Fifteen Illegally Sold Diabetes Treatments   (July 25, 2013)

The FDA has just done us all a favor, exposing fifteen diabetes scams at once. I  will tackle a brief review of all 15 here. The FDA’s listing is available at their website, at Illegally Sold Diabetes Treatments.

Most of these products can be found at their company's websites. Sometimes it can be seen that the companies have already cleaned up their offending descriptions. Using a little-known trick, archived versions of some of these webpages can be found at Archives.org  at their “WaybackMachine” and then compared to the current versions. All internet searches for this essay were done on July 25, 2013.

1.

Anastasia Marie Laboratories, Inc.

Diabetes Product Name(s): Anastasia Diapedic Foot & Leg Treatment

FDA accusation: unapproved and misbranded drug

FDA Warning Letter is at

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm361849.htm

Current status: At their website, they discuss “FDA Approval” and imply that they have it: “FDA validation of composition, formulation and manufacturing is your assurance that Anastasia products are completely safe, therapeutically reliable and fully tested to meet rigorous government standards.”

This company’s website also indicates that a past president of the ADA is a “co-founder and Chief Medical Advisor.” http://www.amlab.com/about/executive-team/ Wonder if he’ll advise them on what to say in their response letter to the FDA, or if he was hired as a figurehead?

2.

www.bestcheapmedsonline.com

Diabetes Product Name(s): Exermet GM, Galvus, Nuzide, Triexer, and unapproved versions of Januvia

FDA accusation:  Internet Marketing of an Unapproved and Misbranded Drug

FDA Warning Letter:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm361838.htm

Current status: As of today  the website is  described as a “suspended domain” by Whois

http://www.networksolutions.com/whois/results.jsp?domain=bestcheapmedsonline.com

If you go to that domain name today, you’ll only see a generic advertisement for other websites. But if you want to see their website in its former glory, you can use the Wayback Machine to take a partial peek, where they bragged that “When it comes to healthcare - compromise is not a solution! We offer proven Canadian medications Quality”

http://web.archive.org/web/20130512221331/http://bestcheapmedsonline.com

(unfortunately, the Wayback Machine doesn’t retain graphics reliably). Looks like they sold just about everything, not just diabetes medications.

3.

Glytain Internal Remedies, Inc.

Diabetes Product Name(s): Glytain

FDA accusation: product  is being promoted for the prevention and treatment of diabetes. 

FDA Warning Letter is at

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm361859.htm

Current status: Their website is still there, and today it still claims “if you have been diagnosed with Pre-Diabetes, Type 1 Diabetes or Type 2 diabetes, you can still turn your health around by eating right, exercising and taking Glytain to help lower your blood sugar.” Sounds like a drug to me, and obviously the FDA thought so.

4.

Health Care Products, Hi-Tech Pharmacal Co.

Diabetes Product Name(s): Zostrix Diabetic Foot Pain Relief Cream, Zostrix Diabetic Joint & Arthritis Pain Relief Cream, and Diabeti-Derm Antifungal Cream

FDA accusation: As presently formulated, labeled, and promoted, these products are unapproved drugs

FDA Warning Letter:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm361863.htm

Current status: As of today, their website no longer has the word diabetes (per Google searches), and the three products the FDA was concerned about are no longer listed on their product webpage.

5.

Health King Enterprises & Balanceuticals Group, Inc.

Diabetes Product Name(s): Sugar Balancer

FDA accusation: products are intended for use as drugs -- because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

FDA Warning Letter:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm361842.htm

Current status: Their website’s description of their “Sugar Balancer” product  has been cleaned up, and no longer states that “Chinese Use: Diabetes” (which can be found at the version at the Wayback Machine) and now weasels around the FDA regs by avoiding  the word diabetes, and instead saying “Chinese medicine uses this time-honored formula to supplement the Qi and Yin and to support healthy blood and urine sugar level.” I didn’t spend the time to check what they might have done to clean up other webpages that the FDA was concerned about.

6.

The Magni Group, Inc. dba MagniLife

Diabetes Product Name(s): Diabetic Neuropathy Foot Cream, Diabetic Foot Cream, and Diabetic Hand & Body Cream

FDA accusation: marketing of these products violates the Federal Food, Drug, and Cosmetic Act 

FDA Warning Letter:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm361872.htm

Current status: Their website still claims that their creams do what the FDA says they  shouldn’t be claiming to do.

7.

