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U.S. Department of Health and Human Services

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Nature's Health Supply 7/15/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415

 

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED                                                           
 
 
WARNING LETTER
 
 
July 15, 2013
 
WL # 46 - 13
                                                                                                                                                 
Eric Sclar
Nature’s Health Supply, Inc
1752 Via Aracena
Camarillo, CA 93010
 
 
Dear Mr. Sclar,
 
 
This is to advise you that the Food and Drug Administration (FDA) has reviewed your websites at the Internet addresses http://www.diabetes-daily-care.com, http://www.prostate-miracle.com, http://www.estrogen-balance.com, http://www.cholesterol-metabolizer.com, http://www.pectin-plus.com, http://www.vitamin-d-max.com, http://www.immune-system-plus.com, http://www.coral-calcium-supply.com, http://www.sea-veg.info, and http://barleygreensupply.com, in May 2013 and has determined that you take orders there for the products, “Diabetes Daily Care,” “Prostate Miracle,” “Estrogen Balance,” “Cholesterol Metabolizer,” “Pectin Plus,” “D Max,” “Immune System Plus,” “Coral Calcium,” “Super Sea Veg,” and “Barley Green Premium,” which the websites promote for conditions that cause the products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your web sites establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of a disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
http://www.diabetes-daily-care.com
 
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.” 
 
“[A]lthough Diabetes Daily Care® does note “cure” diabetes, it is very effective in managing and controlling diabetes; … we consider it a treatment…”
 
 “There are 3 components to a natural diabetes cure: … Nutritional Supplements … These supplements are very effective in helping to lower blood sugar and insulin levels, reduce cholesterol levels …reduce blood pressure … and reduce the risk of heart disease.”
 
“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 …”
 
“Cinnamon [an ingredient in your product] . . . it has demonstrated great medical application in preventing and combating diabetes . . . Cinnamon plays the role of an insulin substitute in type II diabetes.”
 
“All three of the groups given cinnamon showed reduced blood sugar levels.”
 
“Collectively, all three levels of cinnamon resulted in:
 
o   “Reduced blood sugar levels by 18-29%”
o   “ Reduced LDL cholesterol by 7-27%”
o   “ Reduced total cholesterol by 12-26%”
 
“Even the group with the lowest amount of cinnamon (1 gram per day),
produced an approximately 20% drop in blood sugar.”
 
“When daily cinnamon was stopped, blood sugar levels began to increase.”
 
“Including cinnamon in the diet of people with type 2 diabetes will reduce risk factors associated with diabetes and cardiovascular disease.”
 
“ALA [an ingredient in your product] inhibits glycosylation … of nervous tissues … it has been used to improve diabetic nerve damage and reduce pain associated with that nerve damage.”
 
“[S]upplementing with ALA can partly restore diabetic nerve function after only four months of high-dose oral treatment.”
 
“ALA … is particularly suited to the prevention and/or treatment of diabetic complications . . .”
 
“ALA . . . increases glucose disposal in type 2 diabetics and markedly reduces the symptoms of diabetic pathologies, including cataract formation, vascular damage and polyneuropathy.”
 
“[C]hromium [an ingredient in your product] supplements can help both Type 1 and Type 2 diabetics control their blood sugar.” 
 
“Favorable results are seen, as well, in animal models of insulin deficiency, where vanadium [an ingredient in your product] significantly reduces blood glucose levels, and in insulin-resistant diabetic animals…”
 
“[V}anadium compounds produce significant, sustained decreases in …blood pressure.”
 
“Clinical trials with vanadium compounds have produced benefits in both type 1 and type 2 diabetic patients. Results have been better, however, in type 2 patients.  Six type 2 diabetic subjects treated with 100 milligrams of vanadyl sulfate daily for four weeks had significant reductions in fasting plasma glucose….”
 
“Banaba Leaf Extract [an ingredient in your product] provides a blood sugar lowering effect...”
 
“[A]dministration of banaba leaf extract resulted in a significant decrease of blood glucose.”
 
“In noninsulin-dependent animals, administration of banaba leaf extract resulted in suppressed blood plasma glucose… and lower urinary excretion of glucose.”
 
“[A] one per cent corosolic acid of banaba leaf reportedly reduced serum glucose 20-30% in people with type 2 diabetes…”
 
“Among the constituents in bitter melon [an ingredient in your product], charantin is identified as a primary agent for blood-sugar regulation. Charantin demonstrates hypoglycaemic (blood sugar lowering) or other action of potential benefit in diabetes.”
 
“[S]everal substances in bitter melon contribute to its blood sugar-modifying effects. In human studies, bitter melon demonstrates … overall blood sugar-lowering effects.”
 
“When taken internally, it [gymnema sylvestra, an ingredient in your product] helps to control blood-sugar levels in diabetes.”
 
The leaves of Gymnema sylvestre perform two significant functions relative to diabetes.”
 
“Gymnema sylvestre proves a valuable aid in diabetes control.”
 
“Gymnema lowers blood sugar levels in Type 1 and Type 2 diabetics.”
 
“[A]ntidiabetic properties of fenugreek.”
 
“Today fenugreek shows value as an antidiabetic agent…”
 
“Experimental and clinical studies have demonstrated the antidiabetic properties of fenugreek seeds. The active ingredient responsible for the antidiabetic properties of fenugreek … Modern
research shows that fenugreek seeds not only lower blood glucose but reduce … total cholesterol…”
 
“The vast majority of people who use Diabetes Daily Care® experience substantially reduced blood glucose levels. Most are able to cut back on or totally eliminate the use of prescription drugs with the blessings of their medical doctor. Most experience great improvement in many of the complications that are generally associated with diabetes...”
 
“Many men have also reported … restored sexual function.”
 
“It is very important to note that, because Diabetes Daily Care® may have significantly positive effects on your blood glucose levels . . . your medication needs may change . . . and so your blood sugar and medication levels should be closely monitored.
 
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of “Diabetes Daily Care” for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
 
 “I have had type 2 diabetes for 27 years. … I’ve got to tell you that within the first month of taking Diabetes Daily Care, my feet stopped hurting altogether and I can now walk totally pain free. … I’ve been taking Diabetes Daily Care for six months now and my blood sugar is well within normal range.”
 
 “I have been on Diabetes Daily Care for 2 weeks so far … My blood sugar has averaged 103 over the past two weeks compared to the 160 I was averaging before.”
 
