© Whole Foods Magazine

October 2003

 Bringing the FDA into Compliance:
Part 2: Action is the Price of Freedom
An interview with Jonathan Emord, Esq.

 by

Richard A. Passwater, Ph.D.

 

Please permit me to paraphrase Thomas Jefferson and others who have been credited with having said “Eternal vigilance is the price of freedom.” Irish politician John Philpot Curran, who in speaking on the Right of Election in 1790 purportedly said, “It is the common fate of the indolent to see their rights become a prey to the active. The condition upon which God hath given liberty to man is eternal vigilance; which condition if he break, servitude is at once the consequence of his crime and the punishment of his guilt.”

While the popular quote is true, I prefer to express it as “Action is the price of freedom.” Vigilance means to be watchful and attentive, but unless we carry through we will lose the freedoms that made this country what it is. It is once again time to take action to protect our health rights. If you leave this task to others, you may very well get what you would then deserve-the loss of the privilege to choose to optimize your health with appropriate dietary supplements. Others have fought for your rights in the past. Now it is your time to come to the fore.

As we were chatting last month with Jonathan Emord, Esq., several critical developments began emerging that may have tremendous impact on the ability of consumers to have access to dietary supplements they need for optimal health and quality of life. Once again, the health food movement may be reaching a critical juncture in its history-where current developments may reverse recent gains in consumer health choices reverting back not only to the days before the Dietary Supplement Health and Education Act of 1994 (DSHEA), but to the conditions that prevailed before the 1970s and the passage of the Proxmire bill.

Although on the surface, there appears to be little turmoil at this time, changes are being proposed that can affect each and every one of us. The Food and Drug Administration (FDA) is about to impose good manufacturing practices (GMPs) that are not in the consumers’ best interests; the FDA is changing its procedures for allowing health claims; Illinois Senator Richard Durbin, a Democrat, has introduced a bill to weaken DSHEA; and Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA) have introduced a bill to fully fund the FDA in enforcing DSHEA to protect consumers.

It is against this unsettled background that we continue our discussion with Constitutional rights attorney Emord.

Passwater: A few sensationalistic reporters seem to regale in deriding the health food industry as being “unregulated.” Are dietary supplement manufacturers unregulated?

Emord: Dietary supplement manufacturers are inspected at random by FDA field agents who arrive unannounced, sometimes take product samples for testing and evaluation, usually take product literature for evaluation, and usually ask numerous questions about the manufacture and distribution of products.

Those found to engage in the manufacture of adulterated or unsafe products are sent warning letters, ordered to discontinue sale of the products, or are prosecuted. Those found to have labeling that is false or misleading or that includes unauthorized nutrient-disease claims are likewise subject to warning letters or prosecution. This past year FDA has sent out more warning letters than ever before and has announced that it will be vigilant in prosecuting parties for false and misleading claims. The FDA is also contemplating adoption of new regulations, cGMPs, for the manufacture, holding, and distribution of supplements that threaten over 80% of existing dietary supplement companies with extinction. The regulations are cost prohibitive for all but the largest firms. In sum, far from being unregulated, the industry suffers from too much regulation.

Passwater: Are health food retailers unregulated?

Emord: Health food retailers must abide by the laws that prohibit sale of products that present a significant risk of illness or injury. They must also abide by the labeling laws and prohibitions against health claims.

Former FDA Commissioner David Kessler dispatched several hundred undercover FDA field agents to health food stores across the country. Kessler believed those agents had substantial proof of unauthorized claims and reported the claims and that conclusion to Congress. Senator Hatch’s staff later established that many of the submissions made by Kessler were not capable of corroboration or were contrary to evidence obtained by the senator’s staff.

Nevertheless, the fact that this happened reveals that FDA has the power to do it again. Like manufacturers, retailers are indeed subject to FDA’s jurisdiction and may be inspected unannounced and at any time.

Passwater: Does the FDA have adequate authority to protect consumer health now?

