Tuesday, August 4, 2015

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This is the Notice verbatim I received.

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Wednesday, July 8, 2015

Prebiotics, Probiotics, and Health Scams

I will be adding to this post.

"Claim chill: EFSA rejects probiotics for immunity, defecation", with links to the opinions, @NutraEurope 

E.g. From the article above 
"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, color and bolding added by me
"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"

"The Human Microbiome and Media Confusion", @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." They already have been! Bottom line "Though popular articles may describe some of the particulars and vagaries of the research, they seriously misrepresent the correlations and data by presenting preliminary evidence as something close to proven fact."

"Health Fraud Scams"
Includes a great short video on typical quackery marketing red flags: "a miracle", testimonials (often recruited from friends and or family), 0 reputable evidence to substantiate claims, questionable or no health credentials - all of which I have also observed in quackery promotion and advertising. 

If and when pre/probiotics are proven beneficial for health above and beyond a balanced diet, components/constituents will be regulated and standardized. 
The raw forms of all plants are subject to variations from: storage, species, crop year, and more. And there can be side effects and interactions from other components/constituents when using quantities medicinally, that are not normally used in food.
EFSA (European Food Safety Authority) approval of bowel health claim for inulin product from chicory  
EFSA approval of "reduction of post-prandial glycaemic responses" health claim for inulin product from chicory 

Studies - the research is ongoing.
"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, the quality of the evidence was low or very low."

"The propre-save study: effects of probiotics and prebiotics alone or combined on necrotizing enterocolitis in very low birth weight infants." 
"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." kidshealth.org/parent/medical

"Can probiotics shorten the duration of the common cold? | American Pharmacists Association", @pharmacists
"a specific recommendation and product are not yet available." 

"Probiotics: just a waste of your money?", bolding added by me, @MailOnline
"According to the European Food Safety Authority (EFSA), so far the evidence just isn’t there yet ... EFSA ... rejected all the health claims for probiotics submitted since 2009"

The abstract of the study mentioned at the end of the above article
"Randomised clinical trial: a liquid multi-strain probiotic vs. placebo in the irritable bowel syndrome – a 12 week double-blind study"
"results suggest this probiotic confers benefit in IBS and deserves further investigation"
Bottom line - unproven - more research is needed!

"Notes from the Field: Fatal Gastrointestinal Mucormycosis in a Premature Infant Associated with a Contaminated Dietary Supplement — Connecticut, 2014", bolding added by me, @CDCgov
"Dietary supplements thought to have probiotic effects ... although there are concerns that the safety of the products has not been adequately documented

"Questions and Answers on Dietary Supplements", FDA, color and bolding addd by me, @US_FDA

"responsibility for ensuring that a dietary supplement is safe?
By law ... manufacturer ... responsible ... before they are marketed." 

Preliminary research - UNPROVEN. The EFSA is right! "the evidence just isn’t there yet". Company safety is paramount! Bottom line regarding quack safety - ALL supplements/products -THEY DON'T CARE - they shill them for your money, and their ego! Harm? They make excuses, and blame the FDA and you!

Thursday, July 2, 2015

Rose Water and Rose Products

I will be adding to this post.

I was asked to research rose water because a company is selling it as a drink with what the inquirer considers to be some very questionable claims. I agree! 


"Results showed that the essential oils of these accessions had considerable variabilities for major and minor components."


"A preliminary study on some potential toxic effects of Rosa damascena Mill", a study on dogs, bolding added by me 
"Recent studies suggest a wide variety of therapeutic effects for R. damascena ... little is known regarding potential toxic effects of this herbal medicine ... results suggest minimal nephrotoxic or hepatotoxic effects for the infusion of R. damascena ... however, the medication may be hepatotoxic at extraordinary high doses ... Further research is needed to identify the potentially toxic ingredients" 
Interesting and honest


Bulgarian rose oil aka Rosa damascena oil "Contact dermatitis from geraniol in Bulgarian rose oil", color added by me
In this case report, the researchers state they were not able to find "any previous case reports of sensitivity to this essential oil, obtained from the Bulgarian rose of the damask family." That does not mean such sensitivity is not possible as you will see as this blog post unfolds.  


