Introduction

Crohn’s disease is a zoonotic immune-mediated disease which is the product of two separate immune system interactions involving Mycobacterium Avium Subspecies Paratuberculosis (MAP). Confronted by MAP infectious challenge, in arresting continued mycobacterium replication, the baby’s inherent immunity may become so stressed that its pro-inflammatory response to MAP becomes fixed within immunological memory. Whenever re-challenged by MAP’s presence in milk-based commercial products, the immune system responds by again unleashing a Th1 immune response against MAP at its site of mucosal attachment rather than exhibiting immunological tolerance. Dealing with MAP as an infectious agent, a baby’s inherent immunity may become so stressed in arresting continued mycobacterium replication that its pro-inflammatory response to MAP becomes fixed within immunological memory. Whenever re-challenged by MAP’s presence in milk-based commercial products, the immune system always responds by unleashing Th1 cytokines against MAP at its site of mucosal attachment. The requisite for disease is repetitive and concentrated to MAP and its antigenic array interaction with anti-MAP directed cytokines in order to overwhelm the regenerative capacity of the small bowel gastrointestinal mucosa. The current pathogenesis of CD has answered all of the key epidemiological facts embedded in CD’s natural history: Why breast feeding confers protection against the future development of CD, why CD is a new disease, why CD has attained global epidemic status only in industrialized nations, why the ileocecum is the site of initial disease and why MAP infection must become prevalent in the milking herds before CD manifests in the general population.

Clinical Diseases

Understanding the pathogenesis of Crohn’s disease provided an explanation for one of the more perplexing facets of the natural history of Crohn’s disease, the ability of breast feeding of babies to confer relative immunity against the subsequent development of Crohn’s disease. The transformation of a once rare disease entity into its current status as a global epidemic among industrialized nations required that MAP infection of the newborn be established in the relative absence of acquired immunity. In 2005, investigators at the veterinary research institute in the Czech Republic first demonstrated that 49% of 51 brands of infant formula manufactured in seven different countries by 10 different producers contained MAP DNA.Their initial findings were fully confirmed. If administered in the immediate newborn period, adulterated infant formula/powdered milk constituted a delivery vehicle by which the bovine pathogen, MAP, could infect a baby at a time of immune system compromise.

Induction of the dysfunctional pro-inflammatory with MAP at its sites of gastrointestinal mucosa attachment does not translated into clinical disease without repeated and concentrated antigen challenges overran extended period of time. The importance of MAP challenge is demonstrated by the simple elimination from diet all milk and milk-based products and meats derived from grass-eating animal’s results in significant amelioration provided that underlying infection is not in place. In clinical trials of dietary manipulation, Sigall-Bonehet et al. achieved clinical remissions in 70% of individuals with CD using exclusion diets. Chiba et al. reported that 94% of Crohn’s afflicted individuals who remained on a semi-vegetarian diet maintained their clinical remission whereas 33% who returned to a regular diet relapsed. In rare instances, permanent remissions have been achieved by rigid adherence to a vegetarian diet.

The acute focus and controversy on therapy has overshadowed disease prevention. The protective effect of breastfeeding based upon retrospective epidemiological data is validated by concomitant comparative studies. Before the introduction of western food, Canadian Indians, Maoris in New Zealand, Arab residents in Israel and Roma populations all documented the protective effect of breastfeeding. The Czech Republic Roma population data contained a key control subpopulation. Breastfeeding is culture-based among Roma (gypsy) women. Roma women were much slower to adopt change. The rate of CD among Roma has persistently been half the incidence of the other Czech population.

If breastfeeding is protective and the reasons why it is protective are in evidence, the questions posed are why aren’t warnings on product labels or at very least, why aren’t mothers given the information needed to make an informed decision concerning newborn nutrition for the first four weeks of life and why isn’t breastfeeding aggressively promoted given USDA’s demonstrated inability to limit MAP spread among milk-producing animals?

The documented, significant possibility of a viable bovine pathogen being in infant formula and powdered milk and scientific evidence incriminating it etiologically in the CD pandemic should have created a dilemma for governmental agencies. Food Safety is addressed by standing legislation. The federal meat inspection act (21 U.S.C. 601 et seq.), the poultry protection act (21m U.S.C. 451 et seq.) and the federal food, drug and cosmetic act (21 U.S.C. 321 et seq.) identify a food as being adulterated if it bears or contains any deleterious substance which may render it injurious to health and is not neutralized by its subsequent processing. Under these laws, products that are adulterated cannot enter into commerce for food consumption. 

The FDA has long buttressed itself against having to label a food substance as being hazardous to the public health by requiring that the proof be both evidence-based and absolute. Restricting conclusions to evidence-based studies effectively places the documentation of new concepts primarily in the hands of those who can afford to fund evidence-based studies. With respect to adulteration of infant formula and Crohn’s disease, these policies are contrary to the Rio declaration on food safety and the world trade organization agreement principles. Principle 15 of the Rio declaration on food safety which states “Where there are threats of serious irreversible damage, lack of full knowledge shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation”. Article 5.7 of the world trade organization agreement on sanitary and phytosanitary measures allows for regulatory measures to be enacted “where scientific evidence is insufficient to demonstrate the safety of a product or commodity”.

USDA has neither demonstrated the will nor the ability to reduce MAP’s prevalence within milking herds. The only way to abort the CD global epidemic is to prevent newborns from acquiring infection MAP infection during the first four weeks of life. The need for administrative intervention is limited to the first four weeks of life. Industry’s ability to produce a non-milk-based infant formula for use in the critical period for immune system dysfunction induction would be minimal versus inflicted government and societal costs from disease. In the United States, effective FDA action to stem the ongoing Crohn's disease zoonotic epidemic could have been as limited as giving pregnant women the information necessary that allows them to make a fully informed decision as to how newborns will receive nutrition within the first four weeks of its life.

In July of 2018, the U.S. delegation to the United Nations-affiliated world health assembly stunned the world by their vigorous opposition to a pending breastfeeding resolution. The delegation demanded that the assembly remove any provision that restricted the promotion of any food products that have deleterious effects on young children and was successful in aborting the resolution that called on the World Health Organization (WHO) to provide technical support to member nations seeking to halt inappropriate promotion of infant formula. Globally, an estimate 800,000 infants died per year because of the lack of access to clean water used to reconstitute powdered milk.