The history of the supplements industry entails a dance between FDA, FTC, Congress, trade associations and attorneys representing industry manufacturers. Several individuals figure prominently, but no one for as long as Robert Ullman. When NNFA bestowed its 2005 President’s award on Bob in July it was literally a lifetime achievement award – he joined the industry in 1961. He handled some of the landmark cases that have shaped the industry, allowing it to become what it is today.
You joined the firm that became Bass & Ullman in 1961. That firm was the NNFA’s general counsel for many years. What did your first exposure to our industry entail and what was your first impression? What was the industry like then?
When I joined Milton Bass in 1961, the firm was Bass & Friend. It became Bass & Ullman in 1969. One of the first matters to which I was exposed was FDA’s “first shot” at the vitamin regulations. We worked on objections to FDA’s Notice of Proposed Regulations. The regulations were so flawed that FDA was constrained to withdraw them, and it was not until the late 60’s that FDA started the process all over again. In those years, the industry was much smaller and narrower in scope than we know it today. Regional table top shows prevailed and the annual conventions were much smaller, the venues not so inviting (one show I recall wound up in a hotel garage), and many products did not taste all that good. But, a strong industry dedication from retailers, and the supply side as well, was always there – even if they did not always see eye to eye. FDA as the perennial common enemy was a unifying factor.
Has the industry always been susceptible to overblown fears like the recent Codex panic followed by the CAFTA panic?
Yes. There have been, and still are, those who look for opportunities to take up a battle cry, but having said that, I must point out that the question may be a little too harsh. Various governmental agencies and organizations here and abroad are continually sniping away at the industry, downplaying products, minimizing dosage levels, denigrating ingredients, and coming up with new “angles” aimed at impeding the industry’s forward progress. So it wasn’t wrong to react to Codex and CAFTA and to seek assurances that they would not interfere with the marketing of dietary supplements in the United States or lead to wider restrictions in the future. In these instances, a very good job has been done in monitoring and safe-guarding our interests. NNFA has been on top of it, CRN has been on top of it. Vigilant reaction is fine – it’s the overreaction that causes unnecessary and misplaced panic. Just remember what Henry Kissinger once said, “even paranoids have real enemies.”
You represented Metagenics in the FTC case against them about calcium. What happened? Why was this pivotal?
Metagenics ran a full page advertorial on the bone building benefits of calcium in consumer media. FTC saw it and decided to go after the company. Jeff Katke would not back down when he got a cease and desist letter. What really motivated FTC in the Metagenics case, other than blind arrogance of some misguided, ambitious lawyers, I still don’t know. I don’t think the company’s advertising was so widespread and prolific to deserve all the attention it got from the FTC in the first place. FTC’s concept was that the company lacked substantiation for the claim that calcium builds strong bones. My mother told me that calcium builds strong bones. More important, hundreds of articles in the well-established scientific literature and the testimony of one of the world’s leading calcium experts, Dr. Robert Heaney, M.D., told us that. While in the end the FTC prevailed on some minor points (which the company had offered to concede before trial), the company scored an overwhelming victory. The case was pivotal, in my view, in that it demonstrated that if the Commission is wrong, you can prevail – you don’t have to cave. Metagenics and CEO Jeff Katke stood up for what was right. Unfortunately, the cost in time, money and manpower can be devastating and that is what the Commission relies on in pursuing excessive demands.
In 1985 you handled a case before the 7th Circuit Court involving FoodScience that I have heard set the stage for the efforts that ultimately led to DSHEA. The concurring opinion set the stage for Traco and Oakmont – the Black Currant Oil cases – which prevented FDA from regulating many dietary supplements as food additives (which would require FDA pre-market approval). What happened here and why was it important?
In the FoodScience case, FDA didn’t focus on product claims that it believed to be false. Instead, they went after the product – Vitamin B15, variously called Pangamic Acid and Calcium Pangamate, “the great Russian formula,” – as an unapproved food additive that required prior FDA approval of a food additive petition before it could be sold. The company argued the product’s single active ingredient, N-N Dimethylglycine, was not a food additive but rather a food and, therefore, no food additive petition was needed. After about four years, FDA prevailed in the District Court and then in the 7th Circuit Court of Appeals, where the three appellate judges unanimously affirmed. But, one judge, Judge Cudahy, wrote a concurring opinion in which he said he would have gone along with the company if its advertising had not also touted the “benefits” of another ingredient in the product which the company argued at trial was just a binder or excipient.
