Functional Ingredients: How has the passage of DSHEA affected your company?
"DSHEA has given our company guidance in setting the proper compliance standards for the manufacture of our vitamin and supplement products. Our compliance to these standards has made us a better company, and has helped us to grow in the 20 years since DSHEA passed."
– Jim Emme, CEO, NOW Health Group
"The lack of specific regulation was favorable to companies flying under the radar, or companies with the intent to make a quick dollar without fundamental respect for products or consumers. For those companies dedicated to building long-term cultures around quality products, defined regulation from DSHEA provided clarity and stability for developing and marketing products. The industry moved from fringe to mainstream, validated and supported by the equity and debt markets. Consumers, retailers, brands, management talent and investors aligned to create 15% to 25% growth from 1994 to 1998, and 7-8% thereafter. DSHEA became the most powerful catalyst to this growth." – Robert Reynolds, CEO, Arizona Nutritional Supplements
“The biggest impact was the opportunity to review the structure of our existing product labels. The passage of DSHEA required that we make some changes, but more importantly, it caused us to take a hard look at the most appropriate label format within the new law for the nature of our product. Our post-DSHEA labels were much more appropriate for our product and informative for our consumers.”
– John Blair, Senior Vice President, Juice Plus+
"As a retailer and active participant during the congressional lobby efforts for the passage of DSHEA, this legislation was looked at as a great tool to assure the consumer would have continued availability of good quality dietary supplements and to demonstrate to the FDA that we are an industry capable and willing to produce safe, high-quality products."
– Cheryl Dicks, MS, RAC, Director, Quality Assurance, Nutrasource Diagnostics Inc.
"When DSHEA passed I made the decision to focus my PR and marketing firm on products regulated under that law rather than the natural products industry in general because it was clear that a more defined regulatory framework would mean opportunity to specialize. Clearly the products we sell can have a positive impact on people's health, so the work is personally gratifying."
– Suzanne Shelton, Managing Partner, Strategic Communication, The Shelton Group
Functional Ingredients: How do you think the passage of DSHEA changed the dietary supplement industry?
"Those who were in the dietary supplement business before DSHEA was enacted 20 years ago will remember how the industry was under attack from FDA, which was seeking to impose unneeded restrictions on nutrient dosages, claims and ingredients. The positive impact DSHEA had on establishing a viable framework for the dietary supplement industry and ensuring consumer freedom of choice and access to safe nutritional products cannot be overstated. DSHEA was truly watershed legislation that continues to provide an effective model for responsible regulation of dietary supplements today and for the future."
– Paul Bolar, Vice President, Regulatory Affairs, Pharmavite LLC
"Prior to DSHEA there was very little regulation within the dietary supplement industry. During these pre-DSHEA years Congress was increasing the power of the FDA, which many feared would destroy the dietary supplement industry, making even vitamin supplements illegal to purchase over the counter. One of the main accomplishments of DSHEA was to deem supplements as an extension of conventional food, thereby providing some safeguards to ensure the survival of readily available dietary supplements."
– Nena Dockery, Technical Services Manager, Stratum Nutrition/ESM
"ANS was founded in 1996, after the passage of DSHEA. Our foundation of quality, integrity and service were forged with the expectation that consumers, industry and the government would continue to demand that dietary supplements were manufactured accurately, safely and as specified on the labels. At that particular time in the industry, there were many customers that were looking for a higher level of quality and service and we found a great niche in which we have continued to grow. Had DSHEA not passed, ANS might not have been able to flourish and grow into the quality leader in the industry that we are today."
—Aaron Blunck, Founder, Arizona Nutritional Supplements
"DSHEA has had a significant impact on the industry by distinguishing dietary supplements from food additives. This important milestone reminds us that DSHEA provides critical statutory authority to protect public health and guarantees the rights of Americans to have access to dietary supplements backed by science. BASF is proud to support DSHEA to ensure the safety and good manufacturing practices of dietary supplements sold in the United States."
– Ludger Eilers, Director, BASF Nutrition & Health, North America
"Over the past 30+ years I have been in this industry, as a retailer and consultant, I have watched the quality, the science behind dietary supplements and the integrity of this industry grow and expand." – Cheryl Dicks, MS, RAC, Director, Quality Assurance, Nutrasource Diagnostics Inc.
"The passage of DSHEA provided a lot of opportunity for manufacturers and related companies to build their businesses, as evidenced by the growth we've experienced. It also created opportunities for outliers to push the envelope for short-term gain, leaving the responsible core of the industry to clean up the mess they made." – Suzanne Shelton, Managing Partner, Strategic Communication, The Shelton Group
"The passage of DSHEA allowed vitamins to be sold freely in the United States without the need for prescriptions, and it also allowed for certain health claims to be made. DSHEA established the framework for setting up a specific regulatory framework for vitamin and supplement manufacturing standards, including cGMP requirements. These standards established a level of trust that has allowed our industry to grow in size and scope. DSHEA was a huge milestone event for our industry. Our industry is in fact regulated." – Jim Emme, CEO, NOW Health Group
"Clearly, the passage of DSHEA was a major step forward for the industry in terms of maturity and responsibility. It is an excellent example of government and industry working together based on a mandate from the general public. DSHEA demonstrated that our industry was serious about providing consumers with quality products and informative labels. – John Blair, Senior Vice President, Juice Plus+
Functional Ingredients: How has the passage of DSHEA benefitted consumers?
