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Industry Update 1994-2019

| January 2, 2019

Industry Update

Vitamin Retailer's 25 Years & 25 Top News Stories

The dietary supplement industry has gone through a number of changes since Vitamin Retailer’s (VR) debut in 1994. In honor of the magazine’s 25th anniversary, we looked back at 25 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 VR’s contributors and other experts what they consider the most significant events and how those events have shaped—and continue to shape—the industry.

1994

1.The Dietary Supplement Health and Education Act (DSHEA) passes.

“I well remember the incredible grass roots effort for getting DSHEA passed in Congress,” said Professor Gene Bruno, MS, MHS, RH(AHG), Huntington College of Health Sciences (Tennessee). “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.”

1995-1996

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, than 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 (cannabidiol) 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 says the drugs gets the monopoly.”

1998-1999

4. Washington, 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.

2001-2002

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.”

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. 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.”

2007

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

12. CRN launches its consumer wellness campaign, “Life…supplemented,” with the support of dietary supplement ingredient suppliers and product manufacturers. The multi-year, multi-million dollar public relations campaign focused on helping individuals create a healthier lifestyle by offering actionable suggestions and educational information about the three pillars of a smart wellness regimen: healthy diet, supplements and exercise.

2008

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

“It’s difficult to really comment specifically on each of VR’s top 25 news stories since the ones that covered regulatory milestones each had tremendous impact on our industry and our business over the years, specifically on how players should manufacture and market supplements while keeping consumers safe and instilling confidence in the products we sell,” said Bob Barrows, vice president of sales and marketing with Texas-based Bluebonnet. “The most notable of course were: the passage of DSHEA in 1994; to the final rule on structure-function claims in 2000; to the Food Allergen Labeling and Consumer Protection Act of 2004; to the AER reporting law in 2006; to finally the passage of the supplement GMPs in 2007—13 years after the passage of DSHEA. While the stories VR told about these new regulations were not news to Bluebonnet since we were always setting the quality and regulatory standards for others in the industry to follow, they did an excellent job illuminating the impact of these regulatory actions at the time. By putting these stories into perspective, they reassured readers that these new laws/regulations were necessary to ensure consumer confidence and safety in our products, to eliminate unscrupulous players, and to create a more even playing field.”

“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.”

2009-2010

14. Natural Products Association (NPA) announces that more than 300 natural personal care products have been certified through its two-year-old natural standard certification program.

2011

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

2012

16. AHPA (American Herbal Products Association), CHPA (Consumer Healthcare Products Association), CRN, NPA 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.

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

2013

18. 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

19. President Obama is asked to label GMOs (genetically modified organisms). Vermont’s governor signs GMO Labeling bill, which went into effect in 2016.

2015

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

21. 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

22. Federal GMO Labeling bill passage.

2017

23. Amazon buys Whole Foods for $13.4 billion.

2018

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

“If the amendment to the Farm Bill passes, it will be a great thing for the dietary supplement industry, and for the health and well-being of the public,” said Bruno. “CBD and related phytocannabinoids have significant value (see the article on CBD/Hemp Oil in the February 2018 issue of VR for details). Consumer interest in this nutraceutical continues to grow and show no signs of stopping in the near future.”

“Having been in the dietary supplement industry nearly as long as VR,” said Cheryl Myers, chief of scientific affairs and education with Wisconsin-based EuroPharma, Inc., “I can attest to the many changes that have occurred—some good, some not so good—over the past quarter century. Some of the good news is that the best companies continue to elevate their quality practices to stay abreast of issues with delivery systems, herbal substitutions, and illegal adulterations in an effort to provide consistently safe and effective products. On a darker note, some unscrupulous companies, found especially amongst those offering deceptive weight loss solutions and those riding the wave of CBD popularity, are entering the dietary supplement world without a full understanding of the many legal and quality issues that must be considered when launching products. Their illegal product claims that exceed structure function language are a challenge to all who are abiding by these regulations. They draw FDA scrutiny and allow the media to paint us as an irresponsible, fly-by-night industry, and nothing could be further from the truth.”

2019

25. Vitamin Retailer magazine celebrates its 25-year anniversary

“I appreciate VR’s role in providing quality information pertinent to our industry and value their integrity and devotion to the world of dietary supplements and natural medicines,” Myers said.

