Hot regulatory/legislative issues for 2013 and how to get your voice heard about them.
The pressure is on. You are charged with making an important decision about an issue that affects millions of people. Worse, you’re really not well versed on all its complex potential ramifications. Wouldn’t it be great to have a helping hand, someone knowledgeable to tell you what you need to know in 15 minutes and leave you with a clear one-pager to remind you about everything you discussed?
Such is the job of a lobbyist. These folks are educators and advocates for a group’s or an individual’s interests. While the job may seem intimidating, it’s something we all can and should do to ensure the concerns of the natural products industry are heard by lawmakers. This effort is important, since it often feels that our friends on the Hill are numbered, particularly given the upcoming retirement of industry champion Senator Tom Harkin (D-IA).
Issues to Watch in 2013
Numerous topics could be on the minds of elected officials in 2013 that will affect our industry. According to John Shaw, executive director and CEO of the Natural Products Association (NPA), Washington, D.C., the mood is right in Washington for some changes. “I think what we’re seeing is an active democratic Senate leadership that is looking toward affecting the dietary supplements industry one way or the other,” he says.
One big item on the table is the upcoming Government Accountability Office (GAO) report on adverse event reporting (AER), which was requested by Senator Dick Durbin (D-IL) and Congressman Henry A. Waxman (D-CA). Expected to be released in the first quarter of this year, the report has the attention of Mike Greene, vice president of government relations at the Council for Responsible Nutrition (CRN), Washington, D.C.
While no one can say for sure what will be in the report, Greene says it could mean a lot of extra work for dietary supplement makers. “The original law only required manufacturers to submit serious events. We suspect the U.S. Food and Drug Administration (FDA) will require all events,” he states.
This suggestion was included in the first GAO report, but the idea wasn’t popular. According to Greene, “FDA stated that they really did not have the ability to take in all AERs.”
Nonetheless, Greene and others believe in the AER system for dietary supplements. “At the end of the day, we should be watching to see what our products do,” he says.
Another area of potential concern for the first quarter of 2013 is the reintroduction of the Dietary Supplement Labeling Act, which could create a dietary supplements labeling database and direct the Institute of Medicine to make recommendations on warning labels.
In addition to these requirements, which some feel are unduly burdensome, the Act recommends FDA release a guidance on when a conventional food is not a dietary supplement, according to Green. “This all came about as a result of a brownie that had melatonin in it,” he explains. “That has now expanded, as there are a lot of concerns that Durbin is looking to focus on caffeine.”
Indeed, Durbin’s and colleagues’ attempts to influence FDA over its regulation of the energy drinks market is an issue being closely watched by many, including WholeFoods Magazine (see here, and here). “Durbin seems quite intent on having some kind of action, but we don’t know what it will be yet,” states Jack Martin, partner at lobbying firm Martin, Walker and Hatch, Washington, D.C. He points out that changes in labeling requirements in this segment are something to keep an eye on. ”That will be interesting to follow,” states Martin. “If it’s labeled one way, it’s a food; if it’s labeled another way, it’s a supplement.”
Besides labeling issues, there also could be some dangerous attempts to regulate beverage and supplement ingredients that have caffeine content. States Shaw, “We think it is very likely that there will be some sort of legislation intended to deal with this issue but will, unfortunately, open up the Dietary Supplements Health and Education Act (DSHEA). Protecting the integrity of DSHEA is of utmost importance for NPA—even though we’re coming up on 20 years, it still hasn’t been fully implemented.”
Martin raises the issue of the draft New Dietary Ingredients (NDIs) Guidance, which FDA is still sorting out how to revise. We could see further movement in 2013, and though things have been relatively quiet about it in recent months, work has been going on behind the scenes. “The NDI Draft Guidance is still in discussions, with the trade associations having had a couple of meetings so far with FDA over some points of contention,” he states.
Also of concern are genetically modified organisms. “The GMO issue is very complex,” says Shaw. “What we’re attempting to do is ensure the parameters of that examination regarding GMOs is done within a set box of principles that industry leaders can agree upon to ensure that lawmakers and decision makers are fully educated on our concerns.”
In the realm of the Federal Trade Commission (FTC), Martin is monitoring activity on POM Wonderful. He summarizes the issue at hand: “FTC is pushing for double-blind, placebo-controlled studies, which are essentially a drug-like standard…Everything FTC does as far as their regulation of the industry in advertising has impacts that I hope everyone in the industry is looking at.”
