American College of Physicians: Internal Medicine — Doctors for Adults ®

Thursday, May 21, 2015

Is the FDA unKIND?

Chances are, if you have ever ventured just about anywhere outside of your own house, that you are familiar with the increasingly ubiquitous KIND bars. And chances are as well, if that place you call home is anywhere other than under a large rock, you are now aware of KIND's kerfuffle with the FDA.

The FDA is wrong.

Let's be clear: I am a supporter of the FDA. A former commissioner of the agency, and subsequently our former dean of medicine at Yale, is a highly respected colleague and personal friend. I have friends working at the agency now. I have advocated for the agency in various ways on many occasions, visited with scientists there for various reasons, and signed petitions in defense of the funding the agency needs and deserves to do its demanding and important work. But that doesn't change the conclusion here: The FDA is wrong.

I hasten to note that I am also a supporter of KIND. The CEO of KIND, Daniel Lubetzky, is also a personal friend, and quite literally one of the best people I know. Leaving aside the usual stuff, loving husband, devoted father, and the like, Daniel has been recognized repeatedly, and appropriately, as a paragon of corporate responsibility. He has made doing the “KIND” thing intrinsic to his company's DNA. He runs a global non-profit devoted to, of all things, world peace. I love this guy, and I love the company that embraces his exemplary commitment to honesty, integrity, and genuine virtue.

I append, as well, that KIND has sponsored 2 studies in my lab, both resulting in peer reviewed publication (the second paper is now in press). But let's be clear: I did not decide I liked KIND because the company funded research in my lab. Rather, they funded research in my lab after I decided I liked them, felt their product deserved to be studied for its health effects, and approached them about sponsorship.

In general, all the wrong concerns tend to be raised about research sponsorship. Anyone who thinks a vested interest should never fund research is something of a hypocrite if they have ever been to a pharmacy; virtually every drug at our disposal got there via pharmaceutical industry research funding.

What matters to the reliability of research findings is the methods that guard against bias, not the existence of bias in funder, or researcher. I have been biased, meaning I was hoping for a particular outcome, with every study I have ever run, whether the bills were paid by a foundation, a company, the NIH, or the CDC. Why run a study when you don't care how it turns out? I always care, and that, by definition, is bias. We thus build in methods to make sure such inevitable researcher bias does not result in biased research measures.

As for the outcome of those KIND bar studies: Both were positive, demonstrating benefits related to cardiometabolic health, appetite, weight and body composition. The science we have lines up quite well with both common sense, and the company's intentions: These are healthy snacks.

Which brings us back to the conflict with the FDA. In brief, KIND received a letter of reproach from the FDA for use of the word “healthy,” on the back and in small print, on 4 of their snack bar wrappers which in a very specific way fail to qualify, under the FDA definition, for use of that descriptor. What particular way? They exceed the allowable gram of saturated fat per serving.

I have addressed the topic of saturated fat before, more than once, and will spare us any lengthy excursion into those weeds on this occasion. Suffice to say that I agree an excess of saturated fat intake remains a common and relevant concern in the typical American diet, and that FDA rules to help defend against that excess make sense in principle.

But in this case at least, not in practice. The intent of the regulatory language is clearly to guard against the addition of saturated fat per se, as cream, butter, or oil, to a processed food recipe. The pros and cons of that approach could be debated, but it is defensible.

The fat in the KIND bars comes primarily from the nuts, notably almonds, which are a major ingredient. So, for instance, KIND almond and apricot bars have 10 grams of total fat, and 3.5 grams of saturated fat, coming mostly from the first ingredient, almonds, with some fats coming from the second ingredient, coconut (coconut is the primary source of saturated fat in this bar).

This begs the obvious question: If the fat (and saturated fat) in these KIND bars is the reason they can't be called “healthy,” and if this fat (and saturated fat) is entirely, or nearly so, from almonds, does this mean that almonds shouldn't be called “healthy”?

Any such notion is, of course, absurd. There is a voluminous, robust scientific literature (see citations below) showing that almonds, walnuts, and nuts in general confer consistent and quite significant health benefits. Regular intake of nuts has even been associated with a marked reduction in all-cause mortality risk. If that is not the very definition of “healthy” food, I have no idea what could be.

