The Law And Vitamin Freedom In The United States

This presentation was given by Kevin Grimes to the Hague Tribunal, 15th June 2003

To be perfectly honest, I think that listening to a lawyer talk about anything is about as exciting as watching grass grow and as pleasant as getting a cavity in your tooth filled.

It is my privilege to have the opportunity to talk with you about the state of the law and vitamin freedom in the United States.

The good news is that vitamin freedom has increased dramatically in the U.S. during the last 20 years and that the current state of the law regarding nutritional or “dietary” supplements is better than it has ever been. While the pharmaceutical industry still retains a vast stronghold in the U.S., it is losing ground.

The bad news is that this is not a trend that is mirrored elsewhere in the world, and there are, even in the U.S., serious threats to vitamin freedom.

With your indulgence, I would like to share with you an overview of the history of dietary supplement freedom in the U.S. My problem is that I have got several hours of information that I have to compress into 15 minutes. So if my remarks are not particularly coherent, I hope you will forgive me. In the time I have, I will briefly discuss.

Regulatory Agencies

Two federal governmental or regulatory bodies have jurisdiction over dietary supplements – the FDA and FTC.

Definition – A “dietary supplement” is

• A “product intended to supplement the diet” that contains one or more of certain dietary ingredients, including a vitamin, a mineral, an herb or other botanical, or an amino acid,”
• “ Is not represented for use as a conventional food or as a sole item of a meal or the diet,” and
• “ is labeled as a dietary supplement,”

FDA

Products regulated — FDA is the federal agency responsible for foods, human and veterinary drugs, biological products, medical devices, cosmetics and electronic products that emit radiation. The FDA has jurisdiction over product approvals (for drugs and medical devices), product safety, manufacturing, and labeling, which includes product claims.

The bottom line is that the FDA tells the world that it is all about protecting consumers and promoting public health. With respect to dietary supplements, this has historically meant the suppression of the truth. One of the most frustrating things that I have to tell clients is, “Just because it is true, doesn’t mean you can say it.” Thus, the truth can sometimes be hard to find.

FTC

Mission — To ensure the smooth operation of our free market system, the FTC enforces federal consumer protection laws that prevent fraud, deception and unfair business practices. The FTC’s primary mission is to protect consumers.

The FTC is the Nation’s enforcer of federal truth-in-advertising laws. Among other things, its law enforcement activities focus on claims for foods, drugs, dietary supplements, and other products promising health benefits.

State regulation

The History of Dietary Supplement Law in the U.S.

Two very significant laws enacted in the last 15 years. In order to understand the current state of the law regarding dietary supplements in the U.S., you must have the backdrop of

(1) The Nutrition Labeling and Education Act or NLEA; and
(2) The Dietary Supplement Health and Education Act, or DSHEA.

The Dietary Supplement Health and Education Act

Introduction

DSHEA is the biggest legal victory for the consumer and the nutrition industry in the history of the U.S.

Congressional Intent – This is fantastic! You have got to hear this. In Section 2 of DSHEA, Congress wrote

Congress finds that –

(1) Improving the health status of United States citizens ranks at the top of the national priorities of the Federal Government;
(2) The importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in scientific studies;
(3) (A) there is a link between the ingestion of certain nutrients or dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis; and
(B) clinical research has shown that several chronic diseases can be prevented simply with a healthful diet, such as a diet that is low in fat, saturated fat, cholesterol, and sodium, with a high proportion of plant-based foods;
(4) Healthful diets may mitigate the need for expensive medical procedures, such as coronary bypass surgery or angioplasty;
(5) Preventive health measures, including education, good nutrition, and appropriate use of safe nutritional supplements will limit the incidence of chronic diseases, and reduce long-term health care expenditures;
(6) (A) promotion of good health and healthy lifestyles improves and extends lives while reducing health care expenditures; and
(B) reduction in health care expenditures is of paramount importance to the future of the country and the economic well-being of the country;
(7) There is a growing need for emphasis on the dissemination of information linking nutrition and long-term good health;
(8) consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements;
(9) National surveys have revealed that almost 50 percent of 260,000,000 Americans regularly consume dietary supplements of vitamins, minerals, or herbs as a means of improving their nutrition;
(10) Studies indicate that consumers are placing increased reliance on the use of non-traditional health care providers to avoid the excessive costs of traditional medical services and to obtain more holistic consideration of their needs;
(11) The United States will spend over $1,000,000,000,000 on health care in 1994, which is about 12 percent of the Gross National Product of the United States, and this amount and percentage will continue to increase unless significant efforts are undertaken to reverse the increase;
(12) Although the Federal Government should take swift action against products that are unsafe or adulterated, the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers;
(13) Dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare; and
(14) Legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness; and
(15) A rational Federal framework must be established to supersede the current ad hoc, patchwork regulatory policy on dietary supplements.

