Pro-consumer? An Exchange on Co-ops and the FDA
Pickford is "Disappointed" and Center for Science in the Public Interest says "Dangerous"
November 2, 1992
Editor, Cooperative Grocer:
I was disappointed by your editorial in the current issue of Cooperative Grocer which endorses efforts by Orrin Hatch and other right wing elements to weaken the Nutrition Labeling and Education Act of 1990.
My views regarding this industry crusade are summarized in the enclosed materials, which were mailed last month to our member store managers and board presidents. I urge you to balance your editorial by printing the views of Center for Science in the Public Interest, the Consumer Federation of America, the National Consumers League, and other key organizations in the consumer movement regarding NLEA and the Health Freedom Act in your January-February issue.
I believe you have missed the mark on this, Dave. What is good for the natural supplements industry is not necessarily good for consumers. It is beyond me why people who would never unquestioningly accept self-serving claims from pharmaceutical companies, food processors, or the Chamber of Commerce believe they can rely on... natural products industry flacks for an objective analysis of the NLEA or new FDA authorities. These people have a personal financial interest in defeating public oversight or regulation of their businesses.
Consumer co-ops have a responsibility to put their members' interests ahead of their industry allegiances, and we who are leaders in the co-ops have a responsibility to say so. Your position on the NLEA and the Hatch initiatives are at odds with the rest of the consumer movement. That fact, if nothing more, deserves to be prominently acknowledged in a magazine which claims to speak for consumer owned co-ops.
Robert J. Pickford
Chief Operating Officer, Federation of Ohio River Cooperatives
(Below, additional statements from Pickford's October memo to FORC member retails concerning the "Health Freedom Act of 1992. ")
Unfortunately, some co-ops appear to have taken a position on the "Health Freedom Act" based primarily on information provided at trade show workshops and in trade publications . . . Trade publications are produced by the industry they represent and exist solely to promote its interests, products, and profits. They cannot be relied on as news magazines because they do not observe the rules of objective journalism. To the contrary, trade shows and journals are elaborate advertisements and their content should be evaluated as such.
This issue offers consumer food cooperatives an opportunity to distinguish themselves in the marketplace from their profit oriented competitors. The struggle to protect people from dangerous products, fraudulent advertising, false labeling, and bogus product claims has been central to the U.S. consumer food co-op movement since its beginning more than 75 years ago. As businesses organized exclusively to serve consumer needs and interests, our cooperatives should lead the effort to assure that the products we sell tell the truth, do what they claim to do, are what they are represented to be, and won't harm our memberswho use them. We should, at minimum, hold the natural products industry to the same standards ofhonesty and effectiveness already required of food and drug companies.
Center for Science in the Public Interest: "Dangerous"
(from an October CSPI statement)
The FDA needs this legislation because it does not have the power to stop the sale of or recall products that pose safety hazards, to inspect manufacturing records, or to impose monetary penalties against firms that repeatedly violate the law.
...The NLEA will not restrict the marketing of products that do not make health claims, nor will it require consumers to obtain a prescription before purchasing such products. Unrelated to the NLEA, however, the FDA may in the future use other statutory authority to ensure the safety of dietary supplements.
... The Health Freedom Act of 1992 [which did not pass] repeals portions of the NLEA by permitting companies to make health claims for dietary supplements that are supported only by a "reasonable basis" that could consist solely of unpublished "scientific evidence." Permitting such tenuous claims creates a dangerous conflict of interest that opens the doors to abuse.
Moreover, this legislation creates a situation in which dietary supplements will be able to make health claims not permitted for traditional foods that contain the same amount of the nutrient. This loophole must not be permitted. . . . In addition, these bills enable those engaging in misleading labeling and advertising to challenge even FDA warning letters in court, thus creating an incentive for companies to delay enforcement proceedings that endanger the sale of their products....
Dave Gutknecht, in response: Whose agenda?
To first bring readers up to date: A one-year moratorium on the implementation of nutrition labeling regulations pertaining to dietary supplements became law on October 30. Sen. Hatch prevented approval of another FDA-related bill until it included his Dietary Supplement Act of 1992, which delays implementation of regulations proposed by the FDA pursuant to the 1990 Nutrition Labeling and Education Act (NLEA).
New proposed regulation are to be published by June 15, and final regulations by December 31, 1993. In response to criticisms concerning FDA actions against supplements and alternative health care, the Dietary Supplement Act also calls for two studies by congressional agencies: one of the decision-making and enforcement priorities at the FDA as it relates to dietary supplements; the other examining supplement regulation in industrialized countries and its public health effects. But neither study, it appears, will have any significant impact on the regulations to be issued in 1993.
