FDA Finds Problems at 62% of Supplement Manufactures

Consumer Labs today reported that the FDA has found 62% of the 483 dietary supplement manufacturing facilities failed their inspections in 2014.  These were for noncompliance with the current Good Manufacturing practices (cGMP) which they are required to follow. Sadly they only inspected a small number of the total number of manufactures.

The FDA reported an average of 6 infractions per facility. The most common infractions were:

  • Not conducting at least one appropriate test or examination to verify the identity of a dietary ingredients and/or
  • Not establishing product specifications for the identity, purity, strength, and/or composition of the finished dietary supplement.

The list of results by manufactures inspected can be found on the ConsumerLabs.com website. This site requires a member sign in.  I am a member and reviewed the list and there are some big names that received letters. There are challenges though, with seeing if your favorite company was inspected and how they did for several reasons:

  • Most retailers and distributors don’t manufacture their own products. They outsource the manufacturing to contract manufactures who actually produce the product for a number of different companies.  So you buy Brand X, but Brand X doesn’t have a manufacturing facility because they contract with Company Z to do the manufacturing. The inspection would be of Company Z, not the brand you buy.
  • There are a very few manufactures of dietary supplements, such as the one I use and recommend, who are registered with the FDA as pharmaceutical drug manufactures and must adhere to much more stringent pharmaceutical Good Manufacturing Practices. So this company would fall into a different category of FDA inspections.
  • Only a small percentage of the total number of manufacturing facilities were inspected. So if your favorite company isn’t listed it isn’t because they passed or failed, but just weren’t inspected this year.

So what do you do?

  • Figure than when you look at the vitamin aisle at the health food store that over half the bottles on the shelf came from manufactures who failed their inspection.
  • Look to 3rd parties for validation of your brand. Some good sources are:
    • ConsumerLabs.com. This is a membership site but they routinely examine and test a number of different products each month.
    • NSF.org  Is the public health and safety organization. NSF certifies facilites  and also lists products they’ve approved Safe for Sport – they they insure don’t have any unlisted contaminants.
    • PDR.net – This is the Physicans Desk Reference for pharmaceutical drugs.  There are a few high quality supplement brands who are listed in this reference.  If it is listed in the PDR, your doctor knows it is safe and high quality.
    • Comparative guide to Nutritional Supplements – This publication has ranked over 1,600 different products on a 0-5 scale. The initial rating is based on the label, so no testing. But for those who were rated a 5, then they are invited to have 3rd party labs verify their products and they must have their manufacturing facilities tested as well.

The brand I use has passed all the above tests and has been the #1 ranked product in the Comparative Guide to Nutritional Supplements in all 5 editions.  Ask me and I’ll tell you who they are.

 

 

 

FDA Finally Classifies Formaldehyde as a Carcinogen.

Formaldehyde is best known as embalming fluid but it is found in many household products including your hair care, skin care, and body care products!  It is also found in pressed wood products like particle board. When you walk into a new house under construction that new house smell is formaldehyde. 


The FDA just recently added formaldehyde to its list of chemicals known to cause cancer, not that might cause cancer, but does cause cancer. Here is the report from the Department of Health and Human Services  http://ntp.niehs.nih.gov/go/roc12


When you look at products you put on your skin you won’t see formaldehyde listed as an ingredient because nobody would buy a product with that listed, but there are a number of common chemicals which degrade and breakdown fairly readily and when they break down they release formaldehyde. The most popular chemicals are:

  • Quaternium 15
  • 2-bromo-2nitropropane-1,3-dio
  • Diazolidinyl urea
  • Imidazolidinyl urea
  • DMDM Hydantoin
If you see these listed on the label, then you’re exposing formaldehyde directly to your skin daily. 

The skin care product we use and recommend is free from all formaldehyde releasing agents as well as parabens. It also doesn’t use irritating natural oils, like tea tree, grapefruit oil, etc. These aren’t harmful, but they are irritating to the skin.  I won’t mention product names here, but email me at my address below and I’ll give you information where you can find this product.
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Aspartame alert: Diet soda destroys kidney function

(NaturalNews) Scientists from Brigham and Women’s Hospital in Boston have revealed results from a study outlining some of the effects of artificial sweeteners on the body. Conducted on a group of 3,000 women, the results indicated that those who drank two or more artificially-sweetened beverages a day doubled their risk of more-rapid-than-normal kidney function decline.

The study accounted for various other risk factors including the woman’s age, her blood pressure, if she smoked, and if she had any other pre-existing conditions such as heart disease or diabetes. The 11-year study evaluated the effects of all sweetened drinks on progressive kidney decline and discovered that two or more diet drinks leads to a two-fold increase in rapid kidney decline incidences.

Though study results did not show any correlation between sugar- or corn syrup-sweetened drinks and the onset of rapid kidney decline, these ingredients are implicated in causing diabetes and obesity and should not be perceived as safe merely because they did not have a direct correlation in this particular study topic.

