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Industry Update 1995-2020

K2VITAL®
 
Albion Minerals®

Nutrition Industry Executive’s 25 Years and 25 Top News Stories

The natural product and dietary supplement industry has gone through a number of changes since Nutrition Industry Executive’s (NIE) debut in 1995. In honor of the magazine’s 25th anniversary, we took a look back at some of the industry’s major milestones, and reflect on the impact, challenges and evolution of the dietary supplement and natural products industry since the magazine’s inception. We also asked NIE’s contributors and other experts what they consider the most significant events and how those events have shaped—and continue to shape—the industry.

1995

1. One year since the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

“I well remember the incredible grassroots effort for getting DSHEA passed in Congress,” said Professor Gene Bruno, MS, MHS, RH(AHG), Huntington College of Health Sciences. “We collected thousands of signatures from people who shopped at retail vitamin stores. Almost everyone was behind it and rooting for its success. This particular issue had broad bipartisan support and is an excellent example of how all sides of the political spectrum can work together to achieve something that is important to their constituents, and truly beneficial to the health and wellbeing of the American public. To me, DSHEA was the critical law that helped take the dietary supplement industry to the next level in its evolution.”

1996

2. The White House Commission on Dietary Supplement Labels issues its report on future regulation of this product category.

1997

3. FDA (U.S. Food and Drug Administration) advised Pharmanex, the manufacturer of the Cholestin supplement, that the product was a drug requiring FDA’s approval. Counsel for Pharmanex maintained that red yeast rice was an ingredient with a documented history of food use.

Steve Mister, president & CEO of the Council for Responsible Nutrition (CRN), noted that FDA basically said if a drug was on the market first, then they get the monopoly on the product. If the supplement was on the market before the study of the drug, then the two markets have to share the ingredient. Supplements can make one set of claims for it and drugs can make disease-like claims. “We are starting to see more and more overlap as science advances,” Mister noted. “One example right now that is huge for the industry is CBD oil. FDA’s problem with CBD has nothing to do with the fact that it’s related to marijuana. FDA’s problem with CBD oil is around this provision with the Pharmanex case and the fact that if CBD was studied first as a drug before it was on the market as a supplement then this provision that says drugs get the monopoly.”

“This was the first major case of its kind,” said Darrin C. Duber-Smith, senior lecturer, Metropolitan State University of Denver, CO. “ The red yeast rice-based product was processed too far beyond its natural state, and according to the FDA, was considered a drug since another company already had a similar ingredient in the patent process. At least that’s the gist of it. Ultimately, marketing the product to pharmacists as a cholesterol reducer didn’t help the company’s case, and there are certainly lessons here for emerging CBD products.”

1998-1999

4. D.C. Circuit Court of Appeals handed down its decision in Pearson v. Shalala. A federal appeals court ruled in January that the FDA must allow “qualified health claims” on supplements—that is, claims that include qualifying language to prevent them from being misleading to consumers.

2000

5. FDA’s final rule on structure/function claims. Seen in general as a victory for the supplement industry, the FDA increased the number of claims that could be made for supplements and narrowed its definition of disease, rather than broadening it as the agency originally had intended.

2001

6. Following the Sept. 11, 2001 terrorist attacks, internet marketers and a few branded manufacturers touted supplements as remedies for bioterrorism. A coalition of industry groups issued a statement warning members to refuse to stock or sell products that were presented as anthrax treatments.

2002

7. Fish oil supplements garner serious consumer interest after the American Heart Association’s scientific statement on the benefits of fish and fish oil supplements for cardiovascular disease (CVD) is published in Circulation.

2003

8. Dietary supplements containing ephedra are banned Dec. 20.

“Few events have had such a profound effect upon the dietary supplement industry as the banning of ephedrine group alkaloids,” said Bruno. “Some companies ended up claiming bankruptcy, and others lost a significant amount of their sales. It was painful to watch—not only due to the financial harm it did to the industry, but because the decision to ban ephedrine group alkaloids was not based upon science, but rather upon politics—presumably to protect the public. True, there were people who misused these products, some of whom had heart conditions and shouldn’t have been using them at all (in defiance of label warnings) and so experienced ill effects, including—in a few cases—death. Nevertheless, when used correctly, many of these products had significant benefits, and it’s really a shame that they were banned.”

