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"
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm617168.htm
"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."
"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"
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm617168.htm
"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"
https://www.fsai.ie/faq/probiotic_health_claims.html
"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
https://www.dailymail.co.uk/health/article-2856661/Probiotics-just-waste-money-Health-claims-unproven-scientists-divided-benefits.html
https://www.dailymail.co.uk/health/article-2856661/Probiotics-just-waste-money-Health-claims-unproven-scientists-divided-benefits.html
"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." http://kidshealth.org/parent/medical/digestive/nec.html
"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
"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."
and
"Probiotics (live micro-organisms) to
prevent upper respiratory tract infections (URTIs) (for example,the common
cold)", 2015, color and bolding added by me
http://www.cochrane.org/CD006895/ARI_probiotics-live-micro-organisms-to-prevent-upper-respiratory-tract-infections-urtis-for-example-the-common-cold
http://www.cochrane.org/CD006895/ARI_probiotics-live-micro-organisms-to-prevent-upper-respiratory-tract-infections-urtis-for-example-the-common-cold
"probiotics may be more beneficial than placebo for preventing acute URTIs.
However ... quality of the evidence was
low or very low."
Summary
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."
Probiotic Claims", Canadian Food Inspection Agency, 2015, color and bolding added by me
http://www.inspection.gc.ca/food/labelling/food-labelling-for-industry/health-claims/eng/1392834838383/1392834887794?chap=9
"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."
Objection
"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
http://ktanihairsense.blogspot.ca/2015/04/gluten-free.html