Several years later, FDA brought another food additive proceeding – this time against Traco Labs’ black currant oil – on the theory that the black currant oil when sold in a capsule was an unapproved food additive, with the empty gelatin capsule containing the black currant oil being the food to which the black currant oil was added. In this case Traco’s president, Sid Tracy, carried the fight to FDA in the District Court, where Traco won, and on FDA’s appeal, in the 7th Circuit Court of Appeals where, (small world), Judge Cudahy was the presiding judge andTraco won again. In a similar scenario, FDA decided to take a second bite at the apple (or should I say the black currant) by filing another black currant oil seizure action in the First Circuit against Oakmont/Health From The Sun where, again, FDA was set back on its heels – first in the District Court and then in the Court of Appeals. In the 7th Circuit, the Court referred to FDA’s food additive theory as “Alice in Wonderland;” in the 1st Circuit, the Court said FDA’s theory “defenestrates common sense.” Later, when Congress was in the process of passing DSHEA, Senator Orrin Hatch specifically referred to these two cases as examples of why FDA had to be reigned in.
In the early 1970’s the FDA attempted to categorize high dose vitamins as drugs. The legendary A and D Case was precedent setting. Tell us about this, its impact and are there lessons we can use today?
Simply stated, the A&D case stood, and still stands, for the proposition that FDA may not arbitrarily and categorically declare a dietary supplement ingredient to be a drug simply because of the dosage level at which it is being marketed. This would have turned any dietary supplement into a drug at whatever dosage level FDA dictated, and likely a “new” drug requiring prior approval of new drug applications which would be prohibitively expensive and take years.
The A & D case also stood for the proposition that FDA and the Commissioner of Food & Drug must provide a thorough explanation of the basis and reasoning for such regulations. But, don’t get the wrong idea. FDA has plenty of authority to act against any products – foods and supplements alike – that are offered at unsafe dosage levels.
Rumor has it that you got the FTC to agree to use the money from a client’s settlement towards future cancer research. How did you manage that? Is there a chance you can get them to use future fines for supplement research?
I’m not completely sure. FTC was just beginning to seek seven-figure settlements and I said I wasn’t going to be known as “million dollar Bob” (today, that kind of bravado goes nowhere). A central issue in the case dealt with FTC’s position that the cancer research and literature relied upon by the company was inadequate and did not, therefore, substantiate cancer claims being made for the product. The company offered to expend a substantial sum of money on an NIH study that the company was contemplating and the FTC agreed. There was still a substantial monetary payment directly to the FTC, but it was not a million dollars. Eventually, the study had to be terminated for lack of subjects and the unused portion of the research funds were paid over to the FTC.
As to the chance of this ever happening again, I hate to say flat out “NO.” There’s always a chance – no harm in asking – but it’s highly unlikely. The Commission’s approval of the settlement was less than wholehearted and, subsequently, there were frequent expressions of lament among some Commission staff.
Are there one or two other pivotal cases you’ve been involved with that have been landmark? How so?
Early on, the Balanced Foods case was a very pivotal case in establishing the right of retailers to sell foods and maintain a book/literature section in their stores without running afoul of the Food & Drug Act. So important was this right that it was written into DSHEA with Congress saying that nothing in the statute’s prohibitions shall limit a retailers right to sell books.
Of course, another pivotal case was the Second Circuit’s decision in 1974 striking FDA’s vitamin regulations. Judge Friendly’s decision was a landmark victory for the industry, putting the brakes on attempts by FDA, the medical establishment, and the drug industry to muzzle the dietary supplement industry in giving useful information and providing useful, nutritional products to an emerging health-conscious public.
Certainly, these cases drew some lines, which, even today, FDA knows better than to cross.
Given your history, what kind of shape do you think the industry is in today? For industry to thrive, what do you think we need to do? Have you ever second-guessed your commitment to the industry?
On an overall basis, the industry today is in good shape. Compared to 20 or 30 years ago, its foundation is more solid, it is in the mainstream, it has a high quality leadership organizationally and in its media, and the trade associations are stronger. Industry members – retailers, distributors and manufacturers as a whole – and the consuming public -- are all more nutrition educated and knowledgeable.; nutritional concepts of complimentary and alternative medicine have taken hold. We have more friends and supporters in Congress, and regulatory agencies have come to recognize the industry as having grown into a formidable force to be dealt with greater regard than in the past. .
