Sunday, January 17, 2016

Prebiotics, Probiotics and Health Scams

I will be adding to this post.

"The Human Microbiome and Media Confusion", 2015, color and bolding added by me, @SITNHarvard

"public impression of microbiotic research differs from the present-day reality ... serious risk that pre/probiotics will be marketed as miracle cures for a laundry list of physical and psychological ailments under a pseudo-academic purview."

Regarding the above statement - they already ARE by quacks - while research continues, and is still in the PRELIMINARY stages=UNPROVEN! 

"Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans ... August 16, 2018"
"there are FDA-regulated foods, including dietary supplements, containing probiotics that are legally available … these products cannot lawfully be marketed to cure, mitigate, treat, or prevent any diseases."

"Probiotic Health Claims"Last reviewed: 27/6/2018"
"There are no approved health claims for probiotics. … Applications for health claims … have been submitted for evaluation to EFSA ... no application has received a positive opinion. ... no claims on probiotics are listed on the EU register as authorised for use." 

"Health Fraud Scams", 2016, @US_FDA
Includes a great short video regarding FRAUD red flags and the recruiting of "testimonials" from friends and or family!

"With health claims unproven and scientists divided on the benefits: Are probiotics just a waste of your money?", 2014, color and bolding added by me, @MailOnline
"Food Safety Authority (EFSA), so far the evidence just isn’t there yet ... rejected all the health claims for probiotics since 2009."

When the EFSA DOES approve health claims, they are VERY specific.

"Scientific Opinion on the substantiation of a health claim related to “native chicory inulin” and maintenance of normal defecation by increasing stool frequency pursuant to Article 13.5 of Regulation (EC) No 1924/20061", 2015, bolding added by me
"The Panel concludes that a cause and effect relationship has been established between the consumption of “native chicory inulin”, a non-fractionated mixture of monosaccharides (< 10%), disaccharides, inulin-type fructans and inulin extracted from chicory with a mean DP ≥ 9, and maintenance of normal defecation by increasing stool frequency."

"Scientific Opinion on the substantiation of a health claim related to non-digestible carbohydrates and a reduction of post-prandial glycaemic responses pursuant to Article 13(5) of Regulation (EC) No 1924/20061", 2014, bolding added by me
"The Panel concludes ... A cause and effect relationship has been established between the consumption of foods/beverages containing non-digestible carbohydrates instead of sugars and a reduction of post-prandial glycaemic responses as compared to sugar-containing foods/beverages. ... In order to bear the claim, sugars should be replaced in foods or drinks by non-digestible carbohydrates so that foods or drinks contain reduced amounts of sugars as per Annex of Regulation (EC) No 1924/2006 and in accordance with the Guidance on the implementation of Regulation (EC) No 1924/2006 of the Standing Committee on the Food Chain and Animal Health for comparative nutrition claims made on foods"

The EFSA is EQUALLY specific on the rejection of health claims.

"Scientific Opinion on the substantiation of a health claim related to Bifidobacterium bifidum CNCM I-3426 and defence against pathogens in the upper respiratory tract pursuant to Article 13(5) of Regulation (EC) No 1924/20061", 2015, bolding added by me
"Following an application from Lallemand Health Solutions ...  the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Bifidobacterium bifidum CNCM I-3426 and defence against pathogens in the upper respiratory tract. The food constituent that is the subject of the claim is B. bifidum CNCM I-3426. ... The Panel considers that no conclusions can be drawn from either of the human studies for the scientific substantiation of the claim. In the absence of evidence of an effect of B. bifidum CNCM I3426 on defence against pathogens in the upper respiratory tract in humans, the results of the in vitro study submitted cannot be used as a source of data for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of B. bifidum CNCM I-3426 and defence against pathogens in the upper respiratory tract."

In the meantime, research is ongoing!

"Bifidobacterium breve BBG-001 in very preterm infants: a randomised controlled phase 3 trial", 2015, color and bolding added by me
"result does not support ... use of B breve BBG-001 ... prevention ... necrotising enterocolitis ... late-onset sepis in very preterm infants ... evidence from clinical trials does not support ... routine use of probiotics to prevent necrotising enterocolitis ... in the preterm infant

"The propre-save study: effects of probiotics and prebiotics alone or combined on necrotizing enterocolitis in very low birth weight infants." 2015, bolding added by me
"probiotic (Bifidobacterium lactis) and synbiotic (Bifidobacterium lactis plus inulin) but not prebiotic (inulin) alone decrease NEC."
2015 NEC "necrotizing enterocolitis ... common and serious intestinal disease among preemies."  

"Diverse gut bacteria lowers asthma risk in babies: study", 2015, color and bolding added by me, @japantimes
"it remains unclear exactly how infants acquire these particular bacteria — they are named Faecalibacterium, Lachnospira, Veillonella and Rothia — and researchers said more study is needed to find out why some babies naturally acquired them from their environments and others did not. ... co-author Stuart Turvey, a doctor at the British Columbia Children’s Hospital cautioned against seeking the answer in store-bought products"
The study
"Early infancy microbial and metabolic alterations affect risk of childhood asthma", 2015, color and bolding added by me
"These results enhance the potential for future microbe-based diagnostics and therapies, potentially in the form of probiotics, to prevent the development of asthma and other related allergic diseases in children."