Naturecast Products

Diabetes Product Name(s): Eradicator

FDA accusation:  promoted for the treatment of diabetes, which causes these products to be drugs

FDA Warning Letter

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm361855.htm

Current status: “Eradicator” seems to be gone from their website. For instance, Google shows a page for it at www.naturecastproducts.com/eradicator/ but clicking on the link now goes to their homepage.

Which is a shame, as that’s the most innovative name that a product has been given since the movie Terminator spawned the neologism, “the  Governator.”

8.

Nature's Health Supply, Inc.

Diabetes Product Name(s): Diabetes Daily Care

FDA accusation:  intended for use in the cure, mitigation, treatment, or prevention of a disease.

FDA Warning Letter:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm361890.htm

Current status: The webpage for this product has been drastically rewritten compared to the version at the Wayback Machine that was archived October 21, 2012. The author of the webpage has deleted many phrases that the FDA objected to. For instance, the phrase “Many men have also reported increased or restored sexual function” is gone.

9.

Neuliven Health

Diabetes Product Name(s): Glucocil

FDA accusation: intended for use in the cure, mitigation, treatment, or prevention of disease. 

FDA Warning Letter:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm361881.htm

Current status: As of today (July 25, 2013), it seems that their website’s text that the FDA was concerned about has not been changed. The interested reader is also asked to  see my previous essay on this product, An OTC "Glucose Stabilizer"

10.

Nutrient Synergy

Diabetes Product Name(s): Nepretin

FDA accusation: the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. 

FDA Warning Letter:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm358998.htm

Current status: The website cannot be accessed.

11.

PharmaTerra

Diabetes Product Name(s): ProBeta

FDA accusation:  this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease.

FDA Warning Letter:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm361869.htm

Current status: The website is “Down for Maintenance.”

12.

Amrutam Life Care Pvt. Ltd.

Diabetes Product Name(s): Diexi

FDA accusation: your products “Diexi” and “Zoom” contain undeclared ingredients, metformin [a drug for diabetes] and sildenafil [a drug for ED], respectively.

FDA Warning Letter:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/CyberLetters/UCM361549.pdf

Current status: The website cannot be accessed.

13.

Enhance Nutraceutical

Diabetes Product Name(s): Diaberex

FDA accusation: you market products that are unapproved new drugs and misbranded drugs

FDA Warning Letter:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/CyberLetters/UCM361551.pdf

Current status:

The webpage for this product has been drastically rewritten compared to the version at the Wayback Machine that was archived on May 21, 2012. The author of the webpage has deleted many phrases that the FDA objected to. For instance, the following phrase is gone: “Advanced Nutraceutical  Stops This Silent Killer Before It Destroy You... And those You Love!”

Although it’s not an FDA issue, there’s an ethical issue on this webpage: the date that it is purported that a letter addressed to “Dear friend with Diabetes” was written. It’s today. Even the version at the Wayback Machine (from May 21, 2012) was written today (July 25, 2013). The HTML coding for the webpage can be accessed, and it clearly shows that a script was used when generating this webpage, so the date will always appear to be the date that the webpage is displayed.

  

14.

INS Bioscience Berhad,HLS International Sdn. Bhd.,Easy Pha-max

Diabetes Product Name(s): Insupro Forte

FDA accusation: your product “Insupro Forte” contains the undeclared ingredient, glyburide

FDA Warning Letter:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/CyberLetters/UCM361546.pdf

Current status:

One of the websites the FDA referenced as owned by this company still has the text that the FDA objected to, such as “It can replace medicine in the treatment of diabetes ”

15.

Zhengzhou Thousand Economies Science and Technology Co., Ltd. 

Diabetes Product Name(s): Jiang Tang Yi Huo Su Jiao Nang (translated – anti-diabetic pancreatic capsule)

FDA accusation: The product contains three active pharmaceutical ingredients, including one that was removed from the U.S. market because of the risk of serious side effects.

FDA Drug Alert

http://www.fda.gov/Drugs/DrugSafety/ucm361618.htm

Current status: FDA has posted a webpage about this product,

FDA alerts consumers of undeclared drug ingredients in over-the-counter diabetes product

In summary:

Two companies with supposed supplements that contain active but undeclared drugs.

Several with websites that have vanished.

Some websites that have changed their wording to weasel around the FDA’s requirements.

Some websites that seem to have done nothing.

Altogether, a pretty tawdry crowd.