Part Three: The Relationship Between the Level of Regulation under the FDCA and the Health Status of a Product’s Targeted Population

An Introduction to the History of Quack Medicine

In the late nineteenth and early twentieth centuries there was a remarkable growth in the marketing of sham products to treat and cure disease.

At that time, the rate at which quack medicines were being introduced into the market far outpaced the development of the science necessary to establish the efficacy and identify the risks associated with each new product. This scientific lag time created a period when there was an information void that
predatory commercial interests were quick to use to their advantage. As the FDA carried the burden of proof to show that a product did not work or was unsafe in order to remove the product from the market, during this lag time predatory commercial interests were able to profit from scientific uncertainty to the detriment of public health.

During this long period in U.S. history, the curative claims of the predatory sham medicine salesmen were limited only by the gullibility of their targets. In many cases, the degree of gullibility was proportional to the level of desperation of the individual for a cure. The more dire the condition, the more vulnerable an individual was to the ‘flim flam’ of the greedy snake oil salesman. And the more dire the condition, the greater the degree of harm when the sham medicine did not work, causing injury over and above the original illness and/or causing a delay in seeking effective medical treatment. Thus, this lag time between initial marketing of a sham product and the development of the science necessary to resolve uncertainties over the new product’s safety and effectiveness was very costly in terms of human suffering and loss of life. Slaying the Hydra: The History of Quack Medicines

In 1962, after a series of highly publicized public health crises, legislation was passed to close this ‘space between’ created by scientific uncertainty by switching the burden of proof for safety and effectiveness from the FDA and onto product manufacturers.

As more fully discussed in the next entries in this series,

it was not until 1962 that legislation was passed that required manufacturers to obtain premarket approval for new drugs from the FDA by producing “substantial evidence” that the product is both safe and effective for its intended use. The Drug Amendments of 1962 allowed the FDA to make the transition
from its former inefficient and costly police role of enforcing specific statutory prohibitions by removing adulterated and misbranded products from the market, to its current gatekeeper role of preventing those products from entering the market in the first place. Thus, from 1962 until 1994, manufacturers were no longer able to ‘play in the grey’ and take commercial advantage of the scientific uncertainty over the safety and effectiveness of a product to the detriment of public health.

The legislative history of the FDCA makes it clear that Congress also intended that weight loss products fall into the same regulatory category as drugs and devices specifically to deal with predatory profiteering by product manufacturers that targeted a vulnerable population of those who were overweight or obese. In the legislative record, members of Congress expressed their intent to deal with the massive number of “worthless” products being marketed for weight loss at the time. Id.

Thus, prior to the passage of The Dietary Supplement Health Education Act (“DSHEA”) and the Nutritional Labeling Education Act (“NLEA”), the FDCA appears to have required that manufacturers of weight loss supplements obtain premarket approval by establishing the safety and effectiveness of their products before distributing them.

However, the passage of DSHEA in 1994 has confused this situation. To date, it appears that DSHEA is being interpreted to shift the burden of proof back onto the FDA with relation to dietary supplements marketed to both healthy populations and vulnerable, unhealthy populations.

With this over broad interpretation, predatory commercial interests are again being allowed to exploit scientific uncertainty. The door has now been re-opened to the same deceptive advertising that ran rampant in the late nineteenth and early twentieth centuries.

And unfortunately, tens of millions of vulnerable and desperate individuals who are overweight and at grave risk of developing a serious, chronic disease are being lured into this predatory playground. The United States has now come full circle and returned to the era of the snake oil salesman. The very public health problem that the FDCA was originally promulgated to deal with, fraudulent and deceptive products that put the nation’s health at risk, has reared its ugly head once again. Id.

The next blog post in this series delves into more details regarding the history of the quack medicines to give additional perspective to the relationship between the FDCA, the FDA and predatory commercial interests.

Post Two of a Series: The Relationship Between the Level of Regulation under the FDCA and the Health Status of a Product’s Targeted Population

The first post of this series began by asking whether functional foods should be regulated as drugs if they claim to treat abnormal health conditions. For example, was it appropriate for the FDA to characterize Cheerios as a drug as a result of its advertising claim that “you can Lower Your Cholesterol 4% in 6 weeks?” An abnormally high cholesterol level is a serious risk factor for disease and those with high cholesterol levels are in an abnormal state of health. By virtue of its claims to help this group of unhealthy consumers with their struggle to return to a normal state of health, should the manufacturer of Cheerios be required to undergo the FDA's premarket approval process to show that eating Cheerios is effective in lowering cholesterol as claimed?

