Friday, September 18, 2015

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.

When lead builds up in the body, it can cause serious health problems, including permanent damage to the nervous system. This can result in learning difficulties, developmental delay, and other long-term health problems, especially in young children. If a pregnant woman is exposed to high levels of lead, it could affect her unborn child in the same way, or may cause miscarriage. The problems that might occur depend on how much lead a person consumes and how long they consume it. Because lead builds up in the body over time, even apparently healthy people could have high levels of lead in their blood. Some signs of lead poisoning may include loss of memory, unexplained high blood pressure, severe constipation or pain, numbness or tingling of the arms and legs.

Excessive exposure to mercury can cause kidney or gastrointestinal problems with short-term use, while exposure over a month or longer could lead to neurological problems and potentially be fatal. High levels can also affect the development of the nervous system of a pregnant woman’s unborn child. Some signs of mercury poisoning may include loss of coordination, vision or hearing, "pins and needles" sensations usually in the hands, feet, and around the mouth, or muscle weakness.

The FDA recommends that consumers avoid the following products:
Baidyanath brand Agnitundi Bati
Baidyanath brand Arogyavardhini Bati
Baidyanath brand Brahmi Bati
Baidyanath brand Chitrakadi Bati
Baidyanath brand Gaisantak Bati
Baidyanath brand Marichyadi Bati
Baidyanath brand Rajahpravartini Bati
Baidyanath brand Saptamrit Lauh
Baidyanath brand Sarivadi Bati
Baidyanath brand Shankh Bati 

Who should know

Anyone taking any of these Baidyanath brand Ayurvedic dietary supplements should be aware of the potential for heavy metal poisoning. In general, Infants, small children, pregnant women, and people with underlying kidney disorders tend to be more at risk for heavy metal poisoning. Heath care providers who see patients with symptoms of lead or mercury poisoning should ask whether they are taking or have taken these Ayurvedic dietary supplements.

What to do
If you are taking any of these Baidyanath brand Ayurvedic products, stop taking them immediately and consult your health care provider. Even if you are not having symptoms and feel healthy, you could have high levels of lead or mercury in your body.
If you believe that you are having an adverse event related to these products, seek immediate medical care or advice from a poison control center.
Pregnant women and parents of children who may have taken any of these products should ask their health care provider whether medical testing may be warranted. 

Why this advice is important
Certain Baidyanath brand Ayurvedic dietary supplements that contain high levels of lead and mercury are dangerous and can cause serious health problems.

FDA Recall Notice
Butala Emporium, Inc. Recalls Eleven Ayurvedic Dietary Supplements Because of Elevated Levels of Lead and Mercury

Shaswat Butala

FOR IMMEDIATE RELEASE — September 15, 2015 — Jackson Heights, NY — Butala Emporium, Inc of Jackson Heights, NY, is voluntarily recalling eleven Ayurvedic (dietary) supplements (listed below) because the products were found to contain elevated lead and mercury levels which may cause health problems to consumers, particularly infants, small children, pregnant women, and those with underlying kidney disorders if consumed.The concentration of lead exceeds the recommended daily lead exposure for children less than 6 years of age and women of childbearing age and would likely be injurious to health. If a child or a pregnant woman is exposed to lead for a protracted period of time (e.g., weeks to months) permanent damage to the central nervous system, learning disorders, developmental defects, and other long-term health problems can occur. The problems that might occur are dependent on the duration and degree of exposure.

The mercury levels in these products are high and exceed the weekly intake exposure and would likely be injurious to health. The elevated mercury levels in these products with short term use can cause kidney, stomach and intestinal (or gut) symptoms, while month-long use of these products could be potentially lethal. Mercury consumption at these levels can also cause psychiatric and personality disturbances, ataxia (or loss of coordination), visual loss, hearing loss, and other neurological conditions particularly exposed in utero. Butala is notifying individuals not to consume this product.