Emord: FDA has ample authority in the Food Drug and Cosmetic Act to take immediate action to halt the sale of any food, dietary supplement, drug, biologic, or medical device that poses a threat to public health. The act permits the FDA to act unilaterally in an emergency, to obtain injunctive relief, to quarantine and condemn inventory, and to prosecute parties responsible for harm to the public under civil and criminal provisions of the act. The notion that FDA needs more power to do its job properly is mistaken. FDA Commissioner Mark B. McClellan does not complain of a lack of authority; rather, he has been saying that the agency has the authority it needs to prosecute law violators and intends to use it.

Passwater: Why doesn’t the FDA enforce the regulations that are already in force?

Emord: In the past, FDA has often acted for political, rather than legal or true health and safety reasons. Under Commissioner Kessler, much of the agency’s time and resources were spent on trying to limit the availability and claims made for dietary supplements. Certain high-profile prosecutions were initiated but many real instances of fraud and harm to the public went unaddressed. The new commissioner appears to be making headway in redirecting FDA’s enforcement away from the patently political toward arresting instances of actual harm in the market. While that change is a welcomed one, whether it will translate into a true redirection in FDA enforcement depends in large measure on whether career bureaucrats responsible for agency enforcement get the commissioner’s message and implement it faithfully or whether they frustrate his intentions.

Passwater: Why does the FDA claim that it needs more regulations?

Emord: The present FDA commissioner does not complain of a need for more regulatory power. His immediate predecessors did, and many in the FDA bureaucracy do. Nobel laureate James Buchanan, an economist at George Mason University, won the Nobel Prize for his public choice theory. He said that bureaucrats, just like people in the private sector, pursue their own self-interest (through the mechanisms of government). So they endeavor to increase their authority, position, responsibility, power, and wealth by crying for more laws to fight essentially the very same problems that are addressed by existing laws. Budgets always increase, existing departments always expand in size, new departments always seem to be created, career civil servants rise higher up on the totem pole and their salaries increase; it’s the story of Washington politics: government never really gets smaller.

Passwater: Do you think that Senate Bill S 722, the so-called “Dietary Supplement Safety Act” introduced by Senator Richard Durbin of Illinois will improve consumer health and safety? Does it offer more consumer protection over DSHEA?

Emord: No. It will likely not improve health and safety one iota. The dietary supplement market is safer than the food market and far safer than the drug market. Drugs harm about 226,855 people per year and kill about 1,418 people. Foods kill about 5,000 people annually. Supplements are attributed with about 12 deaths a year (making them the safest ingestible products on the market). It is extremely difficult to make a market characterized by such a high level of safety safer through the adoption of yet another federal law. FDA already has the authority that Senate Bill 722 would grant it. FDA can remove, seize, condemn, and destroy products that are misbranded, adulterated, or otherwise present an unreasonable risk of harm to the public. Under the Dietary Supplement Health and Education Act, a manufacturer cannot lawfully market an unsafe dietary supplement. If FDA determines that a product or ingredient in the product is unsafe, it has statutory authority to remove that product or ingredient from the market. There is no need for Senate Bill 722. It is regulatory overkill.

Passwater: Will it fundamentally alter the way dietary supplements are regulated and unnecessarily expand FDA authority over dietary supplements? Would it significantly undermine many of the freedoms of consumers?

Emord: Senate Bill 722 would amend the Food Drug and Cosmetic Act to require manufacturers of dietary supplements and packers and/or distributors whose names appear on the label of a dietary supplement to report to FDA serious adverse experiences associated with consumption of the supplement. The bill would require that those individuals and entities develop written procedures for surveillance, receipt and evaluation of the information concerning adverse dietary supplement experiences. Upon receipt of a report of a serious adverse experience, manufacturers would be required to investigate the incident and report it to FDA as soon as possible, but in no event later than 15 days after obtaining the information. FDA would then conduct its own investigation and could require the manufacturer/distributor to provide the agency with safety evidence in support of the product. If FDA were not satisfied by this evidence, it would be authorized to remove the product from the market.

