Adult Multivitamin Gummies Recalled After Company Fails to Complete Testing for Salmonella and Staph

Nature Made is recalling their Gummies Adult Multivitamins after they found that Salmonella and Staphylococcus testing was not properly completed on the batches those batches recalled.

It is hard to know the risk of these products without knowing the test results the company had found on a historical basis.  One would guess minimal.

FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm505706.htm
FDA Recall Notice
Nature Made® Recalls Various Products Because of Possible Health Risk
For Immediate Release
June 8, 2016

Dietary Tea Product Recalled After Ingredient Tested Positive for Salmonella

An Arizona company is recalling its dietary powdered tea product after notification was received from their ingredient supplier of organic spinach powder had tested positive for Salmonella.

No illnesses have been reported.

So why is there spinach powder in tea? 


FDA Recall Notice
http://www.fda.gov/Safety/Recalls/ucm490472.htm
Awareness Voluntary Recalls Boost Tea Due To Possible Salmonella Contamination
For Immediate Release
March 11, 2016

Contact
Consumers - Awareness Corp.  (480) 615-3530 X556

Awareness Corp. of Mesa, AZ, is recalling its 7.4 ounce container of Boost Tea because it may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream area and producing more severe illnesses such as arterial infections, endocarditis and arthritis.

Feds Take Enforcement Action Against Unlawful Supplement Manufacturers

 The US Justice Department along with other Federal Departments announced that they are filing cases against a number of supplement manufacturers that "make health or disease treatment claims that are unsupported by adequate scientific evidence".  

It is about time.  There are too many of these modern day snake oil salesmen who are taking advantage of people's wanting to find that secret cure / silver bullet answer to their medical woes.  Not only are claims false, but in some cases, these drugs can be dangerous.

If you had to bet, there are more out there.  While these are probably the worst of the worst, others will continue to sell products that provide little or no benefit to consumers.

 

Department of Justice - News Release

http://www.justice.gov/opa/pr/justice-department-and-federal-partners-announce-enforcement-actions-dietary-supplement-cases

 

FOR IMMEDIATE RELEASE

Tuesday, November 17, 2015

Justice Department and Federal Partners Announce Enforcement Actions of Dietary Supplement Cases

  

Criminal Charges Brought against Bestselling Supplement Manufacturer

 

As part of a nationwide sweep, the Department of Justice and its federal partners have pursued civil and criminal cases against more than 100 makers and marketers of dietary supplements. The actions discussed today resulted from a year-long effort, beginning in November 2014, to focus enforcement resources in an area of the dietary supplement market that is causing increasing concern among health officials nationwide. In each case, the department or one of its federal partners allege the sale of supplements that contain ingredients other than those listed on the product label or the sale of products that make health or disease treatment claims that are unsupported by adequate scientific evidence.

 

Man Sentenced to 51 Months for Sales Scam - Industrial Bleach as a Miracle Drink

A Washington man was sentenced to 51 months in prison for selling an industrial chemical as  Medical Miracle Solution, MMS.  The solution, as detailed by the authorities, was sodium chlorite.  According to reports, the directions had the consumer add citric acid to this which creates chlorine dioxide, a very strong oxidizing solution.  This type of mixture is used in a number of industrial applications including use as a sanitizing solution for food contact surfaces.  But not for direct consumption.  A number of people had reported becoming ill.

Consumers Warned About Dangerous Dietary Supplements

A NY dietary supplement company is recalling their supplements because they have unacceptable levels of mercury and lead.  Yikes....they are so bad that FDA advices consumers who are using them to consult a medical health provider.

Dietary supplements sales are driven by people searching for the secret passage to healthy living through a pill or drink.  Surely they think that there is something not in their normal diet and with the dietary supplement, it is going to make the individual feel better, look better, and live forever.  Some providers of dietary supplements prey on these aspirations by concocting various potions with unique live enhancing qualities and then market them by  having that unique story....that these were used by the ancients...or as in this case, the company Baidyanath connecting to Ayurveda, traditional Hindu medicine.  Okay, maybe these traditional Hindu medical doctors had something going on that was great, but hopefully, high mercury and lead content in the medicines were not part of it. 

Along with this recall, we have an Iowa company, Iowa Select Herbs, who was court ordered to recall a boatload of product made since the start of the year. 

Unfortunately, these dietary supplemtn providers have takes advantage of an under regulated industry - whether it is terms of over-the-top health claims, product that was improperly prepared, or formulations that are dangerous.   While some of these providers are nothing more than modern day snake oil salesmen, others go into the business believing that they are doing good, but do not have the necessary level of technical knowledge or capabilities.  Unfortunately for consumers, it can be difficult to determine which product is going to have dangerous levels of mercury or lead. It is good to see the increased regulatory scrutiny.