The answer to this question may become more apparent by looking at another category of products that claim to help unhealthy people return to a normal health status – weight loss products.

The Obesity Crisis and Weight Loss Products

The United States’ obesity crisis is gaining momentum. In only fifteen years, eighty percent of Americans will be either overweight or obese. Being overweight or obese places an individual at a significant risk for developing hypertension, Type II diabetes, heart disease, stroke and cancer.

Conservative estimates predict that the health care costs associated with this epidemic will reach $956.9 billion in the 2020s. One of every six dollars spent on health care will be associated with the conditions of being overweight and obese. Significantly, for the first time in over a century, children and young adults will have a shorter life expectancy than their parents.

"This obesity epidemic has been matched by a rapid growth in the weight loss supplement industry. Overweight consumers desperate to lose weight are being lured by ‘magic bullet’ claims into purchasing ‘quick-fix’ weight loss supplements in order to lose weight and decrease their risk for disease. As the result of prodigious marketing campaigns, many adults and adolescents ... are turning to weight loss supplements as an alternative to diet modification and exercise.

Advertisements for the ‘quick-fix’ product that works to melt off pounds without diet or exercise, some even while you sleep, are everywhere. Enforma Natural Products, Inc. ran an infomercial marketing its product Exercise in A Bottle claiming it “helps your body burn more calories while you’re just standing or sitting around doing nothing – even while you are sleeping” and “[y]ou can enjoy all those delicious foods like fried chicken, pizza, cheeseburgers, even butter and sour cream, and stop worrying about the weight.” The manufacturer of a similar product called Maxiline advertised heavily by taking out full-page newspaper advertisements stating “[s]leep … and lose weight in just a few nights … you eat whatever you want.” The advertisement stated that the product worked because “the body’s fat cannot defend itself from attack while asleep.”

Commercials on television and radio, lengthy infomercials, magazine advertisements, mass mailings of brochures and Amway and “Avon-Calling” type visits from friends and neighbors hawking miracle potions for magical weight loss flood the American consciousness. In 2000, the sale of weight loss supplements in the United States reached $4.7 billion, with a projected increase of ten to twenty percent annually.

In the book Through the Looking Glass, Alice said, “[o]ne can’t believe impossible things.” The White Queen answered: “I daresay you haven’t had much practice . . . . When I was your age . . . I’ve believed as many as six impossible things before breakfast.”

Like Alice, for many, the impossible weight loss claims made by the current breed of snake oil salesmen defy credibility. However, viewed in context, these beliefs are more understandable. Many of these consumers, and, shockingly, their physicians, incorrectly believe that the FDA requires premarket testing to establish that these weight loss supplements are both safe and effective. In fact, the FDA does not require that these products undergo clinical testing for safety or efficacy prior to being placed on the market. This vast market exists in spite of the fact that there is little to no evidence that most of these products actually work. To the contrary, there is growing evidence that many are ineffective and unsafe.

In 2002, the FTC issued a report that fifty-five percent of the claims made within advertisements of over-the-counter weight loss products were either false or misleading. According to the FTC, more consumers are defrauded by weight loss products than any other product it has examined." Slaying the Hydra: The History of Quack Medicines

Why isn’t the FDA using its premarket approval authority to keep these sham products from entering the market in the first place? Not surprisingly, the weight loss supplement industry is marketing its products as dietary supplements and is claiming the safe haven protections from FDA regulation offered under the Dietary Supplement Health Education Act (“DSHEA”) and the National Labeling Education Act of 1990 (“NLEA”). What is surprising is that the FDA appears to agree. Are the weight loss supplement industry and the FDA correct?

The next several posts in this series will examine the history of the relationship between the FDCA, the FDA and predatory commercial interests and will ask whether there are lessons from the past that can assist in the analysis of current regulatory issues involving food, functional food and dietary supplements. If so, do these lessons also offer insights into the regulation of nanotechnology used in consumer products for direct and indirect human consumption — including food (directly and through the food production process), food supplements, cosmetics and sunscreens?