“The FDA’s line in the sand,” said Duber-Smith. “Described by some as an amphetamine-like stimulant that in small doses, makes for a good decongestant, but in larger doses raises blood pressure. The company I worked for in the mid-90s sold two such products and they were top sellers. Attributed to causing 155 deaths and at one point representing up to 62 percent of herb-related poison control center results, ephedra (ma huang) came to a very unceremonious end. The fear that dozens of other ingredients would follow, however, failed to materialize.”

2004

9. The Miller meta-analysis published in the Annals of Internal Medicine concludes that high doses (400 IU) of vitamin E daily could do more harm than good.

2005-2006

10. The adverse event reporting (AER) law is passed, requiring that companies submit serious AERs to the FDA.

“I think [this is] important for several reasons,” said Mister. “First of all, it amended DSHEA and it was the first time there was a really substantive change to DSHEA since it passed in 1994. So it showed that this law was not frozen in time and could never be touched.

“For a second standpoint, I think it serves as a model for how we can amend DSHEA in the future. There are conversations now, such as should there be a product listing or registry at FDA of products and there’s some concern about how do we do that without having the other side ask for things that we’re not prepared to give.

“The third thing that is really important is as an industry we said that we are going to allow FDA to see our adverse events. And at the time, that was even more than what drugs were doing. And I think we had a great ability over the last 12 years to point to that and say, look, this is an industry that really is very safe,” he said.

“This significant event represented solid recognition that nutritional supplements can have medicinal effects, which for marketers making structure/function claims, was really a good thing,” added Duber-Smith. “Adverse events mean that the stuff works, unlike magic potions and snake oil; and this sort of validation was a long time coming.”

2007

11. The final good manufacturing practices (GMPs) rules specific to dietary supplements are published.

2008

12. A three-year rollout of the Federal cGMPs (current good manufacturing practices) for dietary supplements begins.

“GMPs of course, really transformed the industry,” Mister said. “It took years before they were fully operational—they were fully applicable in 2010. I think having GMPs gives consumers assurance that the products are well made, and although we still have some hurdles—we still see FDA reports that some manufacturers are not 100 percent in compliance—we know we have some room to get better. But overall, GMPs are giving consumers a degree of assurance that they didn’t have otherwise.”

“It took too damn long, but a legitimate industry needs GMPs,” said Duber-Smith. “This event reminded me of the relative slowness of regulatory efforts compared to the speed of free enterprise, an unassailable truth to which our industry owes a great debt of gratitude.”

“GMPs have been a milestone for the industry for many reasons,” noted Joe Weiss, president of Nutrition 21 (Purchase, NY). “The manufacturing and testing of products is regulated by FDA to ensure safety, quality and efficacy. This is critical for consumer confidence and trust in dietary supplements. However, compliance has been uneven, and as the ABH recall has shown, brand owners need to be aware of regulations and do their homework to make sure their contract manufacturer is 100 percent compliant.”

2009-2010

13. NPA announces that more than 300 natural personal care products have been certified through its two-year-old natural standard certification program.

2011

14. President Obama signs the FDA Food Safety and Modernization Act (FSMA)

2012

15. AHPA (American Herbal Products Association), CHPA (Consumer Healthcare Products Association), CRN, NPA (Natural Products Association) and UNPA (United Natural Products Alliance) join together to call for an overhaul of the FDA’s Draft Guidance for Industry: Dietary Supplements: NDI (new dietary ingredient) Notifications and Related Issues.

16. The FDA announced plans to reissue a revised draft guidance NDIs used in dietary supplements.

2013

17. Scientists at NSF International and the U.S. Army Research Institute of Environmental Medicine publish a research paper confirming that 1,3 dimethylamylamine (DMAA) is not present in geranium and pelargonium species, or their essential oils.

2014

18. President Obama is asked to label GMOs (genetically modified organisms). Vermont Governor signs GMO Labeling bill, which went into effect in 2016 and was preempted by federal law two weeks later.

2015

19. Farm Bill allows for hemp to be cultivated for purposes of research

“This was a good start toward even broader deregulation of a very economically lucrative product category,” said Duber-Smith, “but industry acted a bit too rashly by allowing products into the supply chain that didn’t check all the boxes. Consumers rely on natural products retailers to be the gatekeepers of what’s natural and what’s legit, a key differentiatior for sure.”