The bill unfairly presumes that anyone who alleges a serious adverse effect from a supplement does so truthfully and that the burden should be on the company that makes the product to prove that the charge is untruthful by expending money to that end. Under current law, FDA has the burden to prove a dietary supplement unsafe before the product may be removed from the market. Current law is preferable because it limits costs on producers of products to those instances where good evidence exists of harm. No one should have to expend tens of thousands of dollars with lawyers and scientists to prove a safe product safe because someone (perhaps even a misguided competitor) makes a false charge of injury. Only when the injury is reasonably traceable to the product should the company be concerned. The present law ensures that FDA will not act on every complaint but can exercise discretion to determine which complaints are genuine and present credible evidence of harm. The Durbin bill increases costs, ultimately to the detriment of consumers, without justification.

Senate Bill 722 further amends the Food Drug and Cosmetic Act by defining the term stimulant. A stimulant is any dietary ingredient that has a stimulant effect on the cardiovascular system or the central nervous system of a human by means of speeding metabolism, increasing heart rate, constricting blood vessels or causing the body to release adrenaline. If passed, all stimulant-containing dietary supplements would be subject to FDA pre-market approval. That would effectively remove several relatively safe supplements from the market, including all manner of supplements that contain caffeine in an amount no higher than a cup of coffee.

If passed in its present state, Senate Bill 722 will undermine consumer choices and is excessively paternalistic. It will add unnecessary expense to manufacturers and distributors of dietary supplements. In cases where FDA suspects that there is a reasonable possibility that use of a supplement will injure consumers, it already has the power to engage in market surveillance. The new bill is redundant, and it is more expensive for the government and the regulated industry than the present law.

Senate Bill 722 could well reduce consumer health. Because the bill would likely increase the costs of supplements and decrease the number and kinds of supplements available, consumers now dependent on certain products for good health may find it more difficult, if not impossible, to obtain them in the future.

Passwater: Is there anything that consumers should do to correct this? Is there still time?

Emord: It would be a good idea to oppose this bill by addressing a letter, e-mail, fax, or phone call in opposition to it to your congressmen and senators. The National Nutritional Foods Association (NNFA) has made this easy on its web site-www.nnfa.org. Congress was out of session for much of the summer, so it may still not be too late to oppose the bill. When we last checked (in August), the bill had not yet been put on the Congressional calendar for consideration.

Passwater: On the other hand, Senators Hatch and Harkin have introduced a Senate bill called “DSHEA Full Implementation and Enforcement Act” to facilitate full implementation of DSHEA. The bill calls for greater enforcement of DSHEA by increasing funding for FDA and the National Institutes of Health’s (NIH’s) Office of Dietary Supplements (ODS) so that the agencies can fully implement DSHEA. The bill would increase the budget for the ODS, which was created by DSHEA to expand research and provide consumer information on dietary supplements, to $30 million from $20 million and appropriate $205 million to FDA during the next five years. Would passage of this legislation end the misinformation in the press by some writers and take away the FDA excuse?

Emord: I am not a fan of any new legislation except that which would reduce regulatory restraints on freedom of informed choice in the market. It may be that Senators Harkin and Hatch have determined that the best way to kill Senate Bill 722 is to offer a substitute that does no harm. The Hatch/Harkin bill, S.1538, increases funding for FDA enforcement. It also increases funding for the Office of Dietary Supplements at NIH, which is principally a research entity.

As the above answers indicate, the problem with FDA enforcement lies in the expenditure of existing resources on matters that are not true public health problems. Throwing more money at FDA will not, I think, redirect agency efforts and will likely exacerbate problems until the day arrives when enforcement is redirected. The best hope for this redirection in the short run is Commissioner Mark McClellan. He is sincerely interested in protecting freedom of informed choice in the market and directing enforcement efforts at real, rather than imaginary, public health threats. We very much hope he succeeds, but do not think he needs more money to do so.

Passwater: I believe the health food industry is supporting this Hatch-Harkin bill. Will that send a message to the public that the health food movement is serious about public health and safety?

