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Orthomolecular Medicine News Service, Jan 12, 2023

Nutrient Benefit Statements and the 2010 Legal Victory Prohibiting FDA Censorship of Qualified Health Claims

Commentary by Michael Passwater and Richard Passwater, Jr

OMNS (Jan. 12, 2023) This review takes a look back at a landmark case in the nutrition industry to illustrate the challenges of public statements related to potential benefits of nutrients and other dietary ingredients. The case of Alliance for Natural Health v. Sebelius centered around the topic of selenium and cancer prevention, but the bigger issue was and is the freedom to share scientific and medical evidence with the public.

Regardless of the nature of the business, the United States Federal Trade Commission (FTC) states all claims must be truthful, substantiated, non-deceptive, and fair. Claims related to human health also must meet criteria established by the United States Food and Drug Administration (FDA). A web of arbitrary distinctions complicates this realm: between maintaining normal health, preventing disease, and treating disease; distinctions between natural vs. prepared foods; and distinctions between what constitutes reasonable evidence for each classification of substances and statements.

The decision about adequacy of evidence to make a claim related to wellbeing is of major importance to public health. Similarly, the decision about whether a statement relates to a nutrient deficiency or to a disease state is also important, as this drives which regulatory rules apply to the evaluation of the statement. For example, is osteoporosis a disease or a vitamin and mineral deficiency?

By definition, a vitamin is a compound that must be consumed in order for a human to survive or reproduce. These compounds were identified by the development of a specific condition, historically called a "deficiency disease," that developed because of acute inadequate intake. For example, the inadequate intake of vitamin B1 leads to the development of beriberi. Similarly, insufficient vitamin B3 leads to pellagra, insufficient B6 leads to paresthesia, inadequate vitamin C leads to scurvy, and vitamin D deficiency is the leading cause of rickets which involves inadequate calcium and phosphorus in bones. Inadequate intakes of certain minerals have also been associated with the development of "deficiency diseases." Endemic goiter results from an iodine deficiency, and microcytic anemia may be the result of iron deficiency. While once associated with the prevention of a deficiency disease, today, curiously, very few disease prevention claims are allowed for these essential biochemicals.

The matter is further complicated because vitamins, minerals and other nutrients play multi-faceted and synergistic roles in wellness and recovery. Insufficient intake can directly cause certain conditions to develop and may also contribute to formation of other conditions. For example, insufficient vitamin C can cause scurvy, but can also impair iron absorption which may lead to iron deficiency anemia. As our knowledge of biochemistry has grown, more metabolic and hormonal pathways, genetic interactions, and interrelationships between nutrients have been discovered. It would seem natural that the list of accepted benefits associated with correcting and maintaining sufficient tissue levels of essential biochemicals would grow accordingly. Nutrients not only help maintain health and prevent deficiency related diseases, but at other times their use may help treat or manage conditions which may be considered disease states.

Vitamin C is essential for generating collagen (thereby preventing scurvy), but is also essential for proper immune system function, and has important roles in the prevention of arteriosclerosis. Niacin prevents pellagra -- but suboptimal intake is also associated with psychiatric symptoms including irritability, poor concentration, anxiety, fatigue, loss of memory, restlessness, apathy, and depression as well as abnormal blood lipid chemistry. Yet, decades after publication of the science and clinical evidence associating vitamin C with improved outcomes in viral infections, hypertension, and heart disease, and niacin with improvements in cardiovascular and mental health, it remains illegal to advertise these nutrients for such purposes.

Meanwhile, the drug aducanumab was approved by the FDA in 2021 for use in patients suffering from Alzheimer's Disease without demonstration of clinical efficacy (Cleveland Clinic and Mount Sinai have refused to provide the drug), and expensive cancer treatments have been approved by the FDA based on clinical trials suggesting prolonging life expectancy by a few weeks. [1,2] Public access to scientific and medical information is important to allow informed choices by people desiring to lead their healthiest life.

From 1992 - 1996 FDA prohibited companies selling folic acid from telling women of childbearing age that 0.4 mg of folic acid daily before pregnancy could reduce the incidence of neural tube defects, including spina bifida and encephalopathy by 40%.

From 1994 - 2000 FDA prohibited companies selling fish oils from telling Americans that fish oils could reduce the incidence of coronary heart disease.

From 2000 - present FDA prohibits companies selling saw palmetto from telling Americans that saw palmetto (containing vitamin E and other beneficial biochemicals) reduces enlarged prostates and relieves related symptoms.

