Randy Dennin is an industry veteran who has been more influential in working for access to dietary supplements, and expanding and protecting the supplement business on a global scale, than perhaps any other individual. In 2002 the NNFA honored Randy with its Crusader award, which recognizes individuals who have made notable contributions to the natural products industry above and beyond commercial success. His many years with Capsugel provided a platform to work within, and several times create, trade associations that help keep us all in business and able expand operations overseas. He also has a heart of gold.
Your career has been so interesting. I remember you saying that you started your career in a warehouse, or something like that, long ago and by the time you retired from Capsugel you were VP of Dietary Supplement Business Development. Tell me about your career progression.
I began my career as a cleaner at General Mills. When I was 21 years old I decided to go to University, but had to do it over a period of ten years because I was married with three children. I began with Warner Lambert in 1970 in their consumer products division as Supervisor, and after several years became department head for the gum and mint section of the American Chicle division. In 1978, I moved to the Capsugel division of Park-Davis, which was part of Warner-Lambert, as a Production Manager in Detroit, where I was later promoted to Plant Manager. In 1980 I transferred to Greenwood, SC as Director of Operations for Greenwood, Detroit facilities and Brookville, Canada facilities. In 1983 I moved to Mexico as General Manager for Capsugelâs Latin American business, then moved back to Greenwood in 1986 where I was responsible for Greenwood and Brookville as Head of Operations. In 1987 I moved to Morris Plains, NJ where I served as VP of Global Operations. I moved back to Greenwood for the third time in 1989 as VP and Manager for the American region.
In the early 1990âs I began reading about supplementation, became interested in them and started using products. I was convinced that this area was beneficial for Capsugel because the two-piece Capsugel form is a very popular dosage form. In 1997, I moved into the newly created position of VP of Global Business Development for Dietary Supplements. I saw the need for the creation of the International Alliance of Dietary/Food Supplement Associations (IADSA), and involvement in Codex, because at that time Codex was near passage of a pharma standard. This last move also allowed me to spend more time on the regulatory issues in Japan.
Since retiring as VP of Dietary Supplement business development for Capsugel, I have remained on as a consultant to champion some of the initiatives that help provide more products to consumers around the globe. One of my key roles, for example, is Chairman of IADSA, which has grown to include 53 associations from 46 countries. IADSAâs efforts have contributed enormously in helping to grow the business for all companies in the industry. I also continue to serve on the Board of NNFA, chairing the Supply Committee. I am Chairman of NNFA Japan, which still requires a considerable amount of my time as we address some of the remaining issues regarding the regulation of dietary supplements. For the past year I have made a number of visits to China as there is an interest from American companies to have representation. We are therefore establishing a branch of NNFA with an office in either Beijing or Shanghai. I recently retired from the Board of Trustees of Bastyr University but have invested this time into other industry activities such as the formation of the Natural Products Foundation.
What are some of the changes you have seen in the span of your industry involvement both in North America and globally?
When I look back there has been much growth and consolidation within the industry.
From a regulatory point of view, we have not witnessed changes to DSHEA. We did go through a period where the FDA and the press attempted to convince the consumer that the industry is not regulated âwhich is not true. We still see some of that today but it appears some of it has subsided. It will be interesting to see what impact the new GMP regulations will have on the industry. My belief is that supplements are foods so the new regulations should be a reflection of food GMPs.
I anticipate that the Natural Products Foundation will address some of the issues such as false advertising and misbranded products. One positive is that the American government is investing monies into science, and hopefully this will have a positive impact on the consumer assuming the news on the science is good.
Over a period of time the associations have worked more closely together and the coalition to preserve DSHEA was a result of the coordinated collaboration of leaders in the industry and the associations. And the four major trade associations have been members of IADSA since its formation.
When did you start the International Alliance of Dietary Supplement Associations (IADSA)? What is the groupâs purpose and how does it operate?
We first got IADSA underway in 1997 when we recognised that a fundamental rethink was required on the global industry. Even though the issues we were facing across continents and countries were largely the same, there was at that stage very little sharing of information and little coordinated strategy and action. IADSA started as a small group of 21 associations and now brings together 53 associations.
Our goal has remained the same: to work with governments to create regulation that will bring safe and effective products to increasing numbers of consumers. Our challenge has been to support the numerous requests we receive from governments in Latin America, Asia and Europe. Much of the work that has been accomplished is the result of financial support we received from the company council.
What issues is IADSA currently addressing, and in what way?
Since IADSAâs inception, the range of work has grown enormously. As well as tackling the wide range of issues being addressed in Codex Alimentarius and the World Health Organisation (eg claims, additives, risk assessment, nutrition policy) we are working in more than 30 countries to help shape their national regulations. The issues we face constantly relate to whether supplements should be regulated as foods or drugs or somewhere in between. IADSA cannot dictate to governments what their regulatory systems should look like, but we provide information and guidance to indicate that most supplements can effectively be regulated under a food-based system. We provide information based on the science and the safety of supplements which helps demonstrate to officials that supplements can be regulated as a separate category of foods.
You were also very instrumental in starting NNFA Japan. How does that organization work and why was it needed? What is its relationship to NNFA in the US?