Several positive pieces of legislation also could come to fruition in 2013. First up is the reintroduction of the Designer Anabolic Steroid Control Act. According to Greene, “This legislation will give the Drug Enforcement Agency more authority to go after folks that may be manufacturing illegal anabolic steroids, and then have them masquerade as dietary supplements.”
Another change that could work in our industry’s favor has to do with flexible spending accounts (FSAs). “Currently, you cannot deduct spending on dietary supplements from an FSA without a doctor’s prescription,” explains Greene. Many believe this should be changed to allow the deduction of many self-selected dietary supplements for which there are many studies to support their benefits and allowable health claims.
“That’s good for the industry,” Martin believes. “You should be able to at least deduct the amount of money you spend on things that help your health.”
Group Effort? Go it Alone?
Natural Products Day 2013
Tuesday, March 19 is the Natural Products Association (NPA)’s Natural Products Day, a day to help industry members visit congressional offices and present info about legislation and regulatory activity that impacts our industry.
John Shaw, NPA executive director and CEO, says the agenda is based on members’ needs. He states, “We intend to establish some challenges and goals for 2013. It’s very fluid because you never know what the next day of advocacy is going to bring.”
The day starts out with an issues briefing and advocacy training session. Then, prescheduled meetings will be held with legislators, often alongside other Natural Products Day participants from the same area. An evening reception will honor congressional champions.
Says Shaw, “I think it’s very important that we work with members to go to elected officials to…make sure they understand how important dietary supplements are to everyday living in the United States.”
Now that you are excited or riled up about these issues, how can you express your opinions to elected officials?
According to Jarrow L. Rogovin, president/chairman of the board at Jarrow Formulas, Inc., Los Angeles, CA, too many companies and individuals sit on the sideline waiting for others to step up to the plate. He states, “Very few companies have even made a phone call to their Congress member, much less written a check or lobbied Capitol Hill. So, my first lobbying tip is that this company needs to get involved and organized. The hour is late.”
One of the easiest things a company can do to get involved in lobbying is to join a trade association and participate in lobbying events.
Shaw believes working as a group can be beneficial. “Having even an informal coalition of companies allows you to have a louder, more unified voice,” he states. “In NPA’s case, our grassroots action network has made our voice very loud and can be activated very quickly—both aspects giving us lobbying power.”
Carilyn Anderson, president of Carlson Labs, Arlington Heights, IL, also believes in a unified team effort, having participated in several group lobbying days before. While she says many of us in this industry are strangers to each other, a lobby day puts everyone on the same page. “We bring the same message to the Congress and Senate. The number of constituents we represent as a united front has more effect on the people that we meet,” Anderson believes.
Also speaking from experience in past group lobbying efforts, Jane Drinkwalter, vice president of sales at Vitamer Labs, Irvine, CA, believes going in it together gives the group better access to senators and representatives. “Saying we have a group of 100+ from our industry is powerful and gets us in the door,” she states, adding another benefit: “Our legislators can see we are a diverse group but hold the same values.”
What Congress Members Hate to Hear
Here’s what not to say in a lobbying meeting, as presented in a flyer prepared by Stephanie Vance, the Advocacy Guru (www.advocacyguru.com) and author of Government by the People.
I assume you know all about Bill XYZ. Since staffers are handling multiple projects simultaneously, they can’t be experts about everything. Give them all the information they need about specific bills.
We have to stand in the hall??? Sometimes, space is limited. Participate in your meeting wherever it is offered.
We have 10 people in our group. Since office space is small, keep your group to five people or less.
Here’s some reading material: our 300-page annual report. Limit the literature you leave behind to one or two pages.
I thought I was meeting with the Senator. Don’t show you are disappointed with a staffer meeting. This appointment can be just as important as a meeting with a representative in Congress. Staffers can make or break your cause.
Martin also says that an advantage of a group lobbying event organized by a trade association is having your day planned out by an experienced staff. Speaking of NPA’s Natural Products Day, he states, “When you get to the Hill, all your meetings are set up in a manner that lets you see your congressman and your senator.”
Companies may also want to go it alone in their lobbying efforts, and this certainly isn’t an enemy of group lobbying. “I think they co-exist productively at a higher level,” states Martin.
In agreement is Greene, who feels regardless of whether you go solo or in a group, “there is value in lobbying. Period.”
He explains lobbying is an ongoing process, not a one-shot deal. A company may attend a group lobbying day, go home and say, “Now what?” Continue the journey, says Greene, by encouraging your representative or senator to visit your facility or retail store.
Martin agrees, adding, “Get to know the people in your hometown. Go introduce yourself. Tell them about your business. Invite them to come by and see how you’re set up and explain what good these products do in keeping people healthy.”