So what's really going on here? The failure of one-size-fits-all-regulation to, in fact, fit all; and the ineluctable law of unintended consequences.

The FDA is a federal agency, and its principal tool is regulatory rules. Dealing with the entire expanse of food and drugs, the FDA tools tend toward the blunt, rather than the surgically sharp. While a numerical threshold for saturated fat as an added ingredient might make some sense, it makes no sense to apply that same regulation to a wholesome, whole food ingredient known to have a healthy overall portfolio of fat content, and decisively good health effects. When almonds, as the first ingredient in a snack, are the reason that snack cannot be called “healthy,” you are well into the realm of unintended consequences. I can pretty much guarantee no such occurrence was envisioned when the regulatory language was drafted.

In addition to nuts, by the way, that same standard threshold for saturated fat would preclude calling hummus, wild salmon, or raw avocado ”healthy.” With all due respect to my friends with the feds, that's, well, nuts.

One more thing to chew on here. Does anyone think that some agent at the FDA with nothing better to do just suddenly, and spontaneously, decided to scrutinize the back of KIND bar packages on the off chance something in the fine print had gone unnoticed? I don't. I have no inside information here, but I can read the writing on the wall, as well as on a food wrapper. KIND has, as noted, grown all but ubiquitous, and for good reason. While such success fosters many claims of friendship, it fosters even more disgruntled adversaries among competitors losing market share to you. I am pretty sure some such party, looking for any way to slow KIND's momentum, legitimate or otherwise, jangled the FDA's chain. I confess it's just conjecture on my part, but ponder as the spirit moves you.

Almonds are, in fact, healthy. Walnuts are healthy. Nuts in general, hummus, and avocado are all healthy. KIND bars, too, made principally from nuts and fruit, are healthy. If a regulation on the books precludes saying so, that doesn't make the statement untrue; it makes the regulation inappropriate as applied.

The regulation, though, is the regulation; and the FDA was just doing its job. I don't think the agency was being ... unkind. I just think they got it wrong.

Health effects of nuts, representative citations:

1: Mohammadifard N, Salehi-Abarghouei A, Salas-Salvadó J, Guasch-Ferré M, Humphries K, Sarrafzadegan N. The effect of tree nut, peanut, and soy nut consumption on blood pressure: a systematic review and meta-analysis of randomized controlled clinical trials. Am J Clin Nutr. 2015 Mar 25. pii:ajcn091595. [Epub ahead of print] PubMed PMID: 25809855.

2: Berryman CE, West SG, Fleming JA, Bordi PL, Kris-Etherton PM. Effects of daily almond consumption on cardiometabolic risk and abdominal adiposity in healthy adults with elevated LDL-cholesterol: a randomized controlled trial. J Am Heart Assoc. 2015 Jan 5;4(1):e000993. doi: 10.1161/JAHA.114.000993. PubMed PMID: 25559009; PubMed Central PMCID: PMC4330049.

3: Jamshed H, Gilani AH. Almonds inhibit dyslipidemia and vascular dysfunction in rats through multiple pathways. J Nutr. 2014 Nov;144(11):1768-74. doi: 10.3945/jn.114.198721. Epub 2014 Sep 24. PubMed PMID: 25332475.

4: Abazarfard Z, Salehi M, Keshavarzi S. The effect of almonds on anthropometric measurements and lipid profile in overweight and obese females in a weight reduction program: A randomized controlled clinical trial. J Res Med Sci. 2014 May;19(5):457-64. PubMed PMID: 25097630; PubMed Central PMCID: PMC4116579.

5: Ukhanova M, Wang X, Baer DJ, Novotny JA, Fredborg M, Mai V. Effects of almond and pistachio consumption on gut microbiota composition in a randomized cross-over human feeding study. Br J Nutr. 2014 Jun 28;111(12):2146-52. doi: 10.1017/S0007114514000385. Epub 2014 Mar 18. PubMed PMID: 24642201.

6: Ley SH, Hamdy O, Mohan V, Hu FB. Prevention and management of type 2 diabetes: dietary components and nutritional strategies. Lancet. 2014 Jun 7;383(9933):1999-2007. doi: 10.1016/S0140-6736(14)60613-9. Review. PubMed PMID:24910231.

