The dietary supplements, manufactured by GLOBE ALL WELLNESS,LLC  included various lots of SlimXtreme, SlimXtreme Gold, SlimPlus, SlimLee, GelSlim, SlimDrops, and Colonew. These all contained the banned prescription MERIDIA (heart disease and strokes).
Globe All Wellness also made drug claims about some of its dietary supplements, promoting them for lowering blood pressure and cholesterol, in addition to weight loss. The company was warned by the FDA in February 2012 when it was discovered that SlimXtreme and another supplement, ViaXtreme Ultimate Sexual Enhancer Dietary Supplement for Men, contained sibutramine
 
There was a voluntary recall of the energy supplement MET-Rx Extreme Thermo Rage Watermelon 8 fl. oz. (Manufactured by MET-Rx Nutrition, Inc.) due to bacterial contamination (Acetobacter lovaniensis)). MET-Rx Extreme Thermo Rage contains caffeine, vitamin C, niacin, vitamin B6, potassium chloride, sodium, taurine, beta-alanine, L-Tyrosine, L-Carnitine, 5-HTP, yerba mate extract, green tea and yohimbe. It was promoted for energy and increased mental focus. Remember--Energy drinks are not safe to begin with due to cardiovascular side effects.
 
On January 29, 2013, the FDA issued a warning letter to M.D.R. Fitness Corp. following a facility inspection which found violations of good manufacturing practices which cause the company’s products to be adulterated.A review of the company’s website also found statements made about the dietary supplements Artery Factors, Cardio Tone, Cranberry Concentrate, Fitness Tabs for Men and Longevit-E to be drug claims. The FDA also noted that typing the key words “cancer” or “diabetes” into the M.D.R. Fitness website’s product search produced results including Fitness Tabs for Men, Longevit – E and others products, and found that this implied the supplements were intended for use in the “diagnosis, cure, mitigation, treatment or prevention of such diseases. All supplements have to have a disclaimer on their label stating that the product is not intended to diagnose or treat any illnesses—check the label of any supplement that you use.
 
On January 25, 2013, the FDA issued a warning letter to NX Generation Ltd. following a facility inspection which found the company’s products, including Unique Children’s Chewable Vitamins and Unique Prenatal Care dietary supplement products, to be adulterated because the products were prepared, packed or held under conditions that violate current good manufacturing practices for dietary supplements. Violations include failure to maintain proper maintenance and quality control documentation.
 
 
 
KAIZEN TOTAL WELLNESS
LAKEWOOD RANCH, FLORIDA
941-556-7788
 

1.  On January 23, 2013, Health Canada warned consumers that certain batches of the Chinese dietary supplements [W.S.] Tian Ma Toutong Wan, Shi Hu Ye Guang Wan (Ye Guang Wan), Nai Chang Ming Yan Pills (Ming Yan Pills), [Fung Shing Pai] Tian-Ma Wan and Bak Foong Pills were found to contain excessive amounts of lead or mercury.
While these supplements are not authorized for sale in Canada, they may be available for purchase by Canadian and U.S. consumers through online retail websites.
Excessive levels of lead can cause abdominal pain, anemia, changes in blood pressure, reproductive disorders such as miscarriage, weakness, concentration problems, weight loss, insomnia, dizziness, and kidney and brain damage. Excessive levels of mercury can cause irritability, tremors, memory loss, insomnia, concentration problems, and kidney and brain damage.
 
2.  On December 17, 2012, Performance Plus Marketing, Inc. issued a recall of male sexual enhancement supplements Libigrow, Libigrow XXXtreme, Blue Diamond, Blue Diamond Platinum, Mojo Nights, Mojo Nights Supreme, and Casanova because they were found to contain undeclared sulfoaildenafil and thioaildenafil.
Sulfoaildenafil and thioaildenafil are chemical analogues of sildenafil, the active ingredient in prescription drugs for the treatment of erectile dysfunction. These ingredients can cause symptoms like headache and flushing, and can interact with medications containing nitrates such as nitroglycerine, resulting in dangerously low blood pressure. Consumers who have purchased these supplements should not take them and should contact their healthcare provider if they have experienced any adverse side effects
 