Emord: I think the principal way the public will come to understand the importance of dietary ingredients to human health is through educating them about the wealth of science on the nutrient-disease relationship at the point of sale (i.e., through FDA approved or allowed health claims). Just as information about folic acid reducing neural tube defects has saved thousands of children from that horrible affliction because so many women today know of the need to take .4 to .8 mgs of folic acid daily to reduce the risk by 40% or more, we expect the emerging health claims on a number of disease risk-reducing nutrients (e.g., omega-3 fatty acids and coronary heart disease; vitamins B-6, B-12, and folic acid and vascular disease; and glucosamine and chondroitin sulfate and osteoarthritis) will cause the public to appreciate just how important a wide variety of nutrients are to human health. When people come to realize more than they do today that hundreds of thousands of lives have been saved through increased consumption of certain health-enhancing and disease-reducing supplements, they will find the arguments of harm germane not for supplements in general but for only a few ingredients or, more likely, only a few bad actors. In that way, the public will shift to favor pointed enforcement against individual wrongdoers, which is the least costly and most effective way.

Passwater: Last month you commented on the FDA’s proposed guidelines on good manufacturing practices (GMPs). The comment period ended on August 11. What are some of the concerns expressed to the FDA?

Emord: The proposed cGMPs impose restraints and costs on the entire industry, purportedly to prevent the manufacture of adulterated products, a condition that is the rare exception in the market. The effect is to saddle all companies, the good majority and the bad minority, with huge new costs.

If the proposed cGMPs are not modified, they threaten to eliminate a large number of firms that have no prior history of selling dietary supplements or dietary ingredients that have harmed consumers, particularly small firms ($5 million in annual revenues or less, comprising about 88.9% of the market) and intermediate sized firms ($5 million to $99 million in annual revenues, comprising about 9.2% of the market), and to enhance the market position of large firms. The small and intermediate-sized firms lack the financial wherewithal to make all of the changes the new rule would require, including, for example, new plant design and construction, the hiring of new personnel and the institution of new personnel training, and extensive new batch testing of materials previously tested by source manufacturers.

In the end, if the rule is not changed significantly, it will drive out a lot of companies, suppress much innovation, tend to increase supplement prices, and will have little, if any effect, on supplement safety. The new rule, like existing law, cannot stop a person who is intent on selling an adulterated product or on manufacturing in a negligent or irresponsible manner. It can only get them after the fact, as do existing laws. So, bad actors will not be stopped. The level of harm in an already largely safe market will diminish, if at all, only by a modest amount; yet the economic injury to the industry, to innovation (even innovation in the development of new safety controls), and to the survival of small and intermediate sized firms will be very great indeed. Our clients have filed comments advocating significant changes in requirements and methods to reduce costs without compromising safety.

Passwater: What effect would you foresee for the consumer of dietary supplements if both the Senate Bill S 722 and FDA’s GMPs went into effect as they now stand?

Emord: While none of us can tell for sure what the future holds, I would guess that supplement prices would increase to some extent, there would likely be fewer supplements on the market over time, innovation in the supplement market would likely diminish, and fewer products would likely be available to consumers. In short, the industry would probably suffer first, and consumers would suffer thereafter.

Passwater: Also, last month, we discussed the final report and recommendations of the FDA’s Task Force on Consumer Health Information for Better Nutrition. This task force was established to help American consumers obtain “accurate, up-to-date, and science-based information about the health consequences” of foods and dietary supplements. The FDA issued “guidances” for industry outlining the petition process for obtaining approval to use qualified health claims and how such petitions would be evaluated. In addition, the task force discussed the critical need to encourage and help consumers to make better nutrition choices. Do you think that this new approach is helpful?

Emord: The new approach looks fine on paper, but the proof of it lies in how the agency implements the plan. In the end. FDA must accept the First Amendment requirement that government favor disclosure over suppression as the rule and limit its use of censorship to those extremely rare instances when the words to be communicated are inherently misleading (incapable of being rendered non-misleading through the addition of more information). If FDA gets that message, which comes from the federal courts in response to the legal challenges by Durk Pearson, Sandy Shaw, Pure Encapsulations, Inc., Dr. Julian M. Whitaker and others, it will implement the letter of the new rule in the spirit of the First Amendment. If it does not get that message, it will proceed like the former Soviet Union did in interpreting the civil rights protections of the Soviet Constitution: The First Amendment will be rendered meaningless and civil rights will be violated.