NNFA-Japan was created in the late 90s and was greatly needed as it is difficult for the local associations in Japan to have good dialogue with their government. We are an association of about 100 companies, twenty of which are from the US, two from Europe and the rest from Japan. A major focus of the association is to meet with the US and Japanese authorities to discuss further changes that we would like to see in the Japanese regulatory system. Our goal is to provide access to as broad a range of dietary supplements as possible so that the Japanese consumer enjoys the same benefits as we do in the US. All vitamins, minerals, more than 100 herbs and many other ingredients are now regulated under food law in Japan. Today, Japan is the second largest single country market after the US for dietary supplements. And, the market could easily double in size if we are able to convince the regulators that consumers need and desire information (structure and function) on the product labels.
Regarding the relationship to NNFA USA, NNFA Japan is a stand-alone association but we have regular dialogue with NNFA US and look for support from them. Each month our members receive a copy of NNFA Today and NNFA US meets regularly with US trade officials in Washington to discuss the issues in Japan.
As the industry matures, what do you see as the biggest threats or challenges that the industry must address to prosper, and how do we as an industry best tackle them?
The challenges we see from the regulators in the US are no different to those we face globally. Quality and safety are the important issues.
In North America, and specifically the US, we have challenges that are being addressed by the trade associations and the Coalition to Preserve DSHEA. Outside the US, our challenges are also opportunities since we have continued to see more and more governments seeking help and guidance from IADSA in their development of their regulatory models. The use of supplements is growing in most countries around the world, a trend that is expected to accelerate as regulations shift from restrictive to more consumer oriented systems.
As we have seen in the US, with less restrictive systems comes the need for more manufacturer responsibility. Dealing with quality issues and driving innovation will be at the heart of much of the work that the industry will be addressing in the future. We will also see more science become the basis for using supplements and I hope that we see the demise of those products, albeit limited in number, that create issues for us in the eyes of the consumer and the regulators. Problems with false advertising claims, misbranded products, adulterated products and products not complying with national regulations are not limited to the US. Industry needs to push regulators to address the problem. As an industry we should not be expected to regulate ourselves. Who would want to fly on an airplane if the aviation industry was expected to regulate itself? Government needs to work with industry to address this issue.
You personally, and Capsugel in general, have been singled out by some fringe groups as living proof that the supplements industry is controlled by a pharma cartel bent on having supplements become prescription drugs. When you do choose to respond, what do you say?
People should judge me on the results I have achieved in and for our industry. For example, Japan has gone from a reimbursement system for vitamins and minerals and no herbs allowed as foods and a ban on selling a conventional dietary supplement in a capsule, and tablet to a food-based system, with no restrictions on distribution or dosage form. Today the Japanese consumer has access to all vitamins and minerals, 100 plus herbs and other ingredients sold and regulated under food law. The Japanese can purchase their products in all of the typical dosage forms that we have in the United States, and the limits on distribution have been removed so that they can purchase their supplements outside of pharmacies.
You sit on the NNFA board of directors, which has clearly regained its industry leadership and relevance after having lost steam for a few years. What is next for this organization?
I never felt we lost our leadership. We had the challenge of replacing Michael Ford, industry consolidation and a downturn in the economy after 9/11. These all had an impact on NNFA that put some activities and initiatives on hold, but we have always been at the forefront for our industry. NNFA today has truly become an advocacy group with the opening and relocation of some staff to Washington DC. In addition we have formed a political action committee with more than 100 members, testified before Congress and government agencies, we are in the process of opening a branch office in Shanghai China, and established a coalition group to preserve and protect DSHEA. In 2005 we had the largest lobby day yet, which has been an on-going event since 1996. At NNFA we have restructured membership, which has increased the number of members by more than 40%. Our last three conventions have seen a marked increase in attendance each year. This year we will celebrate our 70th anniversary. These are some sizable accomplishments and with the current Board of dedicated leaders of our industry that we have, we will be moving further and faster.
Some have commented on the lack of emerging leaders in the industry, citing the usual suspects seem to always be on boards and committees. Do you agree? In our current environment, what qualities will it take to lead the sector over the next ten or so years?
We continue to need people with the energy, commitment and knowledge and a compassion for our industry. If you are not a believer and user, you are not going to be successful. My personal focus has always been aimed at initiatives that will benefit the consumer. I would hope that someday we will see products available to all consumers around the globe. Whatever it is we do in this industry, i.e., grow, produce, distribute, sell, regulate, etc. we should be able to link it to a consumer benefit. If we canât, we probably shouldnât be doing it.
Our industry needs more leaders who will put the industry ahead of their companyâs interest, recognizing that is the best way for a healthy marketplace. We need leaders who will work on making the pie larger verses growing their select slice of it. If the pie grows the industry grows.
What is next for you?
I will keep doing what I am doing as long as I see a need and I have the support from the industry globally. There is still much to accomplish and I like the challenge.
What do you hope people will say about you and your contributions to this industry 20 years from now?
One of the things I hope to hear is âWhen are you finally going to retire?â Whatever legacy I create should be asked from people that had either the opportunity or misfortune to work with me.