3.  On October 5, 2012, the FDA issued a warning letter to Food for Health International, LLC following a facility inspection which found the company’s products, including Activz brand Vitamin D, Potassium Iodine, Organic Vitamin C, Whole 9 (a fruit and vegetable meal replacement shake) Control and VMA (a vitamin, mineral and enzyme blend), to be adulterated because they were prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
In addition, the agency found statements on www.foodforhealthinternational.com that promoted the dietary supplement Activz Control as a drug. The supplement was promoted for blood sugar control, reducing bad cholesterol and decreasing hypertension, and was described on the website with statements such as “…Help body stabilize blood sugar,” “Assists the body by . . . Reducing Bad Cholesterol . . . Decreasing hypertension,” “Avoid blood sugar spikes with a unique blend of phytonutrients . . . that help your body stabilize blood sugar levels . . . .” and “Contains . . . antioxidants to fight free radicals that cause . . . disease.”
 
4.  On January 23, 2013, Health Canada advised consumers not to use certain batches of Muscletech Hydroxystim capsules which were found to contain DMAA (1,3-dimethylamylamine) and have been recalled by their distributor. DMAA can increase blood pressure and the risk of cardiovascular events, and has been linked to at least two deaths. It is not allowed to be sold as a dietary supplement ingredient in Canada or the U.S. (See FDA Says DMAA Can't Be Sold as a Supplement).
Hydroxystim is promoted as a “thermo-stimulant” for an energy and metabolism boost during exercise. According to the Muscletech website, Hydroxystim has been reformulated, and neither DMAA nor geranium oil (sometimes used as another name for DMAA) is listed on the new label

Although milk thistle may lower blood sugar, cholesterol and possible some types of cancer, it is best known for its healthy effects on the liver in response to both infection and drug toxicity.

Just how effective it is remains to be seen as more studies need to be conducted.

What is interesting is the lack of QUALITY MILK THISTLE products on the market.  According to Consumerlab.com, 7 out of 11 supplements that were tested failed to pass their quality review. Some due to contaminants and others due to poor quality ingredients. The supplements that passed include:

          Dr. Whitaker Milk Thistle

          Jarrow Formulas Milk Thistle

          Shaklee Liver DTX

          Trunature (COSTCO)

 On October 3 ,2012 the FDA once again issued a report warning supplement makers to stop making illegal medical claims for their products.

Unless there is medical proof, the product must state that the supplement is not intended to treat or cure ANYTHING!
One investigation found that 20% of weight loss supplements made illegal claims.
The Department of Human and Health Services looked at 127 products, of which 21 submitted studies to try to get a medical claim on their label.Only 4 had proper documentation (not for scientific documentation as they were lacking the proper information needed to receive approval)
Remember, most vitamins and supplements are worthless. READ THE LABEL and as always BUYER BEWARE.
 
KAIZEN TOTAL WELLNESS
LAKEWOOD RANCH, FLORIDA
941-556-7788

WHOLE GREENS/POWDERS

It is being promoted to cause weight loss in people by promoting fat breakdown.
 
It is found in very small amounts in the fruit of raspberries (provides the aroma).The ingredient in supplements may, however, be synthetic, due to lower costs.

It has been found to be safe as a food additive, but no safety studies at amounts in supplements --100 mg or more per day. (In comparison, 1 pound of raspberries provides about 1 mg of ketone.) Due to lack of information about possible metabolic and other effects, people with pre-existing health conditions (diabetes, high cholesterol, high blood pressure, etc.) should be monitored by a health care professional when using raspberry ketone. Be aware that raspberry ketone is different from the supplement raspberry leaf.

 If  you use raspberry ketone, use it with some caution --and be aware that the quality of supplements can suffer when companies rush to meet a new demand.

Please be aware that there is no such thing as a supplement to break down fat. In order to burn fat, one must eat smart and exercise to MAKE muscle. Remember that if stuff like this really worked, there would be no fat people!

KAIZEN TOTAL WELLNESS CENTER
Lakewood Ranch, Florida
941-556-7788

Those of you who are my patients or who read my blogs are well aware that, although I think vitamins and supplements, for the most part, are unnecessary, I am a BIG fan of Vitamin D.
However, not all Vitamin D products are created equally.

