Diabetes Claim Warnings Signal Spread Of Violative Products

CDER says a product marketed as a supplement contains three pharmaceutical ingredients, including phenformin, banned in 1978 because of the occurrence of lactic acidosis in patients. Trade group executives say warnings to 14 firms making diabetes and other disease claims demonstrate that noncompliant businesses will target more health conditions of growing concern to consumers.

FDA’s warnings about 15 consumer health products fraudulently claiming to treat diabetes, including one containing a banned Rx ingredient, show that noncompliant claims are spreading in the U.S. beyond those for weight loss, sexual enhancement and bodybuilding.

Dietary supplement trade group executives say FDA’s July 23 announcement of warning letters to 14 firms making diabetes and other disease claims signals that the Dietary Supplement Health and Education Act works to regulate the industry, but also point out that noncompliant businesses will target additional health conditions of growing concern to consumers.

“As long as there is a market, they’re going to try and focus in on that market,” said Cara Welch, the Natural Product Association’s senior VP for scientific and regulatory affairs.

United Natural Products Alliance Executive Director Loren Israelsen said the firms FDA warned about making fraudulent diabetes claims almost certainly are not the only businesses committing the same violation, including about other health conditions, and they did not begin making the claims only recently.

FDA’s announcement “does not suggest there was a sudden surge in these kinds of products on the market,” Israelsen said.

“They are out there – these are 15 examples. It just underscores the nature of the problem, these sorts of undeclared or illegal substances in products that are labeled as dietary supplements,” he added.

Not all the products at issue are supplements, however. Hi-Tech Pharmacal Co. Inc.’s Zostrix pain relief topical OTC drugs also were included in FDA’s enforcement sweep (see story this issue, (Also see "Double Whammy For Hi-Tech’s Zostrix: FDA Warning, NAD Review" - Pink Sheet, 29 Jul, 2013.)).

Adulteration, Unapproved Drugs, Mislabeling

FDA’s Center for Drug Evaluation and Research warned consumers that Jiang Tang Yi Huo Su Jiao Nang, a product marketed online as a dietary supplement by Zhengzhou Thousand Economies Science and Technology Co. Ltd., contains three active pharmaceutical ingredients, including phenformin, which FDA ordered off the market in 1978 because of its association with lactic acidosis in diabetic patients using the drug.

The product also contains active ingredients found in the FDA-approved Rx drugs glyburide and metformin, indicated for the management of type 2 diabetes. FDA identified Zhengzhou Thousand in a consumer alert but has not sent the firm a warning letter.

FDA said it is unaware of reports of any injury or illness associated with Zhengzhou Thousand’s product or the others identified in the 14 warning letters posted July 23 following the agency’s review of each firm’s website and product labeling (see table below).

The warnings explain that the violative claims render the products unapproved new drugs and misbranded supplements. Some of the products also make claims for inflammation, erectile dysfunction or weight loss.

In a consumer advisory, FDA said the violative claims could cause consumers to delay seeking proper medical treatment for their diabetes, which affects nearly 26 million people in the U.S. “The FDA is committed to protecting consumers from the dangers of these illegally sold products,” said Howard Sklamberg, director of CDER’s Office of Compliance.

The claims also might deceive some consumers into using inappropriate products to treat their medical conditions, the agency added in a separate release about enforcement against the firms making the fraudulent claims.

“People with chronic or incurable diseases may feel desperate and become easy prey. Bogus products for diabetes are particularly troubling because there are effective options available to help manage this serious disease rather than exposing patients to unproven and risky products," said Gary Coody, FDA’s national health fraud coordinator.

Claims Compliance Complex

While the majority of spiked supplements are in the weight loss, sexual enhancement and bodybuilding categories, officials with FDA’s Center for Food Safety and Applied Nutrition in the past year have noted an increase in supplement products adulterated with prescription ingredients for diabetes and for inflammation.

Both responsible and noncompliant firms have increased their offerings targeting diabetes and pain management, given the prevalence of these conditions, CFSAN Director Michael Landa said in October 2012 (Also see "Spiked “Supplements” For Diabetes, Pain On The Rise" - Pink Sheet, 15 Oct, 2012.).

NPA’s Welch noted that firms sometimes make violative claims inadvertently, especially when they lack assistance from someone qualified to advise on health claims.