Reaction to NYTimes Article on Well Contamination

I read yesterday's New York Times article, Health Ills Abound as Farms Runoff Fouls Wells with great sadness. The article focuses on the impact that the over-application of manure from large dairy farms can have on groundwater resources and the contamination of wells in Wisconsin. It is the tragic story of the risks associated with intense winter manure application and the effect of an early thaw.

"In Morrison, more than 100 wells were polluted by agricultural runoff within a few months, according to local officials. As parasites and bacteria seeped into drinking water, residents suffered from chronic diarrhea, stomach illnesses and severe ear infections.

“Sometimes it smells like a barn coming out of the faucet,” said Lisa Barnard, who lives a few towns over, and just 15 miles from the city of Green Bay.

Tests of her water showed it contained E. coli, coliform bacteria and other contaminants found in manure. Last year, her 5-year-old son developed ear infections that eventually required an operation. Her doctor told her they were most likely caused by bathing in polluted water, she said."

I am saddened because the article presents a chilling criticism of an industry that I have spent most of my professional life supporting; I am saddened because I grew up on a dairy farm in a rural area not unlike the Wisconsin community described in the article. I know how many of us rely on wells for our water source. But, I am probably most distressed by what I anticipate will be the reaction of many in the farm community to this story. There will be talk of the east-coast urban media, people that just don't "understand agriculture," and denial.

My response - and I do understand agriculture - is that it is time for the agricultural industry as a whole and farmers as individuals to stop putting up a wall around themselves and arguing that all of the criticism is unjust. The wells that are contaminated in Wisconsin are the wells of farmers, rural residents, and rural community schools - the fabric of the world that surrounds our farms. This is not an us-against-them issue. It is time for the industry to stop viewing environmental problems as a public relations issue and step up to the plate. A good dose of honest, self-reflection is good for everyone.

The same might be said for consumers. We clamor for low cost food and complain when prices go up. We reward producers and manufacturers who cut costs by searching for the cheapest products available. For some this might be a necessity; for most of us, it represents a false economy. Do we really want a food system that is only financially viable because we do not keep track of the environmental problems it creates?

Government policies, the structure of our milk marketing system, consumer desire for cheap food, and our failure to add the cost of environmental externalities into our economic analysis have put many small Wisconsin dairies out of business. All of these factors have encouraged farmers like those interviewed in the story to expand their operations, creating the megafarms that produce more waste than many cities.

"One of those farmers, Dan Natzke, owns Wayside Dairy, one of the largest farms around here. Just a few decades ago, it had just 60 cows. Today, its 1,400 animals live in enormous barns . . . In June, Mr. Natzke explained to visiting kindergarteners that his cows produced 1.5 million gallons of manure a month."

Only when we admit that there are serious problems can sustainable solutions be achieved. Those solutions should be in the long term best interests of farmers and consumers. Unless farmers admit to the problems their operations are causing, they will not be included in the formation of those solutions.

Farmers have long argued that they were different from corporations - that their concern was not based solely on the bottom line, that they cared about the future of their land and their community. I say its time for agriculture to prove it.

Post 1 in Series: The Relationship Between the Level of Government Regulation under the FDCA and the Health Status of a Product’s Targeted Population

Cheerios -- a Drug?

This past May, the FDA issued a warning letter to General Mills stating that the claim on Cheerios cereal that “you can Lower Your Cholesterol 4% in 6 weeks” turned the Cheerios from a food into an illegally marketed drug. When bloggers heard the news, posts ran from scolding the FDA to “grow-up,” to those which lauded the FDA’s action.

Who is correct? Is targeting a cereal one of those cases where, as one blogger suggested, the FDA has its priorities wrong? A look at one recent food trend may help answer this question.

By making its cholesterol lowering claims, Cheerios is entering the growing market for functional foods. In 2008, functional foods -- which are defined as foods that claim to have health benefits over and above the delivery of nutrients -– were a $30.7 billion dollar market. This market is predicted to grow by 40% over the next several years.