Baidyanath brand Saptamrit Lauh--Batch No. SPL-04, Expiry Date 4/2018
Baidyanath brand Rajahpravartini Bati--Batch No. RAJ-15 0 & 126, Expiry Date 1/2019 & 07/2016
Baidyanath brand Sarivadi Bati--Batch No. SRI-09, Expiry Date 04/2018
Baidyanath brand Shankh Bati--Batch No. SHN-02, Expiry Date 08/2018
Baidyanath brand Marichyadi Bati--Batch No. 200, Expiry Date 08/2017
Baidyanath brand Agnitundi Bati--Batch No. 018, Expiry Date 02/2016
Baidyanath brand Arogyavardhini Bati--Batch No. 018, Expiry Date 03/2017
Baidyanath brand Sarivadi Bati--Batch No. SARI-015, Expiry Date 01/2019
Baidyanath brand Brahmi Bati--Batch No. HGB-18, Expiry Date 03/2019, Batch Nos. 244 & 242, Expiry Date 03/2017 (products without Batch No. or Expiry Date are subject to this recall)
Baidyanath brand Gaisantak Bati--Batch No. GAI-09, Expiry Date 08/2018 and Batch No. 141, Expiry Date 10/2017
Baidyanath brand Chitrakadi Bati--Batch No. 193, Expiry Date 02/2018

The 80-count-capsules are packed in white, plastic bottles with green, yellow or orange labeling under the brand name “Baidyanath” made by Shree Baidyanath Ayurved Bhawan (P) Ltd. 1 Gupta Lane, Kolkata, India and top cap sticker with imported by Butala Emporium

The product was distributed in NY through retail stores and to consumers as single unit purchases via the firms internet site within CA, CT, FL, HI, MA, NJ, OH, PA, VT, D.C. and PR).

No complaints or illnesses have been received to date.

The recall was initiated after it was discovered that the products contain high levels of lead and mercury based on NYC Department of Health laboratory and U.S. Food and Drug Administrating testing.

Pregnant women and patients with underlying kidney problems who may have consumed any of the above products should consult with their physician or health care provider. For more information, consumers should contact their local poisoning prevention program or local public health department.

Consumers who have purchased these products are urged not to consume the product and should return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-718-899-5590, Monday – Friday, 9 am – 5 pm ET or email

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online:
Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

FDA Recall Notice
Iowa Select Herbs, LLC Issues a Nationwide Recall of Its Products Pursuant to Consent Decree Issued by the Federal Court for the Northern District of Iowa


FOR IMMEDIATE RELEASE — September 15, 2015 — Cedar Rapids, IA — Iowa Select Herbs, LLC (the "Company") is conducting a consumer recall for inventory sold between January 1, 2015 and August 17, 2015 pursuant to a Consent Decree issued by the federal court for the Northern District of Iowa. The Consent Decree was issued because the Company manufactured and distributed unapproved new drugs, misbranded drugs, misbranded dietary supplements, and dietary supplements not manufactured in compliance with the current Good Manufacturing Practice regulations for Dietary Supplements, and therefore adulterated. There are no reports to date of side effects or adverse events.

The recalled products are herbal extracts marketed under the Iowa Select Herbs brand in either an alcohol or alcohol free (A/F) solution packaged in various sizes from 1oz to 1 gallon. The following lots are being recalled:

The recalled products were sold nationwide between January 1, 2015 to August 17, 2015 to wholesalers and consumers using the Company's website and through online marketplace websites, such as Amazon and Ebay.

Iowa Select Herbs is notifying its wholesale and retail customers through written correspondence. We urge consumers who have purchased these products to immediately discontinue their use and contact their physician if they have experienced any problems that may be related to taking these products. The Company is advising consumers to return the products to their place of purchase. Consumers may also return products directly to Iowa Select Herbs. Customers can call the Company at 319-826-1000 Monday through Friday from 9:00 am - 5:00 pm CST for instructions on the return and refund process.

Any adverse events or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:

No comments:

Post a Comment