From 2000 - present FDA has prohibited companies that sell glucosamine and chondroitin from telling Americans about the evidence that those dietary ingredients treat osteoarthritis and relieve osteoarthritis pain and stiffness.

FDA also claims it is unlawful to tell the scientific truth that niacin lowers elevated blood cholesterol.

Fighting against this unhealthy blockade of sound science, attorney Jonathan Emord practices food and drug law, deceptive advertising law, and libel law, and he served as lead counsel in several cases holding FDA censorship of nutrient-disease relationship claims unconstitutional: Pearson v. Shalala (D.C. Cir. 1999); Pearson v. Shalala (D.D.C. 2001); Pearson v. Thompson (D.D.C. 2001); Whitaker v. Thompson (D.D.C. 2001); Whitaker v. Thompson (D.D.C. 2002); and ANH v. Sebelius (D.D.C. 2010). [3]

The Confusing Landscape of Statements of Health Benefit

1. Statements of Nutrition Support (aka Structure Function (S/F) claims) - Structure Function claims address a substance's impact on a structure or function of the body. S/F claims cannot involve prevention or treatment of a disease and must carry the FDA disclaimer that FDA does not approve the claim and the product is not intended to treat or prevent a disease. Examples: "Vitamin C helps support a healthy immune system", "Melatonin promotes restful sleep."
2. Health Claims - Relate a substance to a disease or health-related condition, and are limited to claims about disease risk reduction; Cannot be claims about the diagnosis, cure, mitigation, or treatment of disease. "Authorized" Health Claims must have "significant scientific agreement" as determined by the FDA. Example: "Low fat diets rich in fruits and vegetables (foods that are low in fat and may contain dietary fiber, vitamin A, and vitamin C) may reduce the risk of some types of cancer, a disease associated with many factors. Broccoli is high in vitamins A and C, and it is a good source of dietary fiber."
3. Qualified Health Claims - Must have scientific support but do not require "significant scientific agreement". [4] Qualified health claims include a disclaimer by the FDA. Example: "Selenium may reduce the risk of certain cancers. Some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive."
4. Medical Foods - A different regulatory class that allows a link between a product and treating a disease or condition. Medical Foods are a specially formulated and processed product (as opposed to a naturally occurring food) intended for the dietary management of a patient with special medically determined nutrient requirements which cannot be achieved by the modification of the normal diet alone; Medical Foods are intended to be used only for a patient receiving active and ongoing medical supervision. Example: a commercially available powdered drink contains arginine, collagen protein, glutamine, HMB (β-hydroxy β-methylbutyrate), zinc, and vitamins C, E, B12, and qualifies as a "medical food" that may be marketed as a "therapeutic nutrition intervention to support the healing of pressure injuries and wounds caused by trauma or surgery." [6]
5. Drugs - articles intended to diagnose, treat, or prevent disease are classified as drugs (unless they meet the classification for a medical food). An Investigational New Drug (IND) application must be filed with the FDA, and the FDA must review and approve safety, efficacy, labeling, and marketing aspects of the product before it can be sold. https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application
6. Practice of Medicine - The practice of medicine is not regulated by the FDA. States define and regulate the practice of medicine. Generally, attempts to diagnose a patient, treat medical conditions, prescribe medications or treatments, or perform surgery is considered engagement in the practice of medicine.

The FDA picks the wrong fight: FDA Notice of Changing Selenium Qualified Health Claims

1. In 2003, FDA granted two Qualified Health Claims for selenium and certain cancers. (Qualified Health Claim: Final Decision Letter) Docket No. 2002P-0457
2. On December 21, 2007, FDA published notice that it would re-evaluate the evidence regarding selenium and cancer. [Federal Register 72 (245) 72738 - 72740 (Dec 21, 2007)]
3. FDA stated that it was undertaking a reevaluation of the scientific basis for these qualified health claims because of new scientific evidence that emerged for these substance-disease relationships. FDA referred to a May 2006 report of the Agency for Healthcare Research and Quality (AHRQ) as the only newly emerged scientific study of selenium and cancer. However, to the contrary, the AHRQ report supported a "moderate" anti-cancer effect of selenium-containing nutrients.
4. In March 2008, Richard Albert Passwater, PhD, and Gerhard Schrauzer, PhD independently responded to the FDA's public comment period with petitions citing over 150 references, including 16 human intervention trials and 50 human observation studies of selenium and one or more cancers. (Docket No. FDA-2008-Q-0323)
5. June 2009, FDA announced the denial of new qualified health claims and made restrictions to the existing qualified health claims. In Dr. Passwater's words, "The only logical course of action was to sue the FDA to have the courts order the FDA to comply with the law and the Constitution." The lawsuit was filed July 31, 2009. Attorneys Peter Achangelsky, Chris Niederhauser, and Jonathan Emord prosecuted the case. Of note, most qualified health claims for nutrients have only been allowed following lawsuits against the FDA's censorship of them.
6. May 27, 2010, District Court in Washington, DC ordered the FDA to take corrective action to restore First Amendment protection and allow reasonable and truthful health claims. [7,8]