“For 25 years,” Barrows added, “VR has been a primary hub of just-time information on supplements from news to education and regulations to retail, so that key decision-makers in the business were informed from every angle. But most importantly from a brand perspective, VR has been an integral part of building the Bluebonnet brand and growing our brand awareness with vitamin buyers nationwide through a whole host of platforms. They have also enabled us to successfully introduce and showcase the science and unique selling features of our revolutionary, first-to-market products/brands over the years through unique editorial and digital opportunities like the Science of Supplements, Product Sales Trainings and email blasts. Plus, there were opportunities like corporate profiles—and being voted Manufacturer of the Year in 2006—for the story of our brand to be illuminated and our brand attributes like our commitment to being the most certified supplement brand on the market to be trumpeted to vitamin buyers so that they could understand the Bluebonnet difference and our premium-quality value in a sea of supplements. With all of these tools on top of our consistent back cover position and receipt of numerous Vity Awards over the years, VR has been an invaluable resource in making the Bluebonnet brand what it is today. So, as VR embarks on its silver anniversary, we toast their commitment to simultaneously building our business over the past 25 years as they have built theirs. They don’t just believe in partnership; they exemplify what it means to be a true partner.”

“Everything from the positive milestones to the negative events that occurred,” said Mister, “and things like CRN’s Life Supplemented campaign, and more recently the Supplement OWL (Online Wellness Library) Registry—having a line of communication to retailers, having that dialogue between the manufacturing community and the retailers who sell our products and the consumers who use them is so critical. I think VR—because you talk to audiences that maybe we don’t talk to within the industry, because you reach the retailers, you reach the store—you are a really valuable piece of getting the message out. Whether they were positive or whether they were defensive, VR plays a critical role for 25 years for allowing the industry to grow, because you made that connection between the industry and the retail side.”

“Happy anniversary VR, and all the fine folk who have made this excellent publication possible. When VR first launched,” Bruno said, “I remember thinking that Vitamin Retailer was a great name for a publication that was more specific to dietary supplements, and less focused on just foods. As I’ve seen VR evolve, it has continued to improve—the mark of smart planning that bodes well for the longevity of a publication. It has been my privilege to be a writer for VR since 2012, and I look forward to continuing in that capacity into the future.”

Vitamin Retailer's 25 Years & 25 Top News Stories

The dietary supplement industry has gone through a number of changes since Vitamin Retailer’s (VR) debut in 1994. In honor of the magazine’s 25th anniversary, we looked back at 25 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 VR’s contributors and other experts what they consider the most significant events and how those events have shaped—and continue to shape—the industry.

1994

1.The Dietary Supplement Health and Education Act (DSHEA) passes.

“I well remember the incredible grass roots effort for getting DSHEA passed in Congress,” said Professor Gene Bruno, MS, MHS, RH(AHG), Huntington College of Health Sciences (Tennessee). “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.”

1995-1996

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, than 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 (cannabidiol) 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 says the drugs gets the monopoly.”

1998-1999

4. Washington, 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.

2001-2002

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.”

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. 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.”

2007

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

12. CRN launches its consumer wellness campaign, “Life…supplemented,” with the support of dietary supplement ingredient suppliers and product manufacturers. The multi-year, multi-million dollar public relations campaign focused on helping individuals create a healthier lifestyle by offering actionable suggestions and educational information about the three pillars of a smart wellness regimen: healthy diet, supplements and exercise.

2008

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

“It’s difficult to really comment specifically on each of VR’s top 25 news stories since the ones that covered regulatory milestones each had tremendous impact on our industry and our business over the years, specifically on how players should manufacture and market supplements while keeping consumers safe and instilling confidence in the products we sell,” said Bob Barrows, vice president of sales and marketing with Texas-based Bluebonnet. “The most notable of course were: the passage of DSHEA in 1994; to the final rule on structure-function claims in 2000; to the Food Allergen Labeling and Consumer Protection Act of 2004; to the AER reporting law in 2006; to finally the passage of the supplement GMPs in 2007—13 years after the passage of DSHEA. While the stories VR told about these new regulations were not news to Bluebonnet since we were always setting the quality and regulatory standards for others in the industry to follow, they did an excellent job illuminating the impact of these regulatory actions at the time. By putting these stories into perspective, they reassured readers that these new laws/regulations were necessary to ensure consumer confidence and safety in our products, to eliminate unscrupulous players, and to create a more even playing field.”