The following is an excerpt from Consumerlab.com:

Incorrect amount of vitamin D or other ingredients
    •    DEVA Vegan Vitamin D 800 IU contained only 664 IU of its listed 800 IU of vitamin D2 per tablet.
    •    Kirkman Calcium/Magnesium Liquid contained its listed amount of calcium but only 18 IU of its listed 41 IU of vitamin D3 per 10 mL serving.
    •    vitafusion Vitamin D3 contained only 317 IU of vitamin D3 per 2 gummy bear serving 31.7% of the listed 1,000 IU.
    •    Li'l Critters Calcium Gummy Bears with Vitamin D, a childrens product, contained much more vitamin D2than listed. A two gummy suggested serving contained 501 IU of vitamin D2, 251% of the claimed 200 IU of vitamin D.
    •    DaVinci Laboratories of Vermont Vitamin K2 Plus contained its listed amount of vitamin D but only 36.8 mcg of its listed 50 mcg of vitamin K2 per capsule.  (A similar deficiency was found in this product when tested in 2009 when ConsumerLab.com reported finding only 63.4% of the claimed amount of vitamin K2.)

Lead contamination
    •    AlgaeCal Plus contained 3.9 mcg and 5.2 mcg of lead, respectively, in suggested servings of 3 and 4 capsules.
    •    Pure Essence Labs Ionic-Fizz Super D-K Calcium Plus contained 2.1 to 4.1 mcg of lead, respectively, in suggested servings of 1 to 2 scoops of powder per day.

Lead contamination is a known potential issue with dietary supplements, particularly those containing minerals or herbal ingredients. AlgaeCal included algae-based calcium and magnesium, while Pure Essence included many minerals and botanical ingredients. Children are most sensitive to lead poisoning and may be affected by total daily exposure to as little as 6 mcg (including all food and drink, as well as supplements). Adults can tolerate higher levels of lead (25 to 75 mcg of lead per day).  Lead is stored in the body and unnecessary exposure should be avoided. The FDA permits supplement manufacturers to set their own limits on lead in their products, but one state, California, requires a warning label on supplements that contain more than 0.5 mcg of lead per daily serving (or 1.5 mcg of lead in supplements that contain 1,000 mg or more of calcium). Neither of the two products with lead contamination had this warning label.

Labeling infractions
    •    Nature's Life D-2 listed potential benefits of vitamin D but did not provide the required FDA disclaimer for such claims. The disclaimer should read: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. This product did, however, meet the other quality criteria of this Review.
    •    AlgaeCal Plus, Pure Essence Labs Ionic-Fizz Super D-K Calcium Plus, and DaVinci Laboratories of Vermont Vitamin K2 Plus (all of which are noted above for other problems) did not provide the required food allergen disclosure for people with sensitivity to soy. The vitamin K in these products is MK-7, which is produced from natto, a fermented soybean. Neither product stated that they contained soy. Other products with MK-7 provided the proper disclosure of their soy content.

Kaizen Kwote of the Day

"Habit is habit, and not to be flung out of the window by anyone, but coaxed downstairs a step at a time."               Mark Twain

Are there any benefits and side effects to taking DHEA? This is a reprint form the Prescriber’s Letter (Anti-aging effects of DHEA. Pharmacist's Letter/Prescriber's Letter 2006;22(12):221208.)