These truths are not merely true for Americans! They are true for every citizen of this planet!

Burden of Proof of Safety – DSHEA did several incredible things for the cause of dietary supplement freedom. The first affected the FDA’s ability to remove a product simply because it contended that the product was not safe.

Prior to DSHEA, if the FDA wanted to take the position that a particular supplement or ingredient was not safe, it could simply ban the product. The burden of proof to establish safety was imposed upon the manufacturer or marketer. As you can well understand, the compilation of safety data is a very expensive undertaking. Consequently, many of the smaller companies were not able to meet this burden, and thus, the public was deprived of many dietary supplements and fair competition.

DSHEA dramatically alters the balance of power in that dietary supplements are effectively presumed to be safe. The burden has shifted from the industry to the government to establish that a particular product is NOT safe. Unless the FDA can sustain this burden of proof, a product cannot be banned.

Stevia is a great example of the FDA’s misuse of power. Prior to 1994, the FDA banned its use in any food product. While it is still banned for use in conventional foods, it is permissible for use in dietary supplements as long as it is not used for a technical effect. Stevia presents a very interesting window into the FDA. The FDA has not attempted to ban stevia for use in dietary supplements. Clearly, if the agency thought that the existing evidence was sufficient to sustain its burden of proof, it would have done so already. The fact that is has not, is indicative of the fact that even the FDA itself does not believe sufficient evidence exists to assert that stevia is not safe. Notwithstanding this lack of science-based evidence, the FDA continues to maintain that it is not safe for conventional foods.

Exemption from Labeling – The second area in which the cause of supplement freedom was advanced was in the use of books, articles, and other publications regarding particular nutrients. Prior to DSHEA, the FDA took the position, that anything that was used to promote the sale of a product constituted “labeling.” For example, a study by Harvard Medical School that discussed the relationship between antioxidants and cancer. Consistent with its findings that what we needed was more information about the relationship between nutrition and health rather than less information, and that consumers should be empowered to make choices based on information from scientific studies, Congress expressly exempted certain materials from the definition of labeling.

DSHEA provides that a publication, which is reprinted in its entirety, shall not be defined as labeling when used in connection with the sale of a dietary supplement to consumers when it

(1) Is not false or misleading;
(2) Does not promote a particular manufacturer or brand of a dietary supplement;
(3) Is displayed or presented, or is displayed or presented with other such items on the same subject matter, so as to present a balanced view of the available scientific information on a dietary supplement;
(4) If displayed in an establishment, is physically separate from the dietary supplements; and
(5) Does not have appended to it any information by sticker or any other method.

So, if a publication meets these five criteria, I encourage people to make maximum use of it. Hand out copies to everyone. Use it for wall paper.

Statements of Nutritional Support – Prior to DSHEA, if a supplement manufacturer or marketer even hinted that there was a relationship between a nutrient and a disease, the FDA would stop him. That changed with DSHEA. DSHEA expressly authorized four types of claims.

1. Claims related to a classical nutrient deficiency disease;
2. General well-being claims;
3. Claims that describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans;
4. Claims that characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function.

As you know, nutrients affect every structure and every function of the body. The ability to explain this to consumers is another huge victory. Moreover, many diseases are directly related to a degeneration of a structure, or the malfunction of a function. So the ability to make such claims allows supplement marketers to educate consumers about such diseases.

Progress in the Cause of Supplement Freedom

Court cases

Pearson v. Shalala was the first significant case to challenge the FDA’s arbitrary and capricious denials of industry-proposed health claims. The plaintiffs in the Pearson case were dietary supplement manufacturers and trade associations representing manufacturers and retailers.

