard to remove anabolic steroid precursors, like androstendione, from the supplement marketplace and to pass a bill mandating reporting of serious adverse events to FDA.
Further, in response to criticism for the outrageous advertising claims of some supplement companies, CRN began to encourage self-regulation in the industry through a partnership with the National Advertising Division of the Council of Better Business Bureaus (Arlington, VA). With food safety becoming more of a concern amongst consumers, the long-awaited good manufacturing practices (GMPs) specific to dietary supplements could not have come at a better time, being passed in 2007 and giving consumers further peace of mind that supplements were safe and manufactured to high-quality standards. Once again, it was regulation that the industry fought hard to get.
Along with industry changes came changes in consumer wants and needs, as Americans started to take charge of their own health and actively look for ways to increase their overall wellness.
While CRN has continued to stay true to the science behind supplements, it has also become much more active on Capitol Hill, becoming a highly respected source for information for members of Congress and their staff. The association's consumer outreach has also grown, particularly with CRN's aggressive posture on responding to the study "du jour" and the launch of the "Life…supplemented" consumer wellness campaign.
When Steve Mister, CRN's president and CEO, started his tenure at the association, he reminded the association that everything should be looked at through the lens of the consumer, because without the consumer, the industry doesn't exist.
May 20, 1998: FDA declared Pharmanex Inc.'s (Simi Valley) red yeast rice product Cholestin to be an unapproved new drug, sparking one of the earliest DSHEA-era court cases and setting the tone for many confrontations to come. According to FDA, Cholestin contained lovastatin, the active ingredient in Merck's (Whitehouse Station, NJ) Mevacor. But according to Pharmanex, Cholestin actually contained a natural metabolite of lovastatin. "If FDA says the product is a new drug," Pharmanex's former president told Nutritional Outlook, "then nothing will be safe under DSHEA."