"Fermented Fruits and Vegetables of Asia: A Potential Source of Probiotics", 2014, color and bolding added by me

"In Asian continent, fermented fruits and vegetables are associated with several social and cultural aspects of different races. Studies showed that fruits and vegetables may serve as a suitable carrier for probiotics. Fermented fruits and vegetables contain a diverse group of prebiotic compounds which attract and stimulate the growth of probiotics. ... The amount of food ingredients and additives in fermented foods, such as sugar, salt, and monosodium glutamate, should conform to the accepted standards established by the regulations of target markets. Mixed fermentation with high variability should be replaced by pure cultivation to achieve large-scale production. ... challenges remain, it is possible that fermented foods, handed down for many generations, will play a major role in the global food industry. Detailed studies on the microbial composition and characteristics of fermented fruits and vegetables lead to the further application."

"Can probiotics shorten the duration of the common cold?", 2014, color bolding added by me, @pharmacists
"a specific recommendation and product are not yet available."

"Probiotics (live micro-organisms) to prevent upper respiratory tract infections (URTIs) (for example,the common cold)", 2015, color and bolding added by me
"probiotics may be more beneficial than placebo for preventing acute URTIs. However ... quality of the evidence was low or very low."

The evidence for both the safety and efficacy (effectiveness) of pre/probiotics is NOT there yet!

"The Basics of Probiotics", 2016, color and bolding added by me
"Although some probiotic formulations have shown promise in research, strong scientific evidence to support the use of probiotics for most conditions is lacking. ... Studies suggest that probiotics usually have few side effects. However, the data on safety, particularly long-term safety, are limited, and the risk of serious side effects may be greater in people who have underlying health conditions."

"Health Claims
Probiotic Claims", Canadian Food Inspection Agency, 2015, color and bolding added by me
"Probiotic claims that are therapeutic in nature or that are considered "drug" claims are required to undergo a pre-market assessment by the Food Directorate of Health Canada and a regulatory amendment to the Food and Drug Regulations to allow their use. ... When making any probiotic claim, the manufacturer or importer of the product should have documentation supporting the identification, safety, viability, concentration and stability of the probiotic strain added to the food product. ... The manufacturer or importer must follow all requirements applicable to the sale of food, including those related to the use and labelling of ingredients used in novel technology in the delivery of a viable microorganism for food application."
"Probiotics: In Depth", National Center for Complementary and Integrative Health (NCCIH). 2016, color and bolding added by me, @NIH_NCCIH
"There’s preliminary evidence that some probiotics are helpful in preventing diarrhea caused by infections and antibiotics and in improving symptoms of irritable bowel syndrome, but more needs to be learned. We still don’t know which probiotics are helpful and which are not. ... In people who are generally healthy, probiotics have a good safety record. Side effects, if they occur at all, usually consist only of mild digestive symptoms such as gas. ... On the other hand, there have been reports linking probiotics to severe side effects, such as dangerous infections, in people with serious underlying medical problems. ... Even for healthy people, there are uncertainties about the safety of probiotics. Because many research studies on probiotics haven’t looked closely at safety, there isn’t enough information right now to answer some safety questions. ... Don’t replace scientifically proven treatments with unproven products and practices. Don’t use a complementary health product, such as probiotics, as a reason to postpone seeing your health care provider about any health problem. ... If you’re considering a probiotic dietary supplement, consult your health care provider first. This is especially important if you have health problems. Anyone with a serious underlying health condition should be monitored closely while taking probiotics." 

"Agency Response Letter - Objection; Lyophilized Probiotic Cultures FALN No. 006 (Docket No. 2006FL-0287)", 2015, bolding added by me, @US_FDA
"Based on its review, FDA has concluded that FALN 006 does not contain scientific evidence (including the analytical method used) that demonstrates that Nutraceutix's products (as derived by the method specified in the notification) do not contain allergenic milk protein, as required by section 403(w)(7). FALN 006 neither provides scientific evidence to determine that the products do not contain milk allergenic protein, nor does FALN 006 otherwise meet the requirements of section 403(w)(7). FDA therefore objects to FALN 006."

Safety Risks and the price paid - a baby died.

"Notes from the field", 2015, color and bolding added by me, @CDCgov
"In October 2014, a hospital in Connecticut notified CDC and the Connecticut Department of Public Health of a fatal case of gastrointestinal mucormycosis in a preterm infant. ... Local investigation revealed that the infant had received a dietary supplement, ABC Dophilus Powder, for 7 days, beginning on day 1 of life. Unopened bottles of ABC Dophilus Powder from the lot received by the infant were cultured by the hospital microbiology laboratory; the samples yielded Rhizopusspecies, a mold capable of causing mucormycosis. CDC later confirmed these isolates as Rhizopus oryzae. Immunohistochemical staining of the cecum tissue block locally and at CDC was positive for mucormycetes. Sequencing of fungal DNA recovered from the tissue block by CDC identified the fungus as Rhizopus oryzae, the same species of fungus recovered from the unopened dietary supplement. ... Dietary supplements thought to have probiotic effects have been reported to reduce the incidence of necrotizing enterocolitis and all-cause mortality in preterm infants ... although there are concerns that the safety of the products has not been adequately documented"

"Dietary Supplements", 2016, color and bolding added by me, @US_FDA
"Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations. ... FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market."

For probiotics and gluten, please also see this blog post