Commentary
DHEA has been studied in doses ranging from 50 mg to 1600 mg per dose, administered as a single dose or as continuous daily doses for up to one year with mixed results on the primary outcomes used in this study.Although short-term benefits can't be ruled out, the present study suggests that long-term anti-aging benefits aren't likely [Evidence level A; high-quality RCT].2
The combined result seen from men and women taking DHEA showed a slight but statistically significant increase in fat-free mass. The importance of this is probably minimal as there was no difference in measured fitness, thigh-muscle area, or strength in the treatment groups compared to those taking placebo.2 While DHEA had some positive benefit on Bone Mineral Density the evidence is too preliminary to recommend its use for osteoporosis in elderly patients. DHEA's effect on BMD was very small in comparison to standard osteoporosis therapies (e.g., bisphosphonates) which have not only been shown to increase BMD, but to decrease fracture risk as well.
DHEA supplementation has been studied for other conditions, such as adrenal insufficiency (25 mg to 50 mg daily), aging skin, erectile dysfunction (50 mg daily), menopausal symptoms (25 mg to 50 mg daily), osteoporosis (50 mg to 100 mg daily), schizophrenia (25 mg to 100 mg daily), and systemic lupus erythematosus or SLE (100 mg to 600 mg daily) with some success.1,5 In 2000, Genelabs Technologies, Inc. submitted an NDA for the approval of DHEA (prasterone [Prestara]). Initial research focused on improving disease activity and symptoms in women with SLE. Based on placebo-controlled trials, orphan drug status has been granted for prevention of BMD loss in patients with SLE taking glucocorticoids. More Phase III trials are required for approval for prevention of BMD loss and treatment of SLE.3
Side effects associated with DHEA in lower doses (50 mg to 75 mg per day) are typically mild. At doses of 200 mg per day, DHEA frequently causes adverse effects.1 DHEA may cause acne in one-third to over one-half of women at doses used for SLE.5 It can also cause gynecomastia in men6 and lower HDL cholesterol in both men and women.7 Growth of facial and body hair, hair loss, voice deepening, insulin resistance, changes in menstrual pattern, hepatic dysfunction, abdominal pain, and hypertension may also occur. There are case reports of mania occurring in patients taking 50 mg to 300 mg of DHEA daily.1
There is also the question of long-term safety with supplemental use of DHEA and the potential to cause prostate or breast cancer. In the present study, although changes in prostate volume and PSA levels did not differ between treatment and placebo groups, two years may be insufficient to detect adverse effects on the prostate.2 And, whether long-term administration of DHEA will uncover detrimental effects such as those found with estrogen remains unknown.3,4
The current status of DHEA as a supplement means there is no FDA requirement for the composition of the oral dosage form. As a result, commercially available DHEA preparations contain from 0% to 150% of the amount stated on the package.1,4
Whether or not DHEA is safe or increases cancer risk when used for longer than two years is not known and long-term anti-aging benefits have not been proven.1,2  
As always, please let us know if you are taking any supplements or medications prescribed from other doctors.

There has been a lot of buzz recently about vitamins in the press. This is the result of new studies showing bad outcomes in women ages 55-69 taking different vitamins and supplements. We have known for years that Vitamin E not only has no cardiovascular benefits, but actually increases the risk of heart disease. We also know that women who take greater then 900 mg of calcium/day are also at risk of heart disease (especially if taken on an empty stomach). The other day, I posted a blog stating that even the “B” vitamins can increase the risk of death. We can also add zinc, magnesium, iron and copper supplements to this list. Several years ago, beta-carotene was being investigated as a preventive treatment for lung cancer, but the study had to be stopped because it actually increased the risk of cancer in smokers.

The bottom line is that you should not rely on vitamins and supplements for your health. There are no substitutes for a diet consisting of lean protein, whole grains and fruits and vegetables.
 
For more information, schedule a consultation with our nutritionist at 941-556-7788

This is a reprint from Prescribers’ Letter, a professional newsletter that accepts no advertising:
For more information, please contact our personal trainers and nutritionists.
www.kaizentotalwellness.com
941-556-7788
 
RUMOR: Certain supplements are safe and proven to enhance athletic performance.