But, for the industry to thrive, it must strive for continued improvement in its manufacturing, marketing, and product development practices. Good science is needed to support new products and to substantiate product claims. Effective self regulation to demonstrate the industry’s ability to govern itself could go a long way towards mitigating the need for perpetual governmental intervention. Unfortunately, “self regulation” has become something of an oxymoron. Self regulation without compliance and enforcement is no regulation at all.
Have I ever second-guessed my commitment to the industry? NO! It’s not my nature. I have been at it for over 40 years. But, in individual situations, it’s been more than once that I’ve felt compelled to ask myself, “When will they ever learn?”
What has been the worst moment of your professional life? The best?
Aside from some unfortunate personal moments in my professional life, the biggest disappointments have come in cases in which I felt the law was on our side but a court, motivated by it perception of the facts and a leaning towards the government, ruled the other way. I don’t like losing in any event and sometimes bad facts make bad law.
Two examples come to mind. A few years ago FDA decided it could impose new safety packaging requirements on iron supplements, when Congress had clearly and expressly taken that authority away from FDA and transferred it to the Consumer Product Safety Commission. Challenging FDA’s regulation was an “easy case.” But after sitting on the case for about two years, the District Court ruled in FDA’s favor. That was disappointing – and wrong. Fortunately, the Second Circuit Court of Appeals reversed – striking FDA’s illegal grab of authority in a decision that for some unexplained reason did not get the recognition it deserved for spelling out that FDA cannot get away with ignoring the law and over-riding Congress.
Another example is a more recent decision by a federal judge in New Jersey granting FDA’s request for an overly-broad injunction and for severe monetary penalties in the form of restitution and disgorgement. Disappointingly, the court rejected well-founded arguments that such penalties are clearly beyond the scope of the remedies Congress provided in the Food & Drug Act. An appeal is pending.
On a personal level, receiving the NNFA President’s Award was truly a gratifying moment. In the legal arena, a “best moment” came when, on the eve of the Traco trial, the judge called us up to the bench and announced he was granting our motion for summary judgment dismissing FDA’s case. We accepted that announcement with dignity and grace, but when we hit the street outside the courthouse, I let out a “yahoo” that could have been heard from Danville, Illinois to either coast. When the 7th Circuit affirmed that ruling, it was yet another fulfilling moment.
What do you think is the industry’s biggest failing? Greatest strength.
Greed is not a nice word. So I won’t use it. But there are too many instances of prematurely running to get on the market with something new before the evidence is in, making drug claims your lawyer would not approve (not to mention FDA) for supplements in order to sell more product, failing to have substantiation to support product claims before making the claim, relying on narrow and limited test results or studies and reports to make broad, generalized claims without having the science to back it up. Shoot first, ask questions later. Perhaps I shouldn’t complain – these things are good for lawyers, but not so for the long term good of the industry. And you know what one bad apple can do to the barrel.
On the other side of the coin, the industry barrel does have many good apples. The industry has the grit to stand up for what it believes. It has capable leadership and a dedicated membership that believes in what they are doing. The increased recognition of complementary and alternative medicine has served to enhance the industry’s credibility (NIH now has a separate division for CAM). The growth of the industry and a greater acceptance of its teachings is, in itself indicia of its strength. After all, there is strength in numbers.
Is it possible for industry to proactively work with the FDA and FTC? What needs to happen?
It is not only possible to proactively work with the FDA, but a necessity. With respect to FDA, I think it’s a work in progress. It is folly to think you don’t have to work with your regulators. Our trade associations have worked hard to open and maintain lines of communication on serious issues affecting the industry. It requires some mutual understanding, compromise, listening, and the ability to not always “just say no.” Credibility in what we do and what we say can go a long way – that goes for both sides. To get there, we need more good science and a little self-restraint. And, industry members should be alert to FDA notices of proposed regulations and participate in the process by submitting timely comment. This is clearly one way to impact the regulatory process.
With the FTC, it’s a slightly different story. FTC regulates on a company-by-company basis. It targets what it perceives as false claims by individual companies who are individually accountable for their own advertising claims. As a practical matter, there is little room for group therapy to work with the FTC. That does not mean that the industry should not be more proactive in reacting to the wild claims and lavish promises. This it could do by fostering and monitoring truth in advertising from within, but perhaps that is being overly ambitious.