This accomplishes something different than what may happen in a group visit on the Hill. Greene says CRN’s lobby days address overarching issues that affect the entire industry. A visit on your own turf, meanwhile, is the perfect time to address specific issues that directly impact your business.
Strategies for a Productive Meeting
When going about setting up meetings on your own, Shaw says many offices have a way to contact them through their Web sites. Or, one could send the office an e-mail that includes your name, where you are from in the district, and what you want to talk about, Shaw advises.
Don’t be surprised if you don’t get to meet with the Big Guy or Gal, and you’re scheduled with a staffer instead. “Senators and Representatives have their days chock full with maybe 10 minutes free each day, so one shouldn’t be discouraged if you are scheduled to meet with staff,” says Shaw.
This 20- or 30-something staffer, says Martin, often works 12-hour days for a small salary. “But, they love what they do and these are the people that the elected people rely on,” he says.
So, meeting with staffers is far from an effort in vein. Anderson explains that the staff member often does key research for his/her senator or representative. A brief written to his/her boss, using info from your meeting, will help the lawmaker make an informed decision. “Meeting the staff helps your company/store make an individual connection, making it possible for you to invite the representative to an event to meet his/her constituents and see what the natural products industry is all about,” says Anderson.
Drinkwalter says she has met with several staff members who are very knowledgeable and may even specialize in food/supplements issues. “They have better questions to ask us and can pass the specific and relevant points on to their senator or representative,” she says.
Top Lobbying Tips
Once you’re in the door, here are some tips for holding a meeting from those interviewed for this piece.
• Go into meetings with an agenda of two to three issues, advises Martin.
• Set the tone, says Drinkwalter, by being upbeat. Personalize your meeting, and be yourself. She states, “You are representing you and your company and your passion for our industry.”
• Keep things short and simple, says Anderson; 15–20 minutes will get the job done.
• Be patient, courteous, take turns talking and “remember, you’re not going to change federal policy in one meeting,” says Greene.
• And above all, Shaw says to always be truthful. This can be especially tough if you’re faced with a question you weren’t expecting. “It is always better to tell the member or staffer that you will get back to them later with an answer rather than feeling pressured to give an answer that you are not 100% confident about,” Shaw says.
After the meeting, leave some information behind. Many favor a one-pager, with Drinkwalter suggesting incorporating data on your key issues, details about you/your group, Q&As and information about who supports or opposes the issue. Greene says to put your material in a folder with your group’s name and contact information on it.
Don’t get thrown off your game if your meticulously prepared packet is politely refused. According to Greene, some members of Congress don’t accept paper in an attempt to be green, and want information to be emailed to them. “What you don’t want is to send an e-mail with information two, three days later when it’s no longer at the forefront of what they’re working on,” he says. “I’d even recommend having that email ready to go, so you can send it right from your phone.”
Once home, Anderson suggests following-up with e-mails and phone calls, and being persistent.
Rogovin says the worst thing we can do is to sit on our hands when faced with antagonistic legislation, regulations and even hostile media. On the latter, his advice is to be a leader: verify the facts and respond. He cites a recent attack on the dietary supplements industry for allegedly being reckless and unregulated by NBC’s Date Line and the Chicago Tribune. “No one checked the background and used it in defense of our industry except Jarrow Formulas,” he feels. “What Jarrow Formulas and its food and drug lawyers discovered is that it was the FDA that failed to act despite the fact that it is Daniel Fabricant who is misrepresenting a five-year-old story to attack the entire industry.” He said if the industry was more unified and organized as a group—and willing to challenge misinformation with fire—the outcome could have been different. Instead, he says, “Fabricant, the FDA, NBC and the Chicago Tribune got away with a cynical falsification and our industry got a black eye and a rant from Senator Durbin.”
While lobbying is only one part of getting our voice heard, Rogovin believes we should also consider the campaign finance side of politics, an area he doesn’t feel we currently have much pull. This means “getting the millionaires in our industry to part with a contribution and part of an afternoon or an evening with the politicians we need access to,” says Rogovin, noting too many people feel someone else will do it for them. “It doesn’t work that way,” he states.
Another thing the industry can do to get in the game is to start filing Freedom of Information Act requests (FOIAs), Rogovin says, “and to be willing to also finance the lawsuits to back them up and compel compliance with the FOIA by the FDA.” He says his company has used its own resources to file FOIAs to deal with aggressive action from Congress. WF
Published in WholeFoods Magazine, March 2013