Passwater: How does it work? Will it allow health claims (information) for important nutrient benefits that were not allowed to be put on the label before?

Emord: It implements the Pearson decision. Instead of suppressing a claim because it is not proven to a near conclusive degree, it will allow the claim with a disclaimer that alerts the consumer to the fact that the evidence is not conclusive. In short, far more claims will reach consumers along with qualifications stating the level of support in the science.

Passwater: Should this be extended to information about nutrient-disease relationships as well?

Emord: The qualified claims apply directly to nutrient-disease relationships. They are designed to be used in all instances when a health claim petition fails to satisfy the “significant scientific agreement” standard. Claims not satisfying that standard will be allowed nonetheless with disclaimers under the qualified claim regime the agency has adopted.

That regime is a direct response to the Pearson court’s command that FDA follow the First Amendment and allow qualified claims as a less speech-restrictive alternative to suppression of claims that do not satisfy FDA’s significant scientific agreement standard. In point of fact, the so-called SSA “standard” is still largely undefined and, so, not a reasonable “standard” by any means.

Passwater: What have been the objections to this improved disclosure of factual and non-misleading information? Are these objections reasonable?

Emord: Some have said that consumers are incapable of understanding science and will view claims backed by credible, but not conclusive evidence in the same manner as claims that are backed by conclusive evidence. I think that view unsound, highly paternalistic, and in any event contrary to the principles of our First Amendment. The First Amendment protects the right of the speaker to convey a truthful message, regardless of whether the listener understands the message, and the listener has no right to constrict the truthful message of the speaker. The listener’s rights are contingent on those of the speaker (the listener has a right to receive the speaker’s message). In fact, a health claim when first released in the market is likely the subject of significant misunderstanding. That is the nature of complex information in all markets. There will be debate over the meaning and validity of the claim. Consumers will participate in that debate and, over time, through the debate there will come a general understanding. The First Amendment guarantees us the right to have that open idea and information market operate free of government censorship.

Passwater: Well, thanks to your efforts, the FDA is in a position where it must obey the Constitution. You also have other efforts in process. What should we be looking for in the battle for freedom and  constitutional rights?

Emord: Our clients have filed a petition with the Federal Trade Commission (FTC), demanding that the commission change its approach to deceptive advertising enforcement to protect First Amendment and procedural rights of parties accused by the government. We have demanded that FTC distinguish between speech that is inherently misleading and speech that is only potentially misleading. The Supreme Court has held the latter kind protected by the First Amendment, but FTC does not remove potentially misleading speech from its enforcement regime and, so, imposes huge financial burdens on parties that should suffer no more than a request from the government that a disclaimer be used to remove potential “misleadingness.”

Our clients are also fast at work filing well-supported health claims with FDA under its health claim process, including claims for glucosamine/chondroitin sulfate and osteoarthritis; for lycopenes and cancer risk reduction; for omega-3 fatty acids and coronary heart disease (a revised version of one already approved by FDA). Our clients have several more claims in the works. Dr. Julian M. Whitaker is the plaintiff in a landmark suit against FDA suppression of treatment claims for supplements (the saw palmetto/benign prostatic hyperplasia (BPH) claim). FDA still censors truthful claims about how a supplement affects an existing disease.

Dr. Whitaker is taking that battle to the United States Court of Appeals for the D.C. Circuit. The case has been fully briefed. Oral argument is scheduled for November 10. Those are among the many battles for freedom and constitutional rights our clients are waging.

Passwater: Thank you for chatting with us about these critical developments that will affect the health of our citizens. WF

 

© 2003 Whole Foods Magazine and Richard A. Passwater, Ph.D.

This article is copyrighted and may not be re-produced in any form (including electronic) without the written permission of the copyright owners.