While preserving and adding to the list of specific qualified health claims for selenium and cancer prevention, the lawsuit's greater importance was the protection of First Amendment rights and the general concept of truthful health claims. Jonathan Emord commented, "I cannot overstate the importance of ANH v. Sebelius (2010). Judge Ellen Huvelle brilliantly reaffirmed Pearson v. Shalala (1999) and made clear, for the first time in any federal decision, that FDA cannot lawfully saddle claims with false, misleading or verbose qualifications." [3]

Passwater: Did FDA abide by the Court orders in the previous cases?

Emord: No. In fact, an FDA official told me about a year after the landmark Pearson v. Shalala (1999) decision issued that FDA would "never ever, ever" abide by that order. When I heard the official say those words, a very cold and stark reality came upon me. FDA views itself above the law. There can be no rule of law, no protection for civil liberties, and no limits on government power when an agency of the federal government is lawless, and FDA has proven itself lawless repeatedly. As it turns out, tragically, that official was right. FDA has never adhered to the letter or spirit of that landmark decision. That was a final and binding constitutional mandate on the agency, yet FDA refuses to follow the requirement that it favor disclosure of health information over suppression as its operative rule. It does the opposite. It favors suppression as the rule and disclosure as the rare exception. [3]

The FDA and other Federal agencies have been referred to as "the 4th branch of the Federal government". These agencies produce thousands of rules per year, receive significant funding from companies they are charged with regulating, and have little accountability to the American public they are charged with protecting. The public can indirectly influence these agencies through the election of the United States President. The only mechanism for direct accountability of these agencies to the public is through expensive and time-consuming lawsuits. [9]

Protecting the public from medical harm and harmful misinformation is a daunting and noble task. Protecting the public from the suppression of helpful information and harmful, even if well-intended, propagation of existing opinions is a challenging and important part of this task. When the basic practices of handwashing, outcome measures, and smoking cessation are met with "ridicule and vituperative attacks even from within the medical profession", and required half a century or more to accept, it is not surprising that acceptance of the finer points of nutrition to prevent disease and heal is challenging. [10-15]

Summary

It's 2023. Over 1,100,000 Americans have died from Covid-19. [18] Medical doctors with the highest published success rates treating intensive care patients with Covid-19 have lost privileges at hospitals where they served. [19,20] History suggests that neither the beliefs of mavericks nor the prevailing beliefs of medical and regulatory authorities are always correct. Awareness of the limitations of current scientific and medical knowledge, and openness to objective evidence is important for progress. The power and wisdom to distinguish between a reasonable statement of potential health benefit, and a false statement of potential health benefit remains an important topic. Freedom of speech, and the integrity and discipline to use it in a truthful, trustworthy manner is essential for building and sustaining a healthy society.

"I think by far the most important bill in our whole code is that for the diffusion of knowledge among the people. No other sure foundation can be devised for the preservation of freedom, and happiness." ~Thomas Jefferson to George Wythe Aug 13, 1786 [17]

(Michael E. Passwater is certified by the American Society for Clinical Pathology as a medical technologist and is a specialist in immunohematology. Richard Passwater, Jr., has more than 30 years' experience in the dietary supplement industry. He has authored over 120 articles and is the co-inventor of three patents. Both men are sons of author and Orthomolecular Medicine Hall of Fame member Dr. Richard A. Passwater.)