FDA Consumer Advisory
FDA Consumer Advice on Shree Baidyanath Brand Ayurveda Dietary Supplements
September 17, 2015
What you need to know

Consumers who have used any of the Baidyanath brand Ayurvedic dietary supplements listed below should stop using them and consult their health care provider.

Testing by the New York Department of Health and the U.S. Food and Drug Administration has found that these products contain high levels of lead and/or mercury, which can cause serious health problems.

The products are manufactured by Shree Baidyanath Ayurved Bhawan in India and sold in the United States at retail and via the Internet. One major retailer has recalled the products. The FDA is working to identify other companies that may have sold the products.

Herbal Supplements Questioned: Fighting Bad Practices with Bad Science?

This past week, the NY Attorney General accused major retailers (Walmart, Target, Walgreens and GNC) of selling herbal supplements that do not contain the herbs claimed on the label and issued a cease-and-desist letter demanding they stop selling those products.

Testing of the supplements was conducted using DNA barcoding, a technique that uses specific DNA sequences  to look for markers that indicate a specific plant species.  This technique has had much success in determining  animal and plant material authenticity and inclusion of potential adulterants.

However, these techniques work best on material where the DNA is likely to be there intact.  As pointed out by the critics of this investigation, many of the herbal supplements sold are highly processed, and this processing may degrade the DNA to a point where it will not be detected.

In DNA barcoding of medicinal plant material for identification (Techen, etal 2014 Current Opinion in Biotechnology Volume 25, Pages 103–110):

The isolation of pure, high molecular weight DNA is critical for the successful application of molecular methods. This can be quite a challenge since in processed medicinal plant material the DNA is often highly degraded or the plant material contains high amounts of polysaccharides, polyphenols and other secondary metabolites, such as, alkaloids and flavonoids. Various commercial kits and modified traditional methods are available to yield in good quality DNA from raw and powdered medicinal plant material, herbarium specimens, capsules, tablets, or tinctures for downstream applications 

In  DNA barcoding as a new tool for food traceability (Galimberti et al. 2013, Food Research International Volume 50, Issue 1,  Pages 55–63):

DNA is normally more resistant to industrial processes than other molecules, such as proteins (Martinez et al., 2003), and DNA fingerprinting methods can be successfully used in identifying animal or plant materials, even when in small traces (Bottero and Dalmasso, 2011, Costa et al., 2010, Kesmen et al., 2007, Mane et al., 2009, Martin et al., 2009 and Soares et al., 2010). Nonetheless, food processing causes chemical and physical alterations, degradation and fragmentation being the most common effects (Bauer, Weller, Hammes, & Hertel, 2003). DNA integrity largely influences the effectiveness of molecular methodologies (Hellberg and Morrisey, 2011, Meusnier et al., 2008 and Pafundo et al., 2007). DNA barcoding can have two advantages if compared to DNA fingerprinting approaches: i) it requires the amplification of a short DNA fragment (hence there is a lower risk of fragmentation), and ii) it is based on mitochondrial or plastidial genome (more preserved during processing).

 

The supplement industry is not regulated as a food or drug, but has its own regulations.  These rules are lax compared to those for drugs in that these products do not need to have FDA approval before selling on the market, and those claims do not necessarily need to stand to the same standard as a drug.  FDA requires that the herbal supplements are safe and that the ingredients listed on the label be in the product.  There is however, still the question whether these products actually have  any significant impact on health.

From the National Institutes of Health website:

Dietary supplements are not required to be standardized in the United States. In fact, no legal or regulatory definition exists for standardization in the United States as it applies to botanical dietary supplements. Because of this, the term "standardization" may mean many different things. Some manufacturers use the term standardization incorrectly to refer to uniform manufacturing practices; following a recipe is not sufficient for a product to be called standardized. Therefore, the presence of the word "standardized" on a supplement label does not necessarily indicate product quality.

In 2007, the FDA issued Good Manufacturing Practices (GMPs) for dietary supplements, a set of requirements and expectations by which dietary supplements must be manufactured, prepared, and stored to ensure quality. Manufacturers are now expected to guarantee the identity, purity, strength, and composition of their dietary supplements. For example, the GMPs aim to prevent the inclusion of the wrong ingredients, the addition of too much or too little of a dietary ingredient, the possibility of contamination (by pesticides, heavy metals such as lead, bacteria, etc.), and the improper packaging and labeling of a product.

Like other dietary supplements, botanicals are not required by federal law to be tested for safety and effectiveness before they are marketed, so the amount of scientific evidence available for various botanical ingredients varies widely. Some botanicals have been evaluated in scientific studies. For example, research shows that St. John's wort may be useful for short-term treatment of mild to moderate depression. Other botanical dietary supplements need more study to determine their value.