"Allergic contact dermatitis following exposure to essential oils.", full text, color added by me
"Keywords: Bulgarian rose oil; hand dermatitis; lavender oil; natural therapist; occupational skin disease; ylang ylang oil ... Allergic contact dermatitis from the topical use of essential oils is not widely recognized as an occupational hazard. Four cases of allergic contact dermatitis to essential oils occurring in three aromatherapists and one chemist with a particular interest in aromatherapy are described ... Case 2 exhibited
sensitivity to geraniol" And from "Table 1 Results of patch tests" all 4 Cases tested positive (sensitivity) to Bulgarian rose oil. 

"Allergic Contact Dermatitis to Cosmetics", color added by me
"In our series, we found 55 positive patch test results to perfumes ... 33 fragrances that caused sensitization from the specific series were geraniol (7 cases), hydroxycitronellal (4 cases) ... oak moss absolute (2 cases), eugenol (2 cases), Bulgarian rose oil (2 cases)

"Your patch testing results indicate that you have a contact allergy to ROSA DAMASCENA EXTRACT ... important that you familiarize yourself with this chemical and take steps to avoid coming in contact with it ... can be identified by different names, including: Absolute bulgarian, Rose Oil, Rose De Mai oil, Attar of Rose, Rose oil, Bulgarian, Rose leaf oil ... This may not be a complete list as manufacturers introduce and delete chemicals from their product lines." 

Updated 2015

"Fragrance mix allergy", color added by me
"Fragrance mix is a mixture of 8 individual fragrances that is used to screen for fragrance allergy. The 8 listed are the most common allergy-causing fragrances that are used across many products for their fragrant and flavouring properties ... Geraniol ... Sweet floral odour of rose ... Constitutes a large portion of rose and palmarose oil, geranium oil, lavender oil, jasmine oil and citronella oil ... Present in over 250 essential oils"  


"Assessment report on Rosa gallica L., Rosa centifolia L., Rosa damascena Mill., flos", bolding added by me
"In conclusion, traditional herbal medicinal products containing Rose flower ... can be registered in the following indications: 1) Traditional herbal medicinal product ... mild inflammations of the oral and pharyngeal mucosa ... 2) relief of minor skin inflammation ... in the absence of sufficient data ... use is intended only in adolescents, adults and elderly ... not recommended during pregnancy and lactation ... no available data on genotoxicity, carcinogenicity, reproductive and developmental toxicity on Rose flower" See also "The indications adopted by HMPC" "The use in children under 12 years of age is not recommended."

A problem in identifying a reaction to a product or ingredient can be labeling, which can have different names for identical ingredients. A significant problem is company, quack use of preliminary animal, questionable human studies to make false or misleading claims, with no cautions. 

Dose makes the poison. The amount of something normally used in food is not the same as that used medicinally, or as a replacement for other fluids to ingest. 


"Contact Dermatitis: A Practice Parameter - Update 2015", bolding added by me, @AAAAI_org
"These parameters are not designed for use by the pharmaceutical industry in drug development or promotion ... Botanicals” (such as tea tree oil, propolis, and other essential oils) are plant extracts ... increasingly used as additives to skin care products and are potential causes of CD. It is important that patients who are allergic to fragrance also be made aware of the potential dangers of cosmetic products that may contain plant extracts and patients should also be counseled that “natural products” does not equate with safety."


"Allergic Contact Dermatitis to Plant Extracts in Cosmetics", bolding added by me 
"Specific botanicals implicated in causing cosmetic contact dermatitis include ... tea tree oil, peppermint, lavender, lichens, henna ... many plant extracts ... reported to cause allergic contact dermatitis through cosmetic use in one or a limited number of reports. These include Aloe vera ... Azadirachta indica oil (neem oil) ... Curcuma longa (tumeric) ... Glycyrrhiza glabra (licorice) ... Hamamelis virginiana (witch hazel) ... Olea europaea oil (olive oil) ... Ricinus communis oil (castor oil plant) ... Rosmarinus officinalis (rosemary) ... Simmondsia chinensis (jojoba) ... Thymus vulgaris (thyme)" 


"Occupational Acute Anaphylactic Reaction to Assault by Perfume Spray in the Face", bolding added by me
"no history of rashes, wheezing, allergies, or reactions to fragrances, soaps, or perfumes, and there was no history of asthma or eczema ... anaphylactic reaction and respiratory distress as a result of a deliberate assault with a perfume spray ... many organic compounds present in perfumes have been documented to cause or exacerbate asthma, eczema, or dermatitis. This case represents an incident of acute asthmatic symptoms in a person with pollen allergies when exposed to a large amount of perfume

Saturday, June 6, 2015

Fraud and Law

I will be adding to this post. 