Examples include: probiotics in salsa and ketchup; omega-3 fatty acids in orange juice, eggs and peanut butter; pasta enriched with calcium; heart healthy ginger ale infused with green tea; ‘energy’ drinks with amino acids for joint health. The list goes on and on. One never knows what might pop up in a favorite food.

And now a new category of functional foods is cropping up which industry is calling cosmeceuticals -– foods that are being marketed to enhance appearance. (A bit confusing because that term is commonly used to describe drugs that are being marketed as cosmetics. Perhaps cosmefood would be better?). One example of a cosmeceutical for skin beauty is a product on the market that consists of marshmallows infused with allegedly skin-boosting collagen.

Fortified foods are not new. Iodine has been added to salt since 1924 to reduce the incidence of goiter. Grains have been fortified with niacin, thiamin, riboflavin and iron since 1943, a public health move that almost eliminated brain/skin degenerating pellagra within a decade. However, present day functional foods are flooding onto the market before the science exists on the effectiveness of many of their associated health claims.

Where should the FDA draw the line on regulation? Should the level of product regulation be linked with the health status of the product’s targeted population? While not stated explicitly, it appears that this is the strategy that the FDCA has followed since its inception. See Van Tassel, K., Slaying the Hydra: The History of Quack Medicine, The Obesity Epidemic and the FDA's Battle to Regulate Dietary Supplements, 6 Indiana Health L. J. 203-251 (2009).

Traditionally, the greatest amount of regulatory protection under the Food Drug & Cosmetic Act (“FDCA”) has been applied when products are targeted at vulnerable, unhealthy populations and claim to aid in an individual’s struggle to return to normal health. Examples of products that fall into this category by making health remedy or recovery claims include drugs and devices. For these products, the modern FDCA establishes a premarket enforcement process that places the majority of the cost and burden on the product manufacturer to establish safety and efficacy through the clinical trial process prior to distribution to the public. Without premarket approval from the FDA, these products will be deemed both adulterated and misbranded as a matter of law.

Conversely, the FDCA requires less regulatory protection when products are targeted to healthy populations to maintain or improve a normal state of health. Examples of products that fall into this category are traditional foods, and (until recently) a very limited number of functional foods and (once again, until recently) a similarly narrow category of dietary supplements. For these products, the FDA carries the burden of removing an unsafe or ineffective product by proving that it is adulterated or misbranded.

Currently, far too many functional foods and dietary supplements are being marketed to the unhealthy and vulnerable by making health recovery or remedy claims without demonstrating through premarket approval that their products are both safe and effective. It appears that Cheerios is just one product of many that are making these claims.

An abnormally high cholesterol level is a serious risk factor for disease and those with high cholesterol levels are in an abnormal state of health. Cheerios is claiming to help this group of unhealthy consumers with their struggle to return to a normal state of health. As one commentator remarked, it is possible “that some people with high cholesterol will see eating breakfast as a clinical treatment, perhaps even offsetting a more pressing need to cut back on French fries.” Consequently, by sending its warning letter to Cheerios, it appears that the FDA is heading down the right path.

The merits of the FDA’s position on Cheerios specifically, and functional foods more generally, may become more apparent by looking at another category of products that claim to help unhealthy people return to a normal health status -– weight loss products.

The next in this series of blog posts will provide a general introduction of the current problems with the claims being made by weight loss products, particularly in the context of the obesity crisis. The focus on the example of weight loss products will provide a structure for the following posts which will take a look back through the history of the relationship between the FDCA, the FDA and predatory commercial interests. Through this exercise, regulatory patterns will be identified that appear to link the level of product regulation with the health status of the product’s targeted population.

The goal of this series is to take lessons from the past and apply them to assist in the analysis of current regulatory issues involving food, functional food and dietary supplements. This first series will provide the ground work for the second series which will delve into the use of nanaotechnology in consumer products for direct and indirect human consumption -- including food (directly and through the food production process), food supplements, cosmetics and sunscreens.

— KVT

Economics Driving Dairy Herd Health Measure

A few ramblings since I haven't blogged in a while. This story came through my inbox this morning. Apparently high somatic cell counts in milk are not a food safety issue. But placing this sort of regulation on the industry would have the anticipated effect of removing supply from the market and driving up prices, while improving herd health. I wonder if consumers are as excited about this change as some dairy producers.