“This is not an area you want to wade into uninformed,” Welch said.

She suggests hiring consultants or lawyers, “people who have done this before, who have the experience, and understand what it is FDA is looking for” in terms of the agency’s current enforcement priorities.

The impetus for a violative claim, no matter if it is unintentional, is sales, Welch added. Heart health, cardiovascular problems, cholesterol levels and inflammation, as well as diabetes, are conditions that concern consumers and that could be targeted in violative claims.

“Those are definitely something consumers are going to be drawn to, very specific claims,” Welch said.

“A lot of what we tout as leading to a healthy lifestyle doesn’t really get at a very specific concern and doesn’t necessarily set you apart on the shelf.”

Rend Al-Mondhiry, the Council for Responsible Nutrition’s regulatory counsel, pointed out “most mainstream companies are following the law, and not making claims that violate FDA regulations.”

Additionally, industry self-regulatory programs such as the National Advertising Division’s supplement advertising review, which CRN supports, protect consumers and the industry by identifying misleading or unsubstantiated claims. Violative disease claims, including diabetes claims, identified in NAD reviews are sometimes forwarded to FDA or the Federal Trade Commission in the face of continued noncompliance.

“Where companies are making illegal claims that put consumers at risk, we expect FDA to continue to enforce the law and the responsible industry to fully support this enforcement,” Al-Mondhiry said.

And products marketed as supplements that should be targets for enforcement usually are obvious, Israelsen noted.

“Products that contain those kinds of ingredients almost always will be making a specific drug-like claim. That’s always a tip-off. Why would you make a claim like a diabetes drug if not to attract diabetics?”

“It’s really a disservice to the dietary supplement industry that companies of that sort are selling drugs. They are knowingly selling drugs and therefore they are illegally labeled as dietary supplements and they should not be labeled as dietary supplements at all,” Israelsen added.