Bolding of text by me.


"Fraud crime is a personal violation."

"Fraud victims should be aware that the issue of their alleged contributory negligence has been addressed by the courts ... the Supreme Court of Canada held that, with respect to torts of strict liability, such as conversion (theft), the claim itself “militates against the defence of contributory negligence”. ... more plainly, a fraud victim’s lack of due diligence or reckless investing is not a defence available to some who made intentional fraudulent misrepresentations to obtain a fraud victim’s money. ... a fraud victim’s lack of due diligence is not a defence to a fraudster who steals by lies."


"Seller of “Miracle Mineral Solution” Convicted for Marketing Toxic Chemical as a Miracle Cure
"Louis Daniel Smith, 45, was convicted ... of conspiracy, smuggling, selling misbranded drugs and defrauding the United States. Evidence at trial showed that Smith operated a business called “Project GreenLife” (PGL) from 2007 to 2011.  PGL sold a product called “Miracle Mineral Supplement,” or MMS, over the Internet. ... “This verdict demonstrates that the Department of Justice will prosecute those who sell dangerous chemicals as miracle cures to sick people and their desperate loved ones,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer of the Justice Department’s Civil Division." 

Wednesday, May 6, 2015

Cruelty-free Cosmetics

I will be adding to this post.

"The truth about animal research labels.", 2015, @thestarfishca
"these labels mean rather little, both in the U.S. and in Canada. Companies can say “Not Tested on Animals”, even if they actually do. There is no legal definition for animal research claims. Often, this means that the final cosmetic product is not tested on animals, but the individual ingredients are. Other types of labels ... have some meaning granted by a third party organization, but they do not guarantee that no animal testing was done in the creation of the hand soap, face wash, or body lotion."

"Questions and Answers: Animal testing and cosmetics", 2013, updated 2015, Europe

"With the full ban in place – can consumers be sure that cosmetics and cosmetic ingredients purchased in Europe were not subject to animal testing?
With the testing and marketing ban in force there can be no new animal testing for cosmetics purposes in the Union – be it for cosmetics products or ingredients thereof - and it is no longer possible to simply carry out testing for these purposes outside the Union and then use the data here to substantiate the safety of cosmetics. Consumers can therefore be sure that the cosmetic use of an ingredient in Europe cannot be the reason for any new animal testing.
However, the majority of ingredients that go into cosmetics are ingredients that are also in use in many other consumer and industrial products, such as in pharmaceuticals, detergents, food ... They may therefore be subject to animal testing requirements under these respective legal frameworks."
Translation - no guarantee. And Note: The ban only applies to new animal testing for cosmetics, not prior testing.

Friday, April 17, 2015


I will be adding to this post.

To me, it is just as important when debunking quack claims, to offer people reputable sources, for reputable information.

Celiac/coeliac is not a modern disease - and that's been known for a very long time!

"A history of coeliac disease.", 2008
"Coeliac disease may have an ancient history dating back to the 1st and 2nd centuries AD. The first clear description was given by Samuel Gee in 1888."

"New Study Finds that Many Probiotics Are Contaminated with Traces of Gluten", 2015, color and bolding added by me

"these findings raise troubling questions ...“Why is there any gluten in these products? Why should the consumer pay any attention to gluten-free labeling on such products? ... will regulatory bodies take action to protect the public?”"

"Many Probiotics Contain Traces of Gluten, Study Says", 2015, color and bolding added by me

"Dr. Peter Green, professor of medicine and director of the Celiac Disease Center. “We found previously that about 25% of celiac patients use supplements or non-traditional medical products ... people [who used probiotics] had more symptoms compared to people who weren’t taking these supplements”"

"Should Your Children Avoid Gluten?", 2013, @nationwidekids
"gluten free diet does have potential deficiencies including fiber, calcium and other vitamins and minerals ... If your child is having any symptoms that make you suspicious that he or she may have celiac disease ... important to talk with your pediatrician. If your pediatrician has your child tested and it is it found that they have celiac disease, or if they think your child would benefit from a gluten free diet, work with him or her to find alternative sources of these nutrients to supplement their diets."
Author information

"7 Myths and Facts about Celiac Disease", 2014
" Myth 5: Kids with celiac disease have to use gluten free soap, shampoo and lotion.
Fact: Gluten cannot be absorbed through the skin, but parents need to be aware of hygiene products that are easily ingestible, especially when bathing younger children." 