In the crop production sector, I often ask my students if the Conservation Reserve Program was politically possible because of the anticipated (though perhaps unrealized) effect it could have on commodity prices. Again, I wonder if consumers were on board with this.

Dean Chen's American Ideology comes to mind. It is a testament to what I tend to think of as consumerism and its role in technological advance as it relates to feeding more people at lower costs--a call to arms of sorts. But I wonder which way consumerism cuts. What they want is perhaps different from what they should want. Or, maybe, consumerism works to bring food safety and affordability concerns to producers, but maybe it doesn't bring herd health and environmental concerns to bear as well. Of course, if there is a correlation between such concerns, then consumerism does many things well. But the elephant in the room is always, I suspect, what they'll pay for and what they won't.

There is Much to Learn from the Man Who Fed the World

Norman Borlaug, who was reluctantly known as the "father of the broad agricultural movement called the Green Revolution," passed away on Saturday night at the age of 95. As the New York Times reports, "[H]is work had a far-reaching impact on the lives of millions of people in developing countries. His breeding of high-yielding crop varieties helped to avert mass famines that were widely predicted in the 1960s, altering the course of history."

His work is not without controversy. Many critics have claimed that his processes created large corporate farming (at the expense of smaller farmers) and used far too many chemicals. However, there can be little doubt about his impact on the world. The Times reports one estimate that roughly 50% of the world’s population consumes grain that can be traced to the high-yield varieties created by Dr. Borlaug and his colleagues.

Perhaps most important, and a continuing lesson to all of us, is that despite his ardent belief in his work, over time he recognized some of the environmental concerns his methods raise, and ultimately advocated a more tempered use of fertilizers and pesticides. In all our work, whether in the law or the sciences, we need to keep in mind that even when the cause is just, and motivation proper, there may be a better way to achieve our goals. In light of the tenor of recent debates on health care and energy legislation, this is clearly a lesson worth learning.

Defining Natural Meat - A Chance to Comment

On Friday, September 11, USDA's Food Safety and Inspection Service (FSIS) announced an Advance Notice of Proposed Rulemaking (ANPR) to solicit public comment on the use of the term "natural" on meat and poultry products labeling.

This has been a contentious issue. Current FSIS policy states that the term "natural" may be used "provided that the product does not contain any artificial flavor or flavoring, coloring ingredients, chemical preservative, or any other artificial or synthetic ingredient and that the product is not more than minimally processed." However, the issue of whether or not this would allow for the use of a "natural" label when sodium lactate made from corn was added to the meat has been at the center of the controversy.

The FSIS began to consider its definition of natural in response to an industry petition filled in October 2006. In December 2006, FSIS held a public meeting and requested comments on "natural" claims, receiving a high number of comments. No action was taken, with labeling approval decisions made on a case-by-case basis.

Comments can be submitted by email through the Federal eRulemaking Portal at www.regulations.gov. Posted Instructions: "Go to www.regulations.gov and in the "Search for Open Regulations" box, select "Food Safety and Inspection Service" from the agency drop-down menu and then click on "Submit." In the Docket ID column, select FDMS Docket Number FSIS-2006-0040A to submit or view public comments and to view supporting and related materials available electronically."

Comments can also be mailed to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, 5601 Sunnyside Ave, Room 2-2127, Beltsville, Md. 20705.

Comments must be received by November 13, 2009.

Note that the Agricultural Marketing Service (AMS) issued rules on a voluntary certification for a "naturally raised" marketing claim standard at 74 Fed. Reg. 3541 (Jan. 21, 2009). The AMS naturally raised standard has been criticized by some because it does not incorporate any standards for production issues such as requiring pasturing or access to the outdoors. FDA has not defined the term "natural" although has implied that ingredients that were subject to significant processing may still be considered to be "natural."

UPDATE: The ANPR was published on Monday in the Federal Register at 74 Fed. Reg. 46,951 (Sept. 14, 2009).

Bill Marler Launches Online Newspaper, Food Safety News

Bill Marler, food safety expert and food borne illness litigator just announced the creation of a new online food safety newspaper that will launch on Monday, September 14. Food Safety News To Go Live. This is just another step in the fascinating public advocacy/private practice mix that is Marler's career.