Under the NLEA, an interested party may petition the FDA to seek approval of a particular health claim. The requirement that health claims be approved before being added to the label of a dietary supplement constitutes the primary regulatory hurdle faced by marketers of dietary supplements.

The plaintiffs submitted 4 health claims to the FDA for approval.

(1) “Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers.”
(2) “Consumption of fiber may reduce the risk of colorectal cancer.”
(3) “Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease.”
(4) “0.8 mg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form.”

Not surprisingly, the FDA denied all four claims.

The court found that the FDA’s concerns easily could be accommodated by adding a prominent disclaimer to the label. The court specifically stated that, “…more disclosure rather than less is the preferred approach, it is clearly in the public interest to ensure that governmental agencies, such as the FDA, fully comply with the law, especially when that law concerns the parameters of a party’s First Amendment rights to effectively communicate its health message.”

The court held the FDA’s denials in suppressing the Plaintiffs’ claims, rather than proposing a clarifying disclaimer to accompany the claims, violated the Constitution of the United States, specifically the First Amendment that guarantees freedom of speech.

Under the Pearson decision, completely banning a health claim is reasonable only if the FDA has found NO evidence that supports the claim, or if the evidence in support of a health claim is weaker than the evidence against the claim.

The FDA was also directed to relax its “significant scientific agreement” standard in order to permit a broader range of health claims, as long as they are accompanied by a disclaimer.

Whitaker v. Thompson

In May of 2001, the FDA rejected a claim which stated, “Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancer.” This claim was almost identical to the claim in the Pearson case.

In December of last year, a federal court held that the FDA’s rejection of an antioxidant/cancer risk reduction health claim failed to satisfy the conditions that permit a ban of the claim because evidence exists supporting the fact that antioxidants DO reduce the risk of cancer.

After reviewing the studies the FDA used to reject the antioxidant claim, the court pointed out that one-third of the 150 studies considered by the FDA supported the antioxidant vitamin/cancer relationship. It was undisputed that the FDA identified some evidence in support of the antioxidant vitamin claim. Therefore, a complete ban of the claim could not be justified. The court wrote, “The FDA has failed to recognize that its decision to suppress the plaintiff’s antioxidant vitamin claim does not comport with the First Amendment’s clear preference for disclosure over suppression of commercial speech.”

As the Pearson and the Whitaker cases demonstrate, the FDA has a rich history of animosity to dietary supplements and natural health. Notwithstanding the FDA’s imperial agenda, Congress has made its intent clear, and the courts are forcing the FDA to change its ways.

FDA Allowed Qualified Health Claims

The FDA is getting the message!

Selenium and Cancer Risk Reduction – Health claims linking selenium supplements with reducing cancer risks are now permitted by the FDA through its “enforcement discretion.” The agency will allow products to state on labels and in labeling that “Selenium may reduce the risk of certain cancers” or in the alternative, “Selenium may produce anti-carcinogenic effects in the body.” The claim must be accompanied by the qualifier “Some scientific evidence suggests that consumption of selenium may reduce certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive.”

Plant Sterol and Stanol Esters and Reduced Risk of Coronary Heart Disease – In February of this year, the FDA indicated that it would allow health claims regarding plant sterol or stanol esters and reduced risk of coronary heart disease.

Attempts to Erode DSHEA

Enemies in Congress

Senator Richard Durbin (Democrat, Illinois):

• Was formerly the Chairman of the Government Affairs/Oversight of Government Management Sub-committee. He presided over many hearings on the dietary supplement industry. Fortunately, he lost his chairmanship in last November’s elections.
• Is pushing for stricter labeling standards for dietary supplements.
• In October of last year, held hearings on ephedra and asked the FDA to remove it from the market.
• His office has said, “We think we need to retool the DSHEA.”
• On March 26, Senator Durbin introduced the “Dietary Supplement Safety Act.” The proposed Act requires supplement products that contain any kind of a stimulant to by approved by the FDA. If the bill passes, manufacturers would be required to submit data showing that their ingredients do not cause serious side effects when taken as directed. As you know, it costs a tremendous amount of money to conduct safety studies, which means that small and medium-sized manufacturers would not be able to comply.