7: Jackson CL, Hu FB. Long-term associations of nut consumption with body weight and obesity. Am J Clin Nutr. 2014 Jul;100 Suppl 1:408S-11S. doi: 10.3945/ajcn.113.071332. Epub 2014 Jun 4. PubMed PMID: 24898229; PubMed Central PMCID: PMC4144111.

8: Luo C, Zhang Y, Ding Y, Shan Z, Chen S, Yu M, Hu FB, Liu L. Nut consumption and risk of type 2 diabetes, cardiovascular disease, and all-cause mortality: a systematic review and meta-analysis. Am J Clin Nutr. 2014 Jul;100(1):256-69. doi: 10.3945/ajcn.113.076109. Epub 2014 May 21. PubMed PMID: 24847854.

9: Bao Y, Han J, Hu FB, Giovannucci EL, Stampfer MJ, Willett WC, Fuchs CS. Association of nut consumption with total and cause-specific mortality. N Engl J Med. 2013 Nov 21;369(21):2001-11. doi: 10.1056/NEJMoa1307352. PubMed PMID: 24256379; PubMed Central PMCID: PMC3931001.

10: Toledo E, Hu FB, Estruch R, Buil-Cosiales P, Corella D, Salas-Salvadó J, Covas MI, Arós F, Gómez-Gracia E, Fiol M, Lapetra J, Serra-Majem L, Pinto X, Lamuela-Raventós RM, Saez G, Bulló M, Ruiz-Gutiérrez V, Ros E, Sorli JV, Martinez-Gonzalez MA. Effect of the Mediterranean diet on blood pressure in the PREDIMED trial: results from a randomized controlled trial. BMC Med. 2013 Sep 19;11:207. doi: 10.1186/1741-7015-11-207. PubMed PMID: 24050803; PubMed Central PMCID: PMC3849640.

11: Pan A, Sun Q, Manson JE, Willett WC, Hu FB. Walnut consumption is associated with lower risk of type 2 diabetes in women. J Nutr. 2013 Apr;143(4):512-8. doi: 10.3945/jn.112.172171. Epub 2013 Feb 20. PubMed PMID: 23427333; PubMed Central PMCID: PMC3738245.

12: Katz DL, Davidhi A, Ma Y, Kavak Y, Bifulco L, Njike VY. Effects of walnuts on endothelial function in overweight adults with visceral obesity: a randomized, controlled, crossover trial. J Am Coll Nutr. 2012 Dec;31(6):415-23. PubMed PMID: 23756586; PubMed Central PMCID: PMC3756625.

13: Ma Y, Njike VY, Millet J, Dutta S, Doughty K, Treu JA, Katz DL. Effects of walnut consumption on endothelial function in type 2 diabetic subjects: a randomized controlled crossover trial. Diabetes Care. 2010 Feb;33(2):227-32. doi: 10.2337/dc09-1156. Epub 2009 Oct 30. PubMed PMID: 19880586; PubMed Central PMCID: PMC2809254.

14: Trichopoulou A, Bamia C, Trichopoulos D. Anatomy of health effects of Mediterranean diet: Greek EPIC prospective cohort study. BMJ. 2009 Jun 23;338:b2337. doi: 10.1136/bmj.b2337. PubMed PMID: 19549997; PubMed Central PMCID: PMC3272659.

15: Allen LH. Priority areas for research on the intake, composition, and health effects of tree nuts and peanuts. J Nutr. 2008 Sep;138(9):1763S-1765S. PubMed PMID: 18716183.

16: Jiang R, Manson JE, Stampfer MJ, Liu S, Willett WC, Hu FB. Nut and peanut butter consumption and risk of type 2 diabetes in women. JAMA. 2002 Nov 27;288(20):2554-60. PubMed PMID: 12444862.

17: Luu HN, Blot WJ, Xiang YB, Cai H, Hargreaves MK, Li H, Yang G, Signorello L, Gao YT, Zheng W, Shu XO. Prospective Evaluation of the Association of Nut/Peanut Consumption With Total and Cause-Specific Mortality. JAMA Intern Med. 2015 Mar 2. doi: 10.1001/jamainternmed.2014.8347. [Epub ahead of print] PubMed PMID: 25730101.