High sodium intake was also implicated in the study as promoting progressive kidney decline. Since diet soda contains excessive amounts of sodium, higher than sugar soda, it is no surprise that diet sodas were the primary offenders in the study. However it is unclear from this particular study which ingredient plays the larger role in progressive kidney decline, the artificial sweeteners or the sodium content.

Studies on aspartame

When aspartame was first approved in the 1970s under the name “NutraSweet”, studies were submitted as supposed proof that the artificial chemical was safe. The FDA initially approved the chemical in 1974 for use in a limited number of foods based upon the studies submitted by G.D. Searle Co., the company that invented aspartame.

Following a discovery made shortly thereafter by a research psychiatrist who found that aspartic acid, a primary ingredient in aspartame, caused holes to form in the brains of mice, the FDA decided to form its own internal task force to investigate the initial claims made by the Searle Co.

What the agency discovered was a series of falsified claims, compromised study results, and missing information. The claims made in favor of aspartame were so dubious and the evidence so faulty that the FDA decreed that a grand jury should investigate Searle Co.’s claims. Unfortunately, the case failed to move forward when U.S. Attorney Thomas Sullivan and Assistant U.S. Attorney William Conlon failed to initiate any legal action. Conlon was later hired by the law firm that represented Searle Co.

Investigation revealed that aspartame had caused tumors, seizures, brain holes, and death in many of the studies. All negative findings had been altered or scrubbed from the final reports delivered to the FDA when aspartame was first reviewed.

Time and time again the question over whether aspartame is safe has led to investigations that never go anywhere. Studies are continually released in support of the chemical’s safety even though they fail to address the results of other studies that show it to be harmful.

Other artificial sweeteners

A study published in the January, 2008 issue of the Journal of Toxicology and Environmental Health revealed that the newer artificial sweetener, sucralose, alters gut microflora and inhibits the assimilation of dietary nutrients.

Commonly marketed as being “made from sugar”, sucralose had undergone no long-term human studies to verify its safety in humans. Like aspartame, initial studies revealed negative reactions by lab animals on whom it was tested, indicating that there could be the same potential problems in humans.

The EU Food Commission, Canadian health officials, and the U.S. FDA all rejected the initial studies submitted by McNeil Nutritionals, the marketers of sucralose, because of the negative results. However they encouraged the company to continue researching until they “got it right”. McNeil simply lowered the levels of sucralose used in their studies until an acceptable limit was found. After several tries, sucralose was finally approved.

Stevia, a safe alternative

A great many varieties of artificial sweeteners have been approved, many scandalously, despite the fact that safe, natural alternatives exist. Stevia, for instance, is a sweet herb from South America that is up to 300 times sweeter than sugar. Claiming inadequate safety research, the FDA has long refused the herb from being included on the “generally recognized as safe” (GRAS) list.

Up until last year, all forms of stevia could only be sold as dietary supplements. The extract could not be labeled as a “sweetener” and it could not be included in any food items.

Once the parent companies of both Pepsi and Coca-Cola discovered how to manipulate and patent a segment of stevia, however, it suddenly became safe to use as a sweetener and is now sold on grocery store shelves in packets similar to the artificial sweeteners. The FDA reluctantly added the natural stevia extract to the GRAS list as well.

Stick with natural and unprocessed
When it comes to health, a person’s best bet is to avoid artificial sweeteners altogether. There are plenty of preferable, safe alternatives such as stevia which will allow for a little extra sweetness without all the harmful side effects.

Sources for this story include

http://www.dailymail.co.uk/health/a…

http://www.upi.com/Health_News/2009…

http://www.holisticmed.com/aspartame/

http://www.informaworld.com/smpp/co…

http://www.naturalnews.com

What? FDA Deems Mercury Level in Fillings Safe

The NY Times ran this story today along with many other news outlets:

Silver dental fillings containing mercury are safe for use by adults and children ages 6 and above, the Food and Drug Administration said Tuesday. Only people who are allergic to mercury should avoid that type of filling, the agency said.

After reviewing more than 200 scientific studies, the agency concluded that mercury vapor released by the filling was not enough to cause brain damage. Still, the agency for the first time classified the fillings as a Class II, or “moderate risk,” medical device.
Read the whole story here: http://www.nytimes.com/2009/07/29/health/29fda.html

This is insane! Mercury is one of the most toxic substances known to man and no amount is safe! Watch this short video to see very clearly how mercury or “Silver” fillings emit large amounts of mercury vapor which is readily absorbed into your body and has been linked to Alzheimer.

This is the FDA bowing to the pressure of the American Dental Association. If the FDA were to conclude that mercury were dangerous and ban mercury amalgam fillings and the link to Alzheimers and other diseases the ADA would be liable for billions and billions of dollars due to all the harm done by these fillings.

It can contribute to major chronic degenerative diseases including heart disease, multiple sclerosis, Alzheimer’s, Parkinson’s, autism, chronic fatigue syndrome, kidney disease, and other neurological diseases, just to name a few.

For more information please refer to these websites:

http://www.iaomt.org/
Dr. Wentz – Author of “A Mouth Full of Poison”