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! 

"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). 2015, 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." 

"Probiotic Health Claims", Food Safety AUTHORITY OF IRELAND, 2015, color and bolding by me
"There are no approved health claims for probiotics. ... Applications for health claims on probiotics have been submitted for evaluation to EFSA and no application has received a positive opinion ... The European Commission has advised the FSAI that where terms like ‘live’ or ‘active’ are used to describe bacteria, these imply a probiotic function and therefore are considered to be health claims. No health claims have been approved for ‘probiotic’ and therefore terms that imply a probiotic function are not permitted."

"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

Thursday, January 7, 2016

Onion, Garlic, Ginger as Health Remedies - UNPROVEN

I will be adding to this post.

A number of anecdotal natural remedies abound on the Internet. Here is what the most current research actually says!

"Effects of Onion Juice on the Normal Flora of Eyelids and Conjunctiva in an Animal Model", 2014, color and bolding added by me

"it appears that onion juice in the form of eye drops can serve as a new antimicrobial therapy for ophthalmic diseases in future studies and our study may be a starting point for further investigations on this herb." = UNPROVEN

"Comparative in vitro anti H2O2 activity and antibacterial efficacy of garlic and immature onion bulbs against selected human gammaproteobacterial pathogens", 2015, color and bolding added by me
"It is concluded that Garlic and Onion act as an antagonist to the gammaproteobacterial pathogens studied here and if experimented on the synergistic action of both these bulbs active compounds, it might provide good results in future. The methanolic extracts showed better results because polyphenols groups are extracted with polar solvent like methanol and purity of extract is also maintained. Further investigation of individual phenolic compounds and in vivo antioxidant mechanisms are required. " = UNPROVEN

"Garlic: a review of potential therapeutic effects", 2014, color and bolding added by me

"In comparison with the antibacterial action of garlic, very little work has been done to investigate its antiviral properties. The few studies have reported that garlic extract showed in vitro activity against influenza ... There are insufficient clinical trials regarding the effects of garlic in preventing or treating the common cold. ... Although garlic is believed to be a safe substance, long-term trials of reasonable duration would provide insights into the possible side-effects of different garlic extracts. The safety of garlic should be tested especially in pregnant or breastfeeding women as well as in young children ... Long-term and large trials are also needed to evaluate the differences in mortality, serious adverse events, and morbidity of cancer and cardiovascular diseases after garlic therapy." = UNPROVEN and Note: in vitro - NOT in people! 

"Garlic Revisited: Antimicrobial Activity of Allicin-Containing Garlic Extracts against Burkholderia cepacia Complex", 2014, color and bolding added by me
"Our investigation suggests that further work is required to comprehensively describe the antimicrobial mechanisms of allicin and to assess allicin-containing formulations as adjuncts to conventional antimicrobial agents presently used against this challenging group of bacterial pathogens." = UNPROVEN

See also "Garlic", 2016, bolding added by me, @medlineplus
"Garlic can thin the blood (reduce the ability of blood to clot) in a manner similar to aspirin. ... Use garlic with caution if you are planning to have surgery or dental work, or if you have a bleeding disorder. ... Garlic has been found to interfere with the effectiveness of saquinavir, a drug used to treat HIV infection. Its effect on other drugs has not been well studied."
and this blog post

"Antimicrobial Activity of Onion and Ginger against two Food Borne Pathogens Escherichia Coli and Staphylococcus Aureus". 2015, color and bolding added by me
"Recent research conducted on the antimicrobial effect of ginger and onion showed weak to medium antibacterial properties ... Onion showed good antimicrobial properties against S.aureus ... but was not all that effective against E.coli. Ginger showed very poor antimicrobial properties against either of the organisms. ...  important to note that the experiment was affected by various factors which include concentration of spice extracts, volume of agar, and concentration of culture and incubation times. Future studies should be conducted in a more controlled environment were these factors are constant. Also future research should observe if the phytochemicals present in spices showed synergetic or antagonistic properties against each other." = UNPROVEN

"Phytochemical Screening and Invitro Antibacterial Activity of Allium Cepa Extracts Against Methicillin Resistant Staphylococcus Species", 2015, color and bolding added by me
"traditional use of onion for infectious diseases and for controlling MRS species infection appears to be justified" = UNPROVEN

Saturday, January 2, 2016

Oral Allergy Syndrome

I will be adding to this post. 

IMPORTANT information to know! DON'T be fooled by false/misleading marketing claims! 

What’s the buzz all about?", 2016, color and bolding added by me
"Whether or not a pigment is organic or inorganic will not guarantee ... results ... or how well the procedure will turn out."
"We are a non-profit association"

TRUE! It's best to do reputable research ahead of a planned tattoo, and ask questions before you wind up with a problem! 