Meanwhile, on December 2 the FDA and Health and Human Services finally announced the new labels required under the NLEA for packaged foods. Almost every food product -- but not in restaurants, and not produce, fish, poultry, and fresh meat, which are exempted -- will now bear information on total fat, saturated fat, cholesterol, sodium, carbohydrates, protein, calories, vitamins and more, in a standard format. Use of certain terms will be standardized. But for most nutrients, Recommended Daily Allowances (RDAs) will be replaced by Reference Daily Intakes (RDIs) that are 20 to 80 percent lower.
Cooperatives and other consumer groups can applaud improved presentation of nutrition information. Co-ops have for decades been in the forefront of full disclosure practices and continue to operate on the principle that consumer knowledge supports their way of doing business.
Actually, contrary to some, I believe that much of the natural products industry, the industry in which most food co-ops compete, does support the intent of the NLEA -- but not the supplement-related provisions proposed by the FDA. The natural products industry thrives on customers who are taking greater interest in their diet and their health, and improved information on food labels gives further fuel to these consumer trends.
I believe you have missed the mark on this, Bob. Holding the natural products industry to "the same standards of honesty and effectiveness already required of food and drug companies" makes the disagreeable assumption that there are worthy standards being upheld by the FDA and the Department of Agriculture. With the latter agencies' blessing, the food and drug giants are the ones polluting the food supply and general environment with unhealthy food and experimental, often unsafe additives and processing methods. It's not from excessive echinacea or Vitamin D supplements that citizens are being harmed -- such stories rarely pan out -- but from dietary excesses and deficiencies and dangerous additives. But these latter are not an FDA priority.
The RDIs are one way in which the NLEA is a step backwards. In lowering dietary standards, they further undermine public policy support for good health and the needs of high risk groups.
A label accurately listing the pills' dosage is fine; but don't try to tell someone that a higher level of nutritient X will be better for their health. The FDA knows better. Consumers need to be protected from such statements.
The FDA and its allies have so succeeded in this campaign that even an excellent watchdog organization such as Center for Science in the Public Interest earnestly urges us not to worry because "the NLEA will not restrict the marketing of products that do not make health claims." Why shouldn't reasonable claims be allowed -- is that so dangerous? What happens to self help health care, to freedom of inquiry? Not only labeling is at issue here. Other legislation and FDA actions focus on products and on additional media; historically, even books have been suppressed by the FDA.
Can one really believe that agents in the Health and Human Services bureaucracy, witting and unwitting as to whose interests their policies serve, have arrived at the final word in health care? Have the drug and food companies, American Medical Association, and other institutional forces learned what there is to know to maintain the health of our population? They too "have a personal financial interest in defeating public oversight or regulation": better for consumers to remain dependent on them than to use diet, herbs, and supplements to improve their health and reduce that dependence.
The FDA's outrageous police actions (even the moderate columnist James Kilpatrick called them that) are too numerous to relate here, and have been going on for years. The Congressional mandate to report on FDA priorities is a concession to criticism of such actions. The NLEA was intended to help improve our population's declining health by providing more nutrition information as a means of disease prevention. The reality is that advocates of improved nutrition have had to fight the FDA even to allow mention of commonly accepted diet/health links such as fiber and cancer.
Historically, despite the dreams of liberals, regulators tend to end up in bed with the regulated. The FDA, in the name of consumer protection of course, is keeping attention focused away from the corporate and public policy sources of our health malaise. Dr. Feelgood's dangerous pills are like Dr. Strangelove's cold war threats to our precious bodily fluids, mostly serving as a red herring useful to the medical-industrial complex that profits by our illnesses and dependence.
Editor's Note: the following letters were originally published in CG #45, but since they are all part of the same exchange as the letters above, they are included here.
Why Co-ops Should Support the Health Freedom Act
In response to the letter from Bob Pickford and the information from his memo (see exchange in the previous edition):
"Consumer co-ops have a responsibility to put their members' interests ahead of their industry allegiances" -- Bob, I couldn't agree with you more. And I can't think of anything more important to me as a consumer than having the right to choose the products I want to use and having the information I need available to allow me to make those choices. This is especially important when it concerns the foods I choose to consume and the products I want to use to keep me healthy.
Congress intended the Nutritional Labeling and Education Act (NLEA) to "help American consumers become more informed on the value ofimproved nutrition to their health care needs," according to the Congressional Record. This was to be done by providing for full nutrient disclosure and other diet and health information on the label and by developing a mechanism for making health claims. Contrary to Mr. Pickford's assertion, the nutritional foods industry was a proponent of the NLEA legislation. What the industry and consumers objected to were the way the section of the regulations concerning dietary supplements was written by the Food and Drug Administration (FDA).