TRUTH: This is mostly false.
Performance enhancing supplements are big business. These products may have some minor effects...but none is going to make big performance differences and there are safety concerns.
The products are touted to build muscle, increase energy, improve endurance, etc...but have little evidence to support these claims.
And there are red flags. For example, the makers of Jack3d won’t even say how much of each ingredient it contains.
Creatine is promoted to increase muscle mass...but it increases size by causing water retention, not adding muscle.
It may help with brief, high-intensity exercise, such as sprinting, power lifting, etc. But it isn’t going to make you the next Mr. or Ms. Olympia.
Warn that doses over 2 g/day are potentially harmful to the kidneys.
Amino acids are often pushed by trainers. But there’s no evidence that they improve performance...or that they increase lean body weight any more than ordinary food does.
Caffeine is used as a stimulant...and it MAY increase endurance and time to exhaustion. But emphasize the importance of keeping track of daily doses. Doses over 250 to 300 mg/day can cause problems...insomnia, stomach upset, tachycardia, nervousness, and diuresis.
And for those in competition, explain that it takes only 800 mg of caffeine to fail a National Collegiate Athletic Association (NCAA) drug test.
Make sure patients count energy “shots” such as 5-Hour Energy or Spike Double Shot. They contain 100 to 350 mg of caffeine per bottle.
And tell patients to consider “hidden” caffeine...guarana, cola nuts, coffee beans, and mate leaves. They’ll be listed as ingredients...but not counted in the caffeine content.
Dimethylamylamine is another stimulant...but there’s no evidence that it helps athletic performance. And it can cause additive cardiac toxicity when used with other stimulants...ADHD meds (methylphenidate, etc), pseudoephedrine, caffeine, etc.
Warn that it’s related to amphetamine, so it can cause false positive drug tests. Plus it’s banned by the World Anti-Doping Agency.
Recommend avoiding the stimulant bitter orange. It replaced ma huang (ephedra) after it was removed from the market for safety issues. But bitter orange is not safe...it’s been linked to stroke, heart attack, arrhythmias, and death.
Look for other names for bitter orange, such as aurantium, aurantii fructus, zhi shi, orange peel extract, etc.
Also recommend avoiding DHEA. It’s not proven to improve muscle mass or strength...but can increase estrogen and testosterone levels.

www.kaizentotalwellness.com   (941)556-7788
www.drmishner.com   (941)747-2090

"CocoaVia and Cirku are new supplements used for high blood pressure and cardiovascular health. They are flavored powders that can be added to a beverage. Each packet contains a cocoa extract providing 350 mg of cocoa flavanols. Research on cocoa flavanols for heart disease is promising. Some research shows that consuming 213-500 mg/day of cocoa flavanols can decrease systolic blood pressure by about 5 mmHg and diastolic by about 3 mmHg. Increasing cocoa intake is also associated with reduced risk of cardiovascular and all-cause mortality.”

From a physician's point of view:
Sounds promising plus natural: Only problem is, most patients need at least a 10-20 point drop in their systolic (top number) to reach goal, And this is for MILD hypertension. Moderate HBP would not only require a 20+ point drop in pressure but usually requires two or more medications. I don’t know how much these supplements cost, but generic lisinopril cost $4/month even without insurance, has been on the market for 25 years and has a great safety profile.

www.drmishner.com   941-747-2090
www.kaizentotalwellness.com   941-556-7788

Osteoporosis is a disease that affects younger as well as older women (men, too!). The biggest risk appears to be genetic, although if you are fair skinned smoke, drinks colas,and petite your are more prone to get it.

The problem with treating this stems from the fact, like hypertension, your first experience with the disease may be when you break a bone. The time to treat it is to when it is diagnosed at an asymptomatic stage.

Calcium, Magnesium and vitamin D are very important supplements to take. However, weight bearing exercise is equally important. In our practice we see many patients who have been on medications for years and do not show significant improvement in their bone density. Luckily, there are new medications on the market that treat resistant osteoporosis, but they are expensive and by injection only.

At Kaizen Total Wellness, we have been amazed by the improvement of bone density with our low impact weight resistance programs ( with and without the use of prescriptions)

Working with our trainers in our office for 30 minutes twice a week (on our low-impact Power Plate and bioDensity machines) in addition to walking or biking the other days can do wonders for your bones.

The next time you see a 70 year old women 4’10”, please be aware that 10 years earlier she was probably 5’2” or greater and asymptomatic.

For more information, please call Kaizen Total Wellness, (941)556-7788.  Please note that all programs are private one on one encounters with our certified fitness trainers and physical therapists. Most insurances accepted.

www.kaizentotalwellness.com / www.drmishner.com

A 14 year old girl may need a corneal transplant after buying and wearing $20 colored contact lens.

Federal law prohibits the sale of contacts without a prescription. However beauty shops and street vendors sell them to customers very inexpensively for cosmetic purposes.

So, what does this have to do with Kaizen Total Wellness and our adult patients?

Beware what you buy without FDA approval-from supplements to vitamins, even internet prescriptions.

www.kaizentotalwellness.com / www.drmishner.com