"Oral Allergy Syndrome" - Food - Canadian Food Inspection Agency ", 2012 
"Oral allergy syndrome is an allergic reaction to certain proteins in fruit, vegetables and nuts. This condition is called "oral allergy syndrome" because it usually affects the mouth and throat." 

That also means you need to be careful about dyes that could set off life threatening allergies, know if you are at risk, whether it involves tattoos, or any other cosmetics colorants! Who best to consult with about your risk factors? Your allergist/immunologist because ...! 

"New risks from ancient food dyes: cochineal red allergy", 2014, full text, color and bolding added by me

"Although the risk of anaphylactic reactions is well known, since the nineties the use of this additive seems to be nowadays on the rise. ...This case confirms the actual risk of allergic reactions induced by Carmine red present not only in food, but also in dietary supplements and OTC drugs. Its increased use may expose the population to a relevant risk of IgE sensitization. The possible occurrence of symptoms some hours after the ingestion of the dye is reported in the literature, and may result in undiagnosed cases labelled as “idiopathic anaphylaxis”. The natural Cochineal red, classified in Europe as E120, must be distinguished from the synthetic form, the Cochineal Red A also named Ponceau 4R (E124), belonging to the azo-dyes. It is known as histamine-liberator, but not as IgE sensitizing agent. We believe that accurate, more specific and strict regulation on labelling (both at an international and national level) is crucial in safeguarding health. ... recently the FDA ruled that food, drugs and cosmetic products containing coloured additives like cochineal extracts and carminic acid must be clearly labelled. In Europe, the regulation on food labelling includes additives and dyes ... The system appears to be efficient at level of industrial products, while handmade foods are more at risk of undeclared manipulation."

Regarding the last sentence above - I have no doubt that would also apply to handmade, and crafted natural cosmetics regarding other natural dyes! It is about whether the manufacturers/marketers of these types of foods and cosmetics, who are liable are safety protocols, and otherwise - government regulations - compliant!

""Organic" Cosmetics", 2015, color and bolding added by me @US_FDA
"An ingredient’s source does not determine its safety. ... many plants, whether or not they are organically grown, contain substances that may be toxic or allergenic."

"Tattoos & Permanent Makeup: Fact Sheet" FDA, 2015, color and bolding added by me, @US_FDA

"FDA traditionally has not exercised regulatory authority for color additives on the pigments used in tattoo inks. The actual practice of tattooing is regulated by local jurisdictions. During 2003 and 2004, FDA became aware of more than 150 reports of adverse reactions in consumers to certain permanent makeup ink shades ... The inks associated with this outbreak were voluntarily recalled by the company that marketed them in 2004. ... 2012, we received reports of infections from contaminated inks, resulting in their recall and market withdrawal. In addition, concerns raised by the scientific community regarding the pigments used in tattoo inks have prompted FDA to investigate their safe use. FDA continues to evaluate the extent and severity of adverse events associated with tattooing and is conducting research on tattoo inks. As new information is assessed, we will consider whether additional actions are necessary to protect public health."

"Color Additives and Cosmetics", FDA, 2016, color and some bolding added by me, @US_FDA

"Colors exempt from certification. These color additives are obtained primarily from mineral, plant, or animal sources. They are not subject to batch certification requirements. However, they still are considered artificial colors, and when used in cosmetics or other FDA-regulated products, they must comply with the identity, specifications, uses, restrictions, and labeling requirements stated in the regulations

"FDA Authority Over Cosmetics", 2016, color and bolding by me, @US_FDA
"Companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety of their products. ... FDA is not authorized to order recalls of cosmetics, but we do monitor companies that conduct a product recall and may request a product recall if the firm is not willing to remove dangerous products from the market without FDA's written request. FDA may take regulatory action if we have reliable information indicating that a cosmetic is adulterated or misbranded. ... FDA can pursue action through the Department of Justice in the federal court system to remove adulterated and misbranded cosmetics from the market. To prevent further shipment of an adulterated or misbranded product, FDA may request a federal district court to issue a restraining order against the manufacturer or distributor of the violative cosmetic. Cosmetics that are not in compliance with the law may be subject to seizure. ... FDA can and does inspect cosmetic manufacturing facilities to assure cosmetic product safety and determine whether cosmetics are adulterated or misbranded"

E.g. of seizure
"FDA requested the seizure ... because the products claim to treat or cure diseases but have not received FDA approval, and are not exempt from such approval requirements. Moreover ... the seized products contain ingredients that could cause toxic or allergic reactions in consumers sensitive to these ingredients. ... Chickweed Healing Salve contains comfrey, which may increase the risk of systemic toxicity"