These regulations, as written, could impact the availability of many vitamins and herbs. For instance, when a food is a concentrate, such as in a higher potency vitamin or an herb extract, that food would be regulated as a drug. Meeting the standards for proving safety and efficacy as drugs costs $231 million, according to the Chemical Marketing Reporter. Since 1962, when the drug efficacy provisions were passed, not a single plant medicine has been approved. This is because herbs and supplements are non-patentable products. Drug companies recoup their research and development expenses through charging high prices on drugs during the life of the patent. This means that vitamins with a higher potency than normally found in food, such as 500 mg Vitamin C tablets or concentrated herbs such as echinacea extract, would either become unavailable or be high priced drugs.
Food, Drug -- or Folklore?
I do not believe the Health Freedom Act is the complete answer to the regulation of herbs and vitamins, but I do believe it is an important step to take now. If we don't act to save our supplements, there won't be any next step to take. Once we pass the Health Freedom Act, what next? What is the best way to regulate preventive medicines? Should they be regulated as foods or as drugs? I think the answer is neither, but this is the only option in our current regulatory framework.
Another alternative was recommended by an expert advisory panel to the Canadian Health Protection Branch (the counterpart to our FDA) about 5 years ago. Recognizing that folk medicines always have been and always would be used, and recognizing the futility of trying to regulate them out of existence, the panel recommended a separate category of folklore medicines be established. This eliminates the problems with regulating them as drugs by allowing better, safer, and more useful labeling. Contraindications or cautions, such as avoiding during pregnancy or not combining their use with certain medications, could be stated on the label. Directions for use and dosage information could also be given. it also would elminate the problems with regulating these products as drugs; there would be no prohibitively expensive efficacy testing required. In fact, a disclaimer would be included stating the herb was not proven effective according to scientific method but its use was based on cultural, historical or folk infomation. This category would also allow for greater controls on the production and therefore the safety of these products. The Health Protection Branch chose not to follow their own panel's recommendations, but it is an option we can work for. A folkloric medicines category would accommodate safety and quality control of preventive medicines while offering responsible labeling. KKL
Another problem with NLEA is the narrow view the FDA took regarding allowable health claims. Opinions of qualified experts differ, and it sometimes takes many years to reach scientific consensus. The FDA took the narrowest view they could by listing only 10 health claims which could be made for foods. Claims where differences of opinion occurred were not even considered and even some which have scientific agreement were overlooked. For example, they did not include folic acid supplementation as a preventative of neural tube birth defects, which even the government itselfrecognizes as valid through the Public Health Service.
And the FDS did away with the RDAs or recommended daily allowances, and replaced them with with RDIs or referenced daily intakes, which in most cases are significantly lower than RDAs. This is another area of controversy; many qualified experts believe a number of people are not getting enough nutrients in their diets, and using the new RDIs will only exacerbate the problem.
I think these examples are consumer issues, not just the issues of the companies selling nutritional products. It is a mistake to decide what is the right side of an issue by looking only at the politics of those for or against it. It is also a mistake to assume that trying to make a profit automatically means you must be bad or be on the wrong side of an issue. The natural and nutritional foods industry and the preventive health care movement in this country are strongly consumer oriented. The FDA, through enforcement acts, policy, and attacks on natural foods and health care options has made it clear they do not intend to allow consumers access to these products if they can help it. While liberals traditionally favor government regulation in order to protect consumers against big business, in this case many of those same liberals want protection from the FDA in order to have access to a wide range of health care options. This has created an opportunity for conservatives such as Senator Hatch to champion the Health Freedom Act of 1992.
If I want to take responsibility for my own health care rather than relying on the government to dictate what is good for me, does that make me a conservative liberal or a liberal conservative? I think it's time to quit caring about labels and start looking at issues. We need to forge a coalition of people regardless of their profit motives or their politics to get legislation and regulations which will let us have good, safe products, with an abundance of information allowing each of us to decide how best to take care of our health.
The Health Freedom Act will be reintroduced into Congress this year, probably by a liberal Democrat in the House (Rep. Richardson) and a conservative Republican in the Senate (Sen. Hatch). In order to pass, it needs our support: industry support, consumer support, and co-op support. If we are divided, and they will try to divide us, we will fail. The losers will be all of us, including Mr. Pickford, the herb and supplement companies, and everyone like me who wants the freedom to choose to use herbs and vitamins in their health care program.
Kathy Krezek Larson
Herbalist, Frontier Cooperative Herbs