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Volume 38, No. 2

Assessing claims of functional foods and nutritional supplements

Report on Health Journalism 2010

Neil Levin was an invited representative of the American Nutrition Association.  He participated in a conference panel at Health Journalism 2010, held at McCormick Place in Chicago on April 24, 2010. The following is his reporting on the conference:

Assessing claims of functional foods and nutritional supplements
This panel, moderated by Bianca Alexander, chief executive officer, Conscious Planet Media, will take a deeper look at one of the most controversial issues today – the often unregulated health claims of so-called functional foods and nutritional supplements. With more and more products on the market claiming to have health benefits for the consumer, this panel will help you better understand how to evaluate these claims and separate fact from fiction. We will hear from experts who will shed light on the federal and state regulatory landscape covering these issues, as well as strategy and recent data to help you tackle functional food coverage with more accuracy and integrity.

I took notes and wanted to explore some of the issues and controversies that arose during the panel discussion. First, each panelist made a 15-minute presentation, followed by a Q & A session. Here are some of the highlights that I discerned from their presentations.


Bruce Silverglade, legal director of the Center for Science in the Public Interest (CSPI), made these points in his slides:   

  • There is no legal definition of “functional” foods and vitamin-mineral fortified foods have been around for decades
  • Some functional foods are useful
    • Enriched oatmeal
    • Calcium fortified OJ
  • Foods with novel ingredients, such as margarines with plant stanol esters, must meet FDA food additive rules or have GRAS status and meet FDA Health Claim rules
  • Most currently available “functional” foods do not address major public health problems, only minor ones
  • These Functional food product claims are dubious:
    • Energy drinks
    • Herbs added to beverages
    • Snacks
    • Immunity
  • The FDA has been increasing enforcement actions recently. Most involved medical claims, not structure-function claims.
    • Misleading structure function claims:
      • Ocean Spray® Cranberries (“help cleanse and purify your body”)
      • DanActive™ dairy-based probiotic supplement beverage (“helps strengthen your body’s defenses”)
  • “While existing laws for health claims and food additive approvals are adequate, the FDA needs to update its enforcement policies to keep control of the marketplace”
  • For foods (dietary supplements already have these rules), CSPI wants a definition and pre-market notification of the use of “novel ingredients” used in fortified foods. Also for their claims, as well as a scientific standard for claims.
  • Novel ingredients should meet the FDA’s fortification policy and not be added to foods of low nutritional value.
  • There should be no distinction between structure-function claims and Health Claims, since consumers don’t “get” the difference. Both types of claims should be allowed based only on “Significant Scientific Agreement”, not industry selected studies.
  • Functional foods “must be regulated under the food safety and labeling laws, and not under laws pertaining to dietary supplements”
  • “Dietary supplements are subject to their own regulatory regime established by Congress (DSHEA)”
  • Mr. Silverglade also made these points verbally:
  • Functional foods are around because of DSHEA, the Dietary Supplement Health and Education Act of 1994: “…dietary supplements, in our view, were essentially deregulated in 1994 by Congress” and DS Companies since 1994 were not required to prove safety before the product was sold if the product was in use before 1994 in the United States
  • Congress allowed “structure-function (S-F) claims” for dietary supplements that don’t require FDA approval or substantial scientific agreement and federal rulemaking, as applies to food claims
  • The food industry watched dietary supplement sales rise with the use of S-F claims and started utilizing them instead of applying for FDA-approved health claims, creating a new category of “functional” foods with no legal definition
  • CSPI has much larger concerns with the food industry because it is much larger than the DS industry and everybody eats
  • FDA has not cracked down on companies making S-F claims, as CSPI has requested, though the agency has cracked down on other food labeling violations such as health claims
  • Because we overeat in America, there are no vitamin deficiencies in the US that would lead to immune deficiencies and we don’t need to consume the additional vitamins in functional foods, which would not improve the immune system of Americans
  • FDA should enforce the law; we don’t need new laws

     


Marilynn Marchione, AP Medical Writer, made these points in her handout:

  • Many functional foods are “little more than dressed-up junk food”
  • We should be concerned about consuming “too much of certain nutrients, plus too many calories and fats”
  • The FDA “is paying more attention to health claims on functional foods”
  • Claims that fortified foods can “boost immunity” are vague with little science for back up
  • Benefits of marine omega-3 fats (providing the fatty acids EPA and DHA) are being claimed by plant sources containing a similar but different fatty acid, ALA
  • Overconsumption of calories and a misguided focus on individual nutrients over whole foods are some of the main concerns

    She made these points in her verbal presentation:

  • Add sugar to water, and you can make an all natural energy drink that supplies essential nutrients
  • Wellness products fill a “deep emotional need” for personalized care, for control over one’s health, or to quench a fear of a dreaded disease
  • DS are a big industry
  • Don’t be taken in by marketing and anecdotal stories
  • Don’t suspend normal skepticism, objectively present facts
  • Beware cultural defensiveness (don’t accept that a product is widely accepted in another culture despite lacking science)
  • DS do not have to be proven safe before they are sold
  • Natural products can contain unwanted natural substances (lead or arsenic)
  • Natural products can interfere with medical treatments such as drugs
  • Natural products can have biological effects, good or bad
  • Quality is an issue; Consumerlab found 25% of products tested failed their criteria
  • National Center for Complementary Medicine spent $2.5 billion over 10 years and few natural products work
    • Don’t work: Ginkgo for memory, Echinacea for colds, Glucosamine and Chondroitin for arthritis, Black cohosh for menopausal hot flashes, Saw Palmetto for prostate problems, shark cartilage for cancer
  • Studying herbals is tough as they’re not standardized
  • Placebos work: 30% response rate
  • Test tube and animal studies aren’t enough; if we required clinical studies for DS claims it would give better assurance of safety and efficacy
  • DS claims use “weasel wording” language and claims of a product to support the immune system is a “quack concept” (cell-to-cell communication, increases Natural Killer cell activity)
  • Candy bars and junk foods enriched with nutrients are still junk foods
  • No proof that probiotics remain viable after freezing
  • There’s evidence that for some people, vitamins can be harmful; too much for some people can be deadly
  • Many claims are vague
  • “Most supplements have not been proven to be safe and effective. Asked to take a drug under those terms, how many of us would? Should it be any different for supplements?”

 


Neil E. Levin, C.C.N., D.A.N.L.A., programs chair, American Nutrition Association; nutrition education manager, NOW Foods

Since I had the last 15-minute presentation of the 3 panelists present, I made it a point to praise and agree with some of the statements made by the earlier speakers. Here are my points:

  • As I began my presentation I first agreed with certain statements by the previous speakers:
    • Functional food claims should be regulated
    • We don’t need new laws, we need to enforce the current laws
    • Agency priorities and resources have always been an issue in regulation
    • Natural doesn’t necessarily mean something is safe or effective
      • There is a bias that natural can be better utilized and is safer, but that’s not always true
    • They don’t require safety approval premarket
    • They can have side effects and interactions
    • Test tube studies don’t prove that the same effect will happen in the human body
    • Structure-function claims should primarily be based on human clinical studies
    • Be skeptical; bring the same skepticism to DS critics (medical interests, drugs, medical journals) as DS companies
  • Topics I cover in my presentation:
    • Are DS Safe?
    • Are DS Adequately Regulated?
    • What claims can be legally made for DS?
    • How can journalists present balanced information?
  • Resources
    • Lots of confusion in Nutritional Science
    • Poor training, misinformation
    • PR campaigns push sensational reports
    • Scientific journals/researchers are not always unbiased
    • Poor study design
    • “Land of Confusion” in the Journal of Applied Nutrition addresses these root issues
  • Journalists may lack fact-checking resources to review reports
    • At the same time, there are many new sources of information to filter
  • Are Dietary Supplements Regulated?
    • I pointed out headlines by the New York Times, Medical Journals, and the GAO  claiming that supplements are “unregulated”
    • I also pointed out the FDA website where the agency explains how it regulates DS
    • DSHEA requires manufacturers to follow federal GMPs
      • As of May 2010, GMPs now cover every American manufacturer and require identity and safety testing on each raw material
    • DSHEA continues to define DS as a food category, though a specially regulated one
    • DSHEA regulates DS label claims
    • DSHEA prohibits mislabeled, adulterated products
    • FDA Commissioners regularly testify that they have adequate power to regulate the DS industry under current laws
  • Grandfathering products without safety or efficacy approvals
    • The 1938 FDC Act grandfathered in drugs already on the market, exempting them from the usual drug application process
    • The 1962 FDC Act amendment also had a grandfather clause for drugs already on the market
    • DSHEA had a similar grandfather clause, approving existing DS ingredients as of October 15, 1994 and requiring pre-market notification of New Dietary Ingredients to the FDA
  • Dietary Supplement Safety
    • CDC reports estimate that foodborne diseases cause 76 million illnesses, 325,000 hospitalizations and 5,000 deaths in the US each year
    • Adverse Event Reports for Drugs are approaching 500,000 annually
    • In 2008, the first year of mandatory reporting, the FDA received less than 1,000 Dietary Supplement AERs, fewer than anticipated
    • Mayo Clinic published a report on its patients, concluding that a small number of prescription meds and a small number of DS accounted for most of the drug-nutrient interactions with no serious interactions and reporting that “the actual potential for harm was low.”
    • The American Association of Poison Control Centers’ latest annual report listed zero deaths from DS in 2008, the most recent year reported
    • Another toxicology journal report on a one-year poison center surveillance project concluded that “most supplement-related adverse events were minor” and the most problematic were caffeine and products containing the herb yohimbe
    • Bias: a peer-reviewed study reported that increased pharmaceutical advertising is associated with scientific journals publishing fewer articles about DS and publishing more articles with conclusions that DS are unsafe
  • FDA Regulated Health Claims
    • It’s not legal to market a DS as a treatment or cure for a specific condition
    • Claims are limit to 3 kinds:
      • Health Claims: The 1990 Nutrition Labeling and Education Act (NLEA) authorized FDA to issue regulations governing Health Claims for both foods and DS; the 1997 Food and Drug Administration Modernization Act (FDAMA) allows for health claims based on authoritative statements by the NAS or US government scientific bodies; the 2003 FDA Consumer Health Information for Better Nutrition Initiative provides for Qualified Health Claims backed by less authoritative evidence
      • Qualified Health Claims allowed for Foods include ones regarding the role of various healthy fats in reduced heart disease risk
      • Qualified Health Claims allowed for DS include Calcium, Green Tea and Antioxidants to reduce the risk of certain cancers, Omega-3 Fatty Acids for CHD, B Vitamins for reduced Vascular Disease risk and Folic Acid to prevent Neural Tube Birth Defects
      • Approved Health Claims allowed for Foods include the benefits of Fiber and Sugar Alcohols
      • Approved Health Claims allowed for DS include Calcium and Vitamin D against osteoporosis, Soy Protein reducing the risk of cardiovascular disease (CVD), and Stanols/Sterols and the risk of CVD
  • Structure-Function Claims: In 1994 DSHEA authorized FDA to set rules for Structure-Function claims, which the agency reports have historically appeared on labels of foods, drugs, and DS and which “characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function or may describe general well-being from consumption of a nutrient or dietary ingredient”
    •  “Calcium builds strong bones”
    •  “Fiber maintains bowel regularity”
    • S-F claims must carry disclaimers that the FDA has not evaluated the claim and that the product is not intended to “diagnose, treat, cure or prevent any disease” (under DSHEA, those are drug claims)
  • Nutrient Content Claims:
    • Characterize the level of a nutrient in a food with descriptive words such as free, high, low, more, reduced, lite.
  • Enforcement
    • The FDA routinely publishes warning letters sent to companies that have violated these labeling laws and regulations, posted on the agency website as “Inspections, Compliance, Enforcement, and Criminal Investigations”
  • Conclusions
    • The safety of DS is well established
    • DS are adequately regulated under current laws even if enforcement can sometimes be better
    • Illegal label claims, including websites and advertising, are being addressed by the FDA and FTC
    • Journalists need fair and balanced resources to report accurately on DS
      • Scientific and medical special interests are not necessarily accurate and impartial sources regarding DS issues
      • However, 79% of US physicians and 82% of nurses do recommend DS to their patients
      • 85% of American adults believe vitamins and mineral supplements are safe
      • 64% of American adults classify themselves as DS users
  • Independent Resources for journalists
    • American Nutrition Association
    • American Botanical Council
    • American Herbal Pharmacopoeia
    • The Natural Health Research Institute
  • Industry Resources for journalists
    • Natural Products Association
    • American Herbal Products Association
    • United Natural Products Alliance
    • Council for Responsible Nutrition

Q&A Session highlights:

  • The term “organic” is defined by the USDA, but there is no federal definition of the term “natural”
  • Mr. Silverglade said that drugs have proven benefits but DS have no proven benefits; ignoring FDA-approved health claims for DS and the fact that vitamins and minerals are considered essential dietary components that government surveys reveal are often deficient in Americans’ diets
  • Ms. Marchione incorrectly asserted that 2009 was the first year of mandatory AER reporting for dietary supplements, but as my slides made clear it was really one year earlier in 2008

View Neil Levin's Presentation from the Conference

For informational purposes only - not intended as medical advice, diagnosis or treatment, nor an endorsement by the American Nutrition Association®. Use permitted for non-profit and non-commercial uses or by healthcare professionals in their practice, with attribution to www.AmericanNutritionAssociation.org. Other use only with written ANA℠ permission. Views expressed are those of the author and not necessarily those of the ANA℠. Works by a listed author subject to copyrights as marked. © 2010 ANA℠