Bill Marler has been a major force in food safety policy since the 1990's. He and his partners at Marler Clark have represented thousands of individuals in claims against food companies whose contaminated products have caused serious injury and death. They have secured more than $300 million for their client victims.

But, Marler's work extends beyond litigation. His advocacy for greater food safety has led to invitations to address local, national, and international gatherings, including recent testimony to US Congress Committee on Energy and Commerce. The non-profit corporation that he founded, Outbreak provides advice and consultation to the industry in an effort to prevent future illness. Among his many honors is the 2008 Public Justice Award, given to him by the Washington State Trial Lawyers Association.

Last week, he visited the LL.M. Program in Agricultural & Food Law to teach the Food Law & Policy class and the Emerging Issues in Food Law class. His visit is described in Highlights from the Bill Marler Visit on the LL.M. Program's blog.

Marler is almost constantly in and on the media. For example, he was most recently quoted in the Washington Post article, This Woman Might Die From Eating Cookie Dough, Severe Case Gives Context to Issue of Food Safety. But, his media connections include an impressive array of social networking venues. His very active blog, Marlerblog is regularly visited by both food safety advocates and by defendants in his cases. And, he has an active presence on Twitter. With a nationwide practice, he communicates with clients and colleagues all over the country with almost continual email contact.

Beginning Monday, Food Safety News will be another step in communication, and it should serve to provide additional encouragement for public recognition, enhanced efforts at industry prevention, and a push for constructive government regulation of the problem of food safety.

The latest issue of The Agricultural Law Brief, published by the Agricultural Law Resource and Reference Center at Penn State Law was just posted. This issue contains information on the following topics:

• Ohio ballot issue proposing creation of Livestock Care Standards Board;
• Commonwealth Court ruling on East Brunswick Township biosolids ordinance;
• Litigation regarding natural gas drilling in the Allegheny National Forest;
• "Anytime, Anywhere" rule for milk in schools; and
• Court of Common Pleas ruling that a poultry farm did not constitute a nuisance.

New Analysis of H1N1 and Swine: Separating Fact From Fear

Last spring when “swine flu,” now referred to as the H1N1 virus outbreak first occurred, internet journalists suggested that one or more Mexican swine CAFO’s (Concentrated Animal Feeding Operations) may have been the source. See Tom Philpott’s posts on Grist and David Kirby’s on Huffington Post. Smithfield, the owner of the CAFOs strongly denied the allegations, citing their own internal testing. Due to the rapid replication of viral strains, there is no way to find out where the outbreak actually originated.

Questions swirled about why it was called “swine flu,” pork sales plummeted, and the pork industry went on a massive public relations campaign. There was never any link between eating pork and getting the flu - H1N1 is a respiratory virus. The connection to pigs, however, goes all the way back to the flu pandemic of 1918. It is not known whether humans first infected pigs or pigs infected humans, but as pigs can survive infection, they have been "a reservoir for the virus ever since."

A new article, Swine CAFOs and Novel H1N1 Flu: Separating Facts from Fears, by Charles W. Schmidt, just published in Environmental Health Perspectives Volume 117, Number 9, September 2009 addresses these issues and provides a thoughtful, point by point discussion.

While some rumors are dispelled, other fears are reaffirmed. The article notes that public health scientists continue to express concerns about whether enough effort is being made to study the role of CAFOs and the animal-to-human transmission that occurs through the farm workers in such a concentrated environment. The article discusses these concerns, including the lack of research and testing about human viruses in swine CAFOs, despite our knowledge of the easy transmission between the two species. Research from Iowa in 2007 “strongly suggests that CAFO workers and veterinarians can infect other people with H1N1 viruses,” showing that “CAFO workers were 50 times more likely to have elevated H1N1 antibodies than nonexposed controls.” Their spouses were “25 times more likely to harbor these antibodies.” Nevertheless, we do not have required reporting or a coordinated, effective government effort in this area. Testing now is almost exclusively in the hands of those in the pork industry, with great disincentives for reporting human health problems; research is largely funded by the same industry; OSHA workplace standards exempt most CAFO workers; and workers are widely dispersed, with no regional or national network.

I recommend the article to anyone interested in either public health or the pork industry.