20. The New York State attorney general’s (NYAG) office accused four major retailers of selling fraudulent and potentially dangerous herbal supplements and demanded that they remove the products from their shelves.

“I think the NYAG issue from 2016 was the closest thing to an existential crisis for the industry since ephedra,” Mister said. “That could have gone much, much worse for the industry. I have to pat CRN on the back a little bit because I think we were instrumental in diffusing that situation both with the media and the consumers by demonstrating that the DNA testing was flawed, that it was putting a round peg in a square hole. I think we did a really good job debunking this notion that DNA was the be all and end all test for supplements. It certainly kept other AGs from joining the lawsuit. They were trying to get other states to join with them and no one else did.

“We were able to recover from that,” Mister said. “Sales were back up. There was a little bit of a hiccup there, but they came back.”

2016

21. Federal GMO Labeling bill passage

2017

22. Amazon buys Whole Foods for $13.4 billion

“This acquisition was both a sign that e-commerce integrated brick-and-mortar stores are here to stay (Amazon is building many more) as well as an indication that the natural products industry might finally be maturing,” said Duber-Smith. “Recent chain closures like Lucky’s and Earth Fare are not a good sign, and an impending global recession will only usher in slower growth. Younger customers remain elusive, and natural products retailers are having a more difficult time than ever differentiating their brands from mainstream retailers that offer many of the same branded products in addition to non-natural brands they prefer. It remains to be seen what Amazon will ultimately do with Whole Foods, which still struggles with growth. Look for another big round of consolidation like we saw in the 90s as a sign that the industry has entered the maturity phase of its life cycle.”

2018

23. Hemp status gets update in U.S. Farm Bill proposal—will be removed from controlled substances list.

2019-2020

24. The World Health Organization recognizes the coronavirus outbreak as a pandemic on March 11, 2020. As the stock market plunged, natural product retailers, ingredient suppliers and product manufacturers adapt to a changed world, while striving to meet consumer demands, and keep staff members and communities safe.

25. Nutrition Industry Executive magazine celebrates its 25-year anniversary.

“I remember seeing Dan McSweeney (VRM Media’s publisher) in the booth at Vitamin Retailer’s (VR) first Expo (my third),” said Duber-Smith. “I was still at Zand Herbal Formulas, and we talked for a while. New Hope Natural Media, a company I worked with extensively on a consulting level, was right across the street from us and truly was the Goliath of the industry. In many ways it still is. I admired this David (Daniel) and have enjoyed both VR and NIE for many years. I am now a university business professor and an industry observer. This is my 800th media interview in the past 25 years, I’m happy to say that my first very first one was with Dan. It’s nice that we are all still here.”

Nutrition Industry Executive blazed a trail by offering suppliers like Sabinsa that have substance behind their ingredients a forum to educate brand manufacturers and marketers,” said Shaheen Majeed, president worldwide, Sabinsa, East Windsor, NJ. “Before NIE, there was far less opportunity to provide that information on a broad scale and to convey research on an ingredient’s safety and efficacy. NIE also allowed for a higher level of technical detail to be shared, since previously the publications were written for the entire industry, not just brands.

“Kudos to Dan McSweeney, who also launched Vitamin Retailer prior to NIE, which was the first trade publication to focus exclusively on the supplements side of the business. Dan has had a profound impact on the success of the industry through his publications.”

“Congratulations to the Nutrition Industry Executive team for celebrating this momentous anniversary!” said Sébastien Bornet, vice president global sales & marketing for Horphag Research USA Inc. (Hoboken, NJ). “Trade media is part of the foundation for advancing the nutritional supplement industry and serves as a vital tool for educating manufacturers and industry leaders on the trends and news making the most impact on the category. The Horphag Research team has been privileged to work closely with Russ Fields, Janet Poveromo and the entire editorial team for the last 25 years, and they have been pivotal partners helping our company, Horphag Research communicate on the science and advancements of our branded ingredients Pycnogenol and Robuvit. NIE is an important partner as we look forward to working together for the next 25!”

K2VITAL®
 
Albion Minerals®