“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.”

2009-2010

14. Natural Products Association (NPA) announces that more than 300 natural personal care products have been certified through its two-year-old natural standard certification program.

2011

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

2012

16. AHPA (American Herbal Products Association), CHPA (Consumer Healthcare Products Association), CRN, NPA 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.

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

2013

18. 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

19. President Obama is asked to label GMOs (genetically modified organisms). Vermont’s governor signs GMO Labeling bill, which went into effect in 2016.

2015

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

21. 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

22. Federal GMO Labeling bill passage.

2017

23. Amazon buys Whole Foods for $13.4 billion.

2018

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

“If the amendment to the Farm Bill passes, it will be a great thing for the dietary supplement industry, and for the health and well-being of the public,” said Bruno. “CBD and related phytocannabinoids have significant value (see the article on CBD/Hemp Oil in the February 2018 issue of VR for details). Consumer interest in this nutraceutical continues to grow and show no signs of stopping in the near future.”

“Having been in the dietary supplement industry nearly as long as VR,” said Cheryl Myers, chief of scientific affairs and education with Wisconsin-based EuroPharma, Inc., “I can attest to the many changes that have occurred—some good, some not so good—over the past quarter century. Some of the good news is that the best companies continue to elevate their quality practices to stay abreast of issues with delivery systems, herbal substitutions, and illegal adulterations in an effort to provide consistently safe and effective products. On a darker note, some unscrupulous companies, found especially amongst those offering deceptive weight loss solutions and those riding the wave of CBD popularity, are entering the dietary supplement world without a full understanding of the many legal and quality issues that must be considered when launching products. Their illegal product claims that exceed structure function language are a challenge to all who are abiding by these regulations. They draw FDA scrutiny and allow the media to paint us as an irresponsible, fly-by-night industry, and nothing could be further from the truth.”

2019

25. Vitamin Retailer magazine celebrates its 25-year anniversary

“I appreciate VR’s role in providing quality information pertinent to our industry and value their integrity and devotion to the world of dietary supplements and natural medicines,” Myers said.

“For 25 years,” Barrows added, “VR has been a primary hub of just-time information on supplements from news to education and regulations to retail, so that key decision-makers in the business were informed from every angle. But most importantly from a brand perspective, VR has been an integral part of building the Bluebonnet brand and growing our brand awareness with vitamin buyers nationwide through a whole host of platforms. They have also enabled us to successfully introduce and showcase the science and unique selling features of our revolutionary, first-to-market products/brands over the years through unique editorial and digital opportunities like the Science of Supplements, Product Sales Trainings and email blasts. Plus, there were opportunities like corporate profiles—and being voted Manufacturer of the Year in 2006—for the story of our brand to be illuminated and our brand attributes like our commitment to being the most certified supplement brand on the market to be trumpeted to vitamin buyers so that they could understand the Bluebonnet difference and our premium-quality value in a sea of supplements. With all of these tools on top of our consistent back cover position and receipt of numerous Vity Awards over the years, VR has been an invaluable resource in making the Bluebonnet brand what it is today. So, as VR embarks on its silver anniversary, we toast their commitment to simultaneously building our business over the past 25 years as they have built theirs. They don’t just believe in partnership; they exemplify what it means to be a true partner.”

“Everything from the positive milestones to the negative events that occurred,” said Mister, “and things like CRN’s Life Supplemented campaign, and more recently the Supplement OWL (Online Wellness Library) Registry—having a line of communication to retailers, having that dialogue between the manufacturing community and the retailers who sell our products and the consumers who use them is so critical. I think VR—because you talk to audiences that maybe we don’t talk to within the industry, because you reach the retailers, you reach the store—you are a really valuable piece of getting the message out. Whether they were positive or whether they were defensive, VR plays a critical role for 25 years for allowing the industry to grow, because you made that connection between the industry and the retail side.”

“Happy anniversary VR, and all the fine folk who have made this excellent publication possible. When VR first launched,” Bruno said, “I remember thinking that Vitamin Retailer was a great name for a publication that was more specific to dietary supplements, and less focused on just foods. As I’ve seen VR evolve, it has continued to improve—the mark of smart planning that bodes well for the longevity of a publication. It has been my privilege to be a writer for VR since 2012, and I look forward to continuing in that capacity into the future.”

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