The dietary supplement industry has estimated sales of $6 billion, part of a $13 billion dietary supplements industry.  This investigation, while questionable in terms of methodology, may trigger further investigation into whether or not the dietary supplement industry is following questionable practices.

CBS/APFebruary 8, 2015, 3:59 PM
http://www.cbsnews.com/news/herbal-supplements-industry-lashes-out-at-fraud-claims/
Herbal supplements industry lashes out at fraud claims

ALBANY, N.Y. - DNA barcoding has exposed some infamous cases of food fraud, like cheap catfish sold as pricey grouper and expensive "sheep's milk" cheese that was really made from cow's milk.

But can it tell if a pill touted as an energy-booster contains ginseng or is just a mix of rice powder and pine?

Some scientists say yes, while industry groups and some independent experts say DNA testing alone is inadequate for analyzing botanical products that have gone through a lot of processing from leaf to tablet.

The Safety of Nutritional Supplements

An article in the New England Journal of Medicine warns about the dangers of nutritional supplements.  There is an increasing market of supplements, and unfortunately, the system for ensuring the safety of those supplements is inadequate.

These supplements are marketed to people looking to loose weight, to be more energetic, or to be less depressed, however, there have been instances where these supplements have been deadly or caused severe damage including liver failure.  Many of us buy into the notion that a pill can fix our issues.

We also overuse many of our normal vitamins and supplements often without the scientific evidence to support such claims.  In some cases, overuse can do more harm than good.

In a related case, there are parents who look to improve the health of their children through 'juicing'.  An article in Medical Daily shows there is a trend for children to take 'detox juice blends".  What works in adults may not be as good for children.


New England Journal of Medicine
http://www.nejm.org/doi/full/10.1056/NEJMp1315559
Perspective
Hazards of Hindsight — Monitoring the Safety of Nutritional Supplements
Pieter A. Cohen, M.D.

N Engl J Med 2014; 370:1277-1280April 3, 2014DOI: 10.1056/NEJMp1315559

Epidemiologists at the Centers for Disease Control and Prevention (CDC) recently confirmed what an astute liver-transplant surgeon in Honolulu already suspected: OxyElite Pro, a popular over-the-counter supplement, was responsible for a cluster of cases of severe hepatitis and liver failure.1 Although patients began to develop severe hepatitis in May 2013, the Food and Drug Administration (FDA), whose job it is to remove dangerous supplements from store shelves, did not learn of the cases until mid-September, 4 months later. By February 2014, the CDC had linked 97 cases, resulting in 47 hospitalizations, three liver transplantations, and one death, to OxyElite Pro. This dietary supplement was recalled, but nothing has been done to prevent another supplement from causing organ failure or death. Nor have any changes been made to improve the FDA's ability to detect dangerous supplements.

Concern with Dietary Suppliments Increases as Dietary Ingredient Recalled Due to Salmonella

An Illinois company is recalling its dietary ingredient after ‘several’ lots tested positive for Salmonella. This ingredient, made by a subsidiary’s plant in South Korean subsidiary, had already been used in a number of products including a children’s product - which was also recalled (http://www.fda.gov/Safety/Recalls/ucm311050.htm). The ingredient is an undigestable fiber made from milk and is marketed as an aid for the health of the immune and digestive systems.

There has been a growing concern with dietary supplements. Most of this concern has related to medical claims that are made. Some substances do not live up to the claims, while others may actually have adverse effects (http://health.wolterskluwerlb.com/2012/01/dietary-supplement-concerns-in-2012/ and http://www.fda.gov/Food/DietarySupplements/Alerts/default.htm).

There has also been issue with how some of these are processed. A Chicago Tribune article (below) reported that half of the 450 firms inspected had violations. In the UK, it was just reported that 40% of dietary supplements were irradiated illegally (http://www.dailymail.co.uk/health/article-121486/Concerns-dietary-supplements.html).  

Sales of dietary supplements continues to increase. Consumers view dietary supplements as a way to prevent health issues. Some see herbal supplements as more natural. In many cases, supplements are less expensive than over-the-counter drugs. Without the pharmaceuticals industry’s requirements for scientific research to back label claims, an increasing number of companies have entered this market, including pharmaceutical and food companies. 

Westchester firm recalls salmonella-contaminated supplements
No illnesses have been reported; FDA investigating
http://www.chicagotribune.com/health/ct-met-salmonella-supplements-20120719,0,6096142.story

By Trine Tsouderos, Chicago Tribune reporter
July 19, 2012

 Concern over salmonella contamination has prompted a Chicago-area firm to recall nearly 40,000 pounds of a dietary ingredient, a move that in turn prompted several recalls of supplements containing the suspect material.

U.S. Food and Drug Administrationofficials said they are investigating whether the ingredient, sold by Westchester-based Ingredion and made in a subsidiary's plant in South Korea, wound up in other dietary supplements sold to consumers and whether more recalls are necessary.