"Think You’re Sensitive to Gluten? Think Again", 2015, bolding added by me
"86 percent of individuals who believed they were gluten sensitive could tolerate it"
The study discussed above
"Non-Celiac Gluten Sensitivity among Patients Perceiving Gluten-Related Symptoms.", 2015
"Eighty six percent of patients reporting gluten-related symptoms have neither NCGS, nor CD, nor WA. Self-perceived gluten-related symptoms are rarely indicative of the presence of NCGS"

"Obsessive-Compulsive Disorder (OCD): Causes, Symptoms and Treatments", 2015, @mnt
"exact cause has not been identified"

"CELIAC DISEASE AND MENTAL HEALTH: ANXIETY", 2015, bolding added by me @CeliacAwareness   

"researchers are beginning to recognize ... association between celiac disease and anxiety, more research is needed to fully understand the relationship between these two conditions."

"Factors linked to development of celiac disease identified", 2015, color and bolding added by me
"celiac disease in children is significantly associated with sex of the child, maternal celiac disease, and type 1 diabetes "

"Cosmetic Labelling Regulations", 2013
"To date, we have been unable to find any toothpaste that contains gluten."

"Action Alert: Notifying the FDA about Misbranded Gluten-Free Products" | Gluten Free Watchdog, 2014 https://www.glutenfreewatchdog.org/blog/Action-Alert-Notifying-the-FDA-about-Misbranded-Gluten-Free-Products/37
"Foods Labeled Gluten-Free Must Now be in Compliance with the FDA Gluten-Free Labeling Rule" | Gluten Free Watchdog, 2014

"Gluten and Food Labeling: FDA's Regulation of 'Gluten-Free' Claims" updated, 2015

"Are gluten-free standards too strict for manufacturers?" | Food Magazine:, 2014, bolding added by me

"Thirty years ago ... threshold sensitivity for gluten testing ... as high as 200ppm ...Ten years that ... dropped to 30ppm. Five years ago it ,,, dropped to 10ppm. Nowadays it’s around 3ppm ... Australian analytical laboratories are looking at new test methods that are around 10 times more sensitive ... Improvements in gluten detection means that a food which was gluten-free five years ago may not be gluten-free today, and a food that is gluten-free today may not be gluten-free next year."

"Gluten-Free Certification Organization (GFCO)", 2015, color added by me

"Does gluten-free certification guarantee that a product is gluten-free? ...
mark assures that the finished product contains 10-ppm or less gluten ... No testing method is available that measures to zero."

Any cosmetics company that claims "tested 100% gluten-free" products is not being accurate since such testing doesn't exist yet!

Any cosmetics company that uses scare tactics, and or misleading, confusing labeling to sell their products is to me, disreputable period!

"What Is Gluten-Free? Foods With Gluten-Free Label Still May Contain Some Gluten", 2014, bolding added by me

"Current testing technology can detect gluten down to about 3ppm ... some specialty manufacturers produce products with less than 5ppm of gluten in them ... if you're sensitive to lower levels of gluten, you may react to products tested to have less than 5ppm of gluten in them."

"Gluten-free skin and beauty products: Extracting cash from the gullible", 2014, @ScienceBasedMed
"overblown claims for “going gluten-free,” and ridiculous products such as gluten-free skin care products"

Therein lies the "rub" (quandary) to quote Shakespeare. If a cosmetics manufacturer is claiming gluten-free for certain products, can that claim be trusted?
If said cosmetics manufacturer, or anyone promoting them also makes outrageous (health fraud), or drug claims with no proven evidence for those claims, most probably not. They don't have credibility. If you have celiac disease, or young children who do, it is best not to take a risk with such a company for any products needed. Consult with your medically qualified specialist for recommendations.
See also
http://www.fda.gov/forconsumers/consumerupdates/ucm439270.htm, 2015