"DSHEA was a great achievement in providing consumers access to a wide array of dietary supplements held to the highest of standards. In developing DSHEA, the dietary supplement industry successfully partnered with legislators to establish clear guidelines and regulatory stability for the industry. It has allowed trusted retailers, like The Vitamin Shoppe, to offer an extensive assortment of vitamins, minerals and supplements and to educate our customers on their benefits."
—Tony Truesdale, CEO, The Vitamin Shoppe
"The passage of DSHEA and subsequent issuance of the Good Manufacturing Practices by the FDA, when blended with the statutory oversight provided by the Food Safety Modernization Act (FSMA), have done great service to the nation's consumers. What is now needed is for aggressive enforcement by the FDA and a cooperative effort with responsible industry to expose and prosecute those who willfully violate these statutes. Being able to properly craft truthful and non-misleading structure-function claims on supplements has provided the consumer with better clarity and understanding of product uses. Under the doctrine of unintended consequences, we have seen criminal behavior masquerading as dietary supplements, and enforcement and liability needs to be a guiding principle of the regulators in cooperation with responsible industry."
– Mark A. LeDoux, Chairman and Chief Executive Officer, Natural Alternatives International, Inc.
"The passage of DSHEA was a monumental achievement for both consumers and industry. It assured consumers freedom of access to safe products and gave industry an appropriate framework with which to work. However, we need to continue to educate our many stakeholders about DSHEA and encourage enforcement of its many provisions. For the past 14 years working with Congressional members and staff, I've also seen the great need to work toward the full implementation of DSHEA including GMPs and more."
– Carolyn Sabatini, Director Government Relations
"One of the best results of the passage of DSHEA is the use of structure-function claims on supplement labels. More consumers were educated by the structure-function application and it encouraged further investigation and research by consumers. Following the passage of the new law we saw the initiation of several online consumer and professional information sites consolidating scientific studies and structure function information on various nutrients into searchable applications. This increase in available information has led to increased usage of herbal supplements, up significantly in the general population since 1999 from 36% to 49% in 2013. The use of condition-specific supplements also increased from 21% in 2000 to 53%. In addition, concern about interactions between prescription medications and dietary supplements is down significantly from 52% in 2001 to 44%. The proliferation of information services and better labeling has provided a base of trustworthy knowledge to consumers who are now making more informed choices."
– Maryellen Molyneaux, President, Managing Partner, NMI (Natural Marketing Institute)
"DSHEA has provided a mechanism for the retailer to offer the consumer added assurance of receiving a good quality product by setting ingredient and manufacturing quality control standards for the industry. DSHEA has also given consumers the peace of mind that dietary supplements will continue to be available to them at these quality standards in the marketplace - a concern many consumers had prior to the passage of this landmark bill." – Cheryl Dicks, MS, RAC, Director, Quality Assurance, Nutrasource Diagnostics Inc.
"With the passage of DSHEA, the industry was provided with guidelines for the creation of better and safer supplement products. These guidelines were reinforced by the FDA regulations issued in 1998, designed to ensure that labeling of supplement products became more consistent and transparent, which helped the consumer better understand what was in the products they were taking." – Nena Dockery, Technical Services Manager, Stratum Nutrition/ESM
"Consumers have access to more products to support their health than ever before. The success of the industry has also allowed many manufacturers to fund research that results in more information and products to enhance health." – Suzanne Shelton, Managing Partner, Strategic Communication, The Shelton Group
"Consumers wanted DSHEA passed, and its passing was the result of an extremely large grassroots letter writing campaign, some saying it was the second largest letter event in the history of the US Congress. We believe consumers of vitamins and supplements have benefitted with better quality and safety under these regulations." – Jim Emme, CEO, NOW Health Group
"The passage of DSHEA was a great step forward in consumer protection and decision making. DSHEA provided a format for product information to be presented to consumers in a consistent and understandable way. As such, consumers were afforded a better basis for evaluating products on a comparative basis and making more informed decisions about product purchases." – John Blair, Senior Vice President, Juice Plus+
Functional Ingredients: Personal reflections? Any recollections to share?
“What we learned from being in the thick of leading the grassroots letter-writing campaign to achieve passage of DSHEA, is that those of us who believe that we should and can be responsible for our own health must remain ever vigilant if we are to preserve our right to access dietary supplements and control over our own health care decisions.” – Heather Isely, Natural Grocers
“Twenty-one years ago, FDA was beginning to treat dietary supplements like pharmaceuticals, despite a long history of safe and effective use, which was the catalyst for the industry to seek a more appropriate regulatory framework. I remember a town hall meeting at a trade show that launched industry efforts that was standing room only. The universal commitment to protecting the industry's ability to provide consumers with access to health-enhancing products was truly inspiring.” – Suzanne Shelton, Managing Partner, Strategic Communication, The Shelton Group
“At that time I was a retailer lobbying for DSHEA, doing radio spots to support the bill as well becoming an NNFA board member shortly after the passage. There was concern about the continued availability and freedom to purchase supplements. Regional Agency offices were reported to be taking supplements of concern off retailer shelves. As I teach my students in regulatory affairs, DSHEA marked one of the largest grassroots movements by the consumer to protect their access to dietary supplements and industry to step up and demonstrate the ability to self-police and provide the consumer with a safe, good quality product. It was a very exciting time!” – Cheryl Dicks, MS, RAC, Director, Quality Assurance, Nutrasource Diagnostics Inc.