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Members of the American College of Physicians contribute posts from their own sites to ACP Internistand ACP Hospitalist. Contributors include:

Albert Fuchs, MD
Albert Fuchs, MD, FACP, graduated from the University of California, Los Angeles School of Medicine, where he also did his internal medicine training. Certified by the American Board of Internal Medicine, Dr. Fuchs spent three years as a full-time faculty member at UCLA School of Medicine before opening his private practice in Beverly Hills in 2000.

And Thus, It Begins
Amanda Xi, ACP Medical Student Member, is a first-year medical student at the OUWB School of Medicine, charter class of 2015, in Rochester, Mich., from which she which chronicles her journey through medical training from day 1 of medical school.

Ira S. Nash, MD, FACP, is the senior vice president and executive director of the North Shore-LIJ Medical Group, and a professor of Cardiology and Population Health at Hofstra North Shore-LIJ School of Medicine. He is Board Certified in Internal Medicine and Cardiovascular Diseases and was in the private practice of cardiology before joining the full-time faculty of Massachusetts General Hospital.

Zackary Berger
Zackary Berger, MD, ACP Member, is a primary care doctor and general internist in the Division of General Internal Medicine at Johns Hopkins. His research interests include doctor-patient communication, bioethics, and systematic reviews.

Controversies in Hospital Infection Prevention
Run by three ACP Fellows, this blog ponders vexing issues in infection prevention and control, inside and outside the hospital. Daniel J Diekema, MD, FACP, practices infectious diseases, clinical microbiology, and hospital epidemiology in Iowa City, Iowa, splitting time between seeing patients with infectious diseases, diagnosing infections in the microbiology laboratory, and trying to prevent infections in the hospital. Michael B. Edmond, MD, FACP, is a hospital epidemiologist in Iowa City, IA, with a focus on understanding why infections occur in the hospital and ways to prevent these infections, and sees patients in the inpatient and outpatient settings. Eli N. Perencevich, MD, ACP Member, is an infectious disease physician and epidemiologist in Iowa City, Iowa, who studies methods to halt the spread of resistant bacteria in our hospitals (including novel ways to get everyone to wash their hands).

db's Medical Rants
Robert M. Centor, MD, FACP, contributes short essays contemplating medicine and the health care system.

Suneel Dhand, MD, ACP Member
Suneel Dhand, MD, ACP Member, is a practicing physician in Massachusetts. He has published numerous articles in clinical medicine, covering a wide range of specialty areas including; pulmonology, cardiology, endocrinology, hematology, and infectious disease. He has also authored chapters in the prestigious "5-Minute Clinical Consult" medical textbook. His other clinical interests include quality improvement, hospital safety, hospital utilization, and the use of technology in health care.

Juliet K. Mavromatis, MD, FACP, provides a conversation about health topics for patients and health professionals.

Dr. Mintz' Blog
Matthew Mintz, MD, FACP, has practiced internal medicine for more than a decade and is an Associate Professor of Medicine at an academic medical center on the East Coast. His time is split between teaching medical students and residents, and caring for patients.

Everything Health
Toni Brayer, MD, FACP, blogs about the rapid changes in science, medicine, health and healing in the 21st century.

Vineet Arora, MD, FACP, is Associate Program Director for the Internal Medicine Residency and Assistant Dean of Scholarship & Discovery at the Pritzker School of Medicine for the University of Chicago. Her education and research focus is on resident duty hours, patient handoffs, medical professionalism, and quality of hospital care. She is also an academic hospitalist.

Glass Hospital
John H. Schumann, MD, FACP, provides transparency on the workings of medical practice and the complexities of hospital care, illuminates the emotional and cognitive aspects of caregiving and decision-making from the perspective of an active primary care physician, and offers behind-the-scenes portraits of hospital sanctums and the people who inhabit them.

Gut Check
Ryan Madanick, MD, ACP Member, is a gastroenterologist at the University of North Carolina School of Medicine, and the Program Director for the GI & Hepatology Fellowship Program. He specializes in diseases of the esophagus, with a strong interest in the diagnosis and treatment of patients who have difficult-to-manage esophageal problems such as refractory GERD, heartburn, and chest pain.