References and Further Reading

1. Walker J (2021) Cleveland Clinic, Mount Sinai and Providence Won't Give Biogen's New Alzheimer's Drug. The Wall Street Journal. July 15, 2021. https://www.wsj.com/articles/cleveland-clinic-mount-sinai-wont-give-biogens-new-alzheimers-drug-11626366968

2. Szabo L (2017) Treating Cancer: Hope vs. Hype. Dozens Of New Cancer Drugs Do Little To Improve Survival, Frustrating Patients. Keizer Health News. Feb 9, 2017. https://khn.org/news/dozens-of-new-cancer-drugs-do-little-to-improve-survival-frustrating-patients

3. Passwater RA (2010) "The Importance of the Health Claims Victory and Global Censorship of Health Information: An intervew with attorney Jonathan Emord". Whole Foods Magazine. November 2010. https://wholefoodsmagazine.com/columns/vitamin-connection/importance-health-claims-victory-and-global-censorship-health-information

4. Ellwood KC (2006) What are qualified Health Claims? Nutrition Today, Volume 41, Number 2, March/April, 2006. https://journals.lww.com/nutritiontodayonline/Abstract/2006/03000/What_Are_Qualified_Health_Claims_.4.aspx

5. FDA Guidance for Industry: Frequently Asked Questions about Medical Foods. https://www.fda.gov/files/food/published/Guidance-for-Industry--Frequently-Asked-Questions-About-Medical-Foods--Second-Edition-%28PDF%29.pdf

6. Juven(c) Support Wound Healing. https://www.juven.com

7. Passwater RA (2010) "New FDA Qualified Health Claims for Selenium: An interview with Dr. Gerhard Schrauzer". Whole Foods Magazine. October 2010. https://wholefoodsmagazine.com/columns/vitamin-connection/new-fda-qualified-health-claims-selenium

8. Passwater RA (2009) "Why the FDA is confused about selenium". Whole Foods Magazine. November 2009. https://wholefoodsmagazine.com/columns/vitamin-connection/why-fda-confused-about-selenium-health-claims-part-2

9. Tips SC (2022) "This may be the Supreme Court's Most Important Decision This Year: West Virginia v. EPA". Whole Foods Magazine. September 2022. https://wholefoodsmagazine.com/columns/legal-tips/this-may-be-the-supreme-courts-most-important-decision-this-year

10. Best M, Neuhauser D (2004) Ignaz Semmelweis and the birth of infection control. Qual Saf Health Care 13:233-234. https://pubmed.ncbi.nlm.nih.gov/15175497

11. Dowling WC (2006) Oliver Wendell Holmes in Paris: Medicine, Theology, and The Autocrat of the Breakfast Table (Durham, NH: University of New Hampshire Press, 2006), 95 ISBN-13: ‎ 978-1584655800

12. Lane HJ, Blum N, Fee E (2010) Oliver Wendell Holmes (1809-1894) and Ignaz Philipp Semmelweis (1818-1865): preventing the transmission of puerperal fever. Am J Public Health. 100:1008-1009. https://pubmed.ncbi.nlm.nih.gov/20395569

13. Brand RA. (2009) Ernest Amory Codman, MD, 1869-1940. Clin Orthop Relat Res. 467:2763-2765. https://pubmed.ncbi.nlm.nih.gov/19690929

14. Chun J, Bafford AC (2014) History and Background of Quality Measurement. Clin Colon Rectal Surg. 27:5-9. https://pubmed.ncbi.nlm.nih.gov/24587698

15. Blum A (1999) Alton Ochsner, MD, 1896-1981 anti-smoking pioneer. Ochsner J. 1:102-105. https://pubmed.ncbi.nlm.nih.gov/21845126

16. Thomas Jefferson's Monticello: Jefferson Quotes and Family Letters https://tjrs.monticello.org/letter/1283

17. Coronavirus in the U.S.: Latest Map and Case Count. The New York Times. Accessed Nov 23, 2022. https://www.nytimes.com/interactive/2021/us/covid-cases.html

18. Jane Harper (2021) "Norfolk doctor suing Sentara has hospital privileges suspended". The Virginian-Pilot. November 23, 2021. https://www.pilotonline.com/news/health/vp-nw-sentara-doctor-suspended-20211123-5y7uhc6n5rffticae2a47zqjiu-story.html

19. https://covid19criticalcare.com

20. Waldstein A (2022) Common Practitioner Pitfalls to Avoid When Marketing Dietary Supplements. Townsend Letter 472. https://www.townsendletter.com/article/472-labels-claims-and-suggestions

The Foundation for Health Research https://foundationforhealthresearch.org/articles/covid-19-the-science-we-should-know

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