Disease Claims Prompt Warnings
Recipient/Products	Examples of Violative Claims
Anastasia Marie Laboratories Inc. (Oklahoma City) Diapedic	“Temporarily relieves pain of: diabetic neuropathy” “High performance treatment penetrates to cellular level to soothe the effects of diabetic neuropathy and alleviate pain. Ideal for diabetic or non-diabetic use.” “Foot & Leg Treatment penetrates to cellular level to relieve diabetic neuropathy and promote circulation.”
Internal Remedies Inc. , dba Glytain (Hollywood, Fla.) Glytain	“Control your Diabetes Naturally” “An all-natural treatment for diabetes that … can help to naturally reduce blood sugar levels.” “Effective because it works naturally affecting the body at a cellular level to reduce insulin resistance and assist glucose regulation.”
Hi-Tech Pharmacal Co. Inc. (Amityville, N.Y.) Zostrix	“For Relief Of Diabetic Foot Pain” “The effectiveness of treating diabetic foot pain is one reason why Doctors and Pharmacists recommend Zostrix.” “Joint and Arthritis Pain Relief Cream not only attacks arthritis pain with the same powerful ingredient as Zostrix HP Arthritis Pain Relief Cream, but this special formula for people with diabetes also has an important ingredient to stimulate circulation.”
The Magni Group Inc. , dba Magnilife (McKinney, Texas) Diabetic Neuropathy Foot Cream; Fibromyalgia Relief; Sciatica Relief; Tinnitus Relief; Urinary Incontinence Relief	"Neuropathy pain in feet? Calms ... sensations caused by diabetic nerve pain" "Gelsemium sempervirens 6X HPUS ... Acts upon nerves" "I have had neuropathy for 5 years. The tingling and burning in my feet and legs has been terrible. ... I tried your Magnilife Diabetic Neuropathy Cream ... within 5 minutes the pain eased."
Naturecast Products (Coral Springs, Fla.) Eradicator	“Eradicates the causes of uncontrolled blood sugar by packing your system with all natural, proven and biochemically powerful nutrients that regulate your blood sugar levels.” “Chromium helps regulate blood sugar levels by collaborating with insulin in facilitating the uptake of glucose into the cells.”
Nature’s Health Supply Inc. (Camarillo, Calif.) Diabetes Daily Care; Prostate Miracle; Estrogen Balance; Cholesterol Metabolizer; Pectin Plus; D Max; Immune System Plus; Coral Calcium; Super Sea Veg; Barley Green Premium	Under the tab, “Diabetes Natural Cure”: “Unique, Natural Formula, which Safely and Effectively Improves Sugar Metabolism in Type 1, Type 2, Hyperglycemia … and Pre-Diabetes.” “Although Diabetes Daily Care does not “cure” diabetes, it is very effective in managing and controlling diabetes … we consider it a treatment” “These supplements can also protect your tissues (eyes, kidneys, blood vessels) from the damage diabetes often causes.” “Every diabetic should take these proven supplements: Cinnamon, Alpha Lipoic Acid, Chromax, Vanadium, Banaba Leaf, Momordica, Gymnema Sylvestre and Fenugreek. Diabetes Daily Care is unique, because it contains ALL of these vital nutrients TOGETHER.”
Neuliven Health Inc. (San Diego) Glucocil	“Lower fasting blood sugar levels up to 29%” “Since using Glucocil, my blood sugar level has been under control.” “The natural and safe ingredients clinically proven to help manage blood sugar levels.” “A natural supplement specifically designed to help prediabetics and type 2 diabetics.”
PharmaTerra Inc. (Mercer Island, Wash.) ProBeta	“The world’s most extensively researched and clinically tested Gymnema sylvestre product.” “Type I Diabetics: Key Results from ProBeta after six months: “Treatment with ProBeta resulted in significant reductions in fasting blood glucose levels in all cases.” 34% reduction in fasting blood glucose 22% reduction in HbA1c 14% reduction in external insulin requirement”
Health King Enterprise & Balanceuticals Group Inc. (Chicago) Sugar Balancer	“Chinese Use: Diabetes” “Lowers the blood glucose … prevents and treats diabetes … antagonizes the rise of blood sugar.” “Gastric infusion of LBP lowers the blood glucose in normal mice, prevents and treats hyperglycemia.” “Fructus Corni alcohol extract yields marked effect of lowering blood sugar in diabetes animal models … lowers the platelet aggregation … of whole blood.”
Nutrient Synergy Inc. (Longmont, Colo.) Nepretin	“A revolutionary treatment for diabetic retinopathy and nephropathy.” “Designed to control complications of diabetes” “Symptoms of diabetic retinopathy were dramatically slowed, stopped, or even reversed … when Nepretin was taken orally on a daily basis.” “An all-natural supplement designed to slow, stop, or reverse diabetic retinopathy.” “May also be used as a preventive strategy for a large percentage of the diabetic population.”
Amrutam Life Care Pvt. Ltd. (Surat Gujarat, India) Diexi	“Herbal Diabetic Health Supplement” “Normalizing blood sugar levels naturally.” “Is an Anti-Diabetic Herbal Formula; that provides an effective treatment to relieve all symptoms related to diabetes.” “May help increase insulin sensitivity and glucose tolerance, requiring less insulin use.”
Enhance Nutraceutical (Darul Ehsan, Malaysia) DaibRex	“The New Diabetes Miracle” “The New Nutraceutical Breakthrough in Conquering Diabetes” “Say Goodbye To High Blood Sugar Level & Painful Daily Insulin injection FOREVER!” “Not only did this inexpensive therapy enable you to fight & eliminate Type 2 Diabetes … and massive complications that derive from Type 2 Diabetes. … It can also lower your cholesterol level, help in hypertension and decrease the chance of YOU getting cancer!”
INS Bioscience Berhad HLS International Sdn. Bhd. Easy Pha-max (Puchong, Selangor, Malaysia) Insupro Forte	“Savior of Diabetes” “Momordicoside and charantin enables your body to have the power against Diabetes and its complications that may occur.” “Say goodbye to Diabetes!” “Insupro Forte is a plant insulin”
Origin BioMed (Halifax, Nova Scotia, Canada) Neuragen PN	“Topical treatment for severe, disabling nerve pain.” “Is effective in relieving pain in a variety of nerve related conditions such as diabetic neuropathy, shingles and fibromyalgia.” “Easy to use for localized nerve pain”
Fundacion Private Whois , www.bestcheapmedsonline.com (Panama) Exermet GM; Galvus; Nuzide; Triexer	The firm lists the products on its website under the heading “Antidiabetic.”