I'm dok
Mike Aref, MD, PhD, FACP, is an academic hospitalist with an interest in basic and clinical science and education, with interests in noninvasive monitoring and diagnostic testing using novel bedside imaging modalities, diagnostic reasoning, medical informatics, new medical education modalities, pre-code/code management, palliative care, patient-physician communication, quality improvement, and quantitative biomedical imaging.

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William Hersh, MD, FACP, Professor and Chair, Department of Medical Informatics & Clinical Epidemiology, Oregon Health & Science University, posts his thoughts on various topics related to biomedical and health informatics.

David Katz, MD
David L. Katz, MD, MPH, FACP, is an internationally renowned authority on nutrition, weight management, and the prevention of chronic disease, and an internationally recognized leader in integrative medicine and patient-centered care.

Just Oncology
Richard Just, MD, ACP Member, has 36 years in clinical practice of hematology and medical oncology. His blog is a joint publication with Gregg Masters, MPH.

Kevin Pho, MD, ACP Member, offers one of the Web's definitive sites for influential health commentary.

MD Whistleblower
Michael Kirsch, MD, FACP, addresses the joys and challenges of medical practice, including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When he's not writing, he's performing colonoscopies.

Medical Lessons
Elaine Schattner, MD, FACP, shares her ideas on education, ethics in medicine, health care news and culture. Her views on medicine are informed by her past experiences in caring for patients, as a researcher in cancer immunology, and as a patient who's had breast cancer.

Mired in MedEd
Alexander M. Djuricich, MD, FACP, is the Associate Dean for Continuing Medical Education (CME), and a Program Director in Medicine-Pediatrics at the Indiana University School of Medicine in Indianapolis, where he blogs about medical education.

More Musings
Rob Lamberts, MD, ACP Member, a med-peds and general practice internist, returns with "volume 2" of his personal musings about medicine, life, armadillos and Sasquatch at More Musings (of a Distractible Kind).

David M. Sack, MD, FACP, practices general gastroenterology at a small community hospital in Connecticut. His blog is a series of musings on medicine, medical care, the health care system and medical ethics, in no particular order.

Reflections of a Grady Doctor
Kimberly Manning, MD, FACP, reflects on the personal side of being a doctor in a community hospital in Atlanta.

The Blog of Paul Sufka
Paul Sufka, MD, ACP Member, is a board certified rheumatologist in St. Paul, Minn. He was a chief resident in internal medicine with the University of Minnesota and then completed his fellowship training in rheumatology in June 2011 at the University of Minnesota Department of Rheumatology. His interests include the use of technology in medicine.

Technology in (Medical) Education
Neil Mehta, MBBS, MS, FACP, is interested in use of technology in education, social media and networking, practice management and evidence-based medicine tools, personal information and knowledge management.

Peter A. Lipson, MD
Peter A. Lipson, MD, ACP Member, is a practicing internist and teaching physician in Southeast Michigan. The blog, which has been around in various forms since 2007, offers musings on the intersection of science, medicine, and culture.

Why is American Health Care So Expensive?
Janice Boughton, MD, FACP, practiced internal medicine for 20 years before adopting a career in hospital and primary care medicine as a locum tenens physician. She lives in Idaho when not traveling.

World's Best Site
Daniel Ginsberg, MD, FACP, is an internal medicine physician who has avidly applied computers to medicine since 1986, when he first wrote medically oriented computer programs. He is in practice in Tacoma, Washington.

Other blogs of note:

American Journal of Medicine
Also known as the Green Journal, the American Journal of Medicine publishes original clinical articles of interest to physicians in internal medicine and its subspecialities, both in academia and community-based practice.

Clinical Correlations
A collaborative medical blog started by Neil Shapiro, MD, ACP Member, associate program director at New York University Medical Center's internal medicine residency program. Faculty, residents and students contribute case studies, mystery quizzes, news, commentary and more.

Interact MD
Michael Benjamin, MD, ACP member, doesn't accept industry money so he can create an independent, clinician-reviewed space on the Internet for physicians to report and comment on the medical news of the day.

PLoS Blog
The Public Library of Science's open access materials include a blog.

White Coat Rants
One of the most popular anonymous blogs written by an emergency room physician.

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