Ephedra

Representatives John Sweeney (R-N.Y.) and Greg Walden (R-Ore.) announced plans earlier in the year to challenge ephedra’s safety and address restrictions on its sale following the death of professional baseball player Steve Bechler.

Sweeney sent a letter to the FDA asking it to “suspend all sales of ephedra until Congress has hearings and views evidence with regard to the immediate safety risk involved with its use. Ephedra is a dangerous substance and it shouldn’t be available over-the-counter. The Major Leagues should ban its use in baseball and I’ll make sure Congress ends its sale over-the-counter.”

On March 4, Sweeney and Walden introduced a bill called the “Ephedra Public Protection Act,” which would ban the sale of all ephedrine alkaloid-containing dietary supplements under most conditions.

On February 28, the House Energy and Commerce Committee launched an investigation into the safety of ephedra. Letters have been sent to numerous manufacturers and marketers of ephedra dietary supplements demanding a variety of information. Hearings by the full committee will probably be held in the next several months.

States and Ephedra

• New York – A bill to ban the sale of ephedra supplements except for drugs under FDA supervision has been introduced in the New York Assembly.
• Banned in a couple of states, and many are proposing to do the same.

The American Medical Association

Significant Scientific Agreement Standard – The FDA has since promulgated 21 C.F.R. § 101.14 – the “significant scientific agreement” “standard” (quoted above) – and 21 C.F.R. § 101.70 – a “procedure” (not particularly relevant to this case) – for evaluating the validity of health claims on dietary supplements.

A New Standard – “Weight of the evidence” v. “significant scientific agreement.”

The American Medical Association “strongly opposes” the FDA’s decision to allow “weight of the evidence” standard. The AMA contends that the new standard would allow the use of health claims “that have a reasonable chance of being erroneous” and “actually could confuse consumers” rather than help them to make informed decision. The AMA says it is working with Congress to amend DSHEA.

We tend to think that the pharmaceutical industry is the only enemy in this battle. It should come as no surprise that the very powerful medical industry is a close ally to big pharma.

Conclusion

Trends

• There seems to be an increasing desire on the part of a very small minority of the more liberal legislators in Congress to amend DSHEA.
• In DSHEA, Congress has made its intent clear. It has spoken. The whims of a few radical legislators will not derail the progress that has been made.
• The courts clearly like DSHEA and are intent on protecting freedom of speech and the health of the people.
• The FDA has consistently lost court cases.
• The FDA’s decision to allow selenium and cancer risk reduction claims is perhaps representative of a new level of cooperation between the agency and the nutrition industry regarding health claims.

What we are seeing in the U.S.

There is a powerful movement in the U.S. away from drugs and conventional health care to preventative natural health care.

There is an equally powerful desire on the parts of legislators and courts to ensure that the public has free access to information about dietary supplements are their abilities to prevent and treat diseases.

Similarly, there is a powerful momentum to ensure that the public has increasing access to all types of dietary supplements.

The age-old problem still remains – Just because something is true, doesn’t mean you can say it.

Nevertheless, the fight for vitamin freedom is going well in the U.S., and we are winning.

The pharmaceutical industry is losing ground in the U.S. However, it did not gain power over night, and it will not lose power overnight.

A lot of dietary supplement freedom has been won in the U.S., but it is constantly being threatened

Comparatively speaking, there is vastly less supplement freedom elsewhere in the world. That needs to change.

By virtue of your participation in this Tribunal, you are privileged to have knowledge that not many in the world have. Knowledge, however, that is not applied is useless.

I want to challenge you to put that knowledge into action. There is a war that is raging even now. It’s not a war of military might. As Dr. Rath has pointed out, it’s a war between truth and deception.

Protecting our hard won freedoms means getting involved! I want to challenge you to suit up, and get in the game. It’s time to play offense!

“Eternal vigilance and relentless action are the prices of freedom.”

If we are not vigilant, we could lose the tremendous freedoms we have gained.

Thank you all for you vigilance, and thank you Dr. Rath for your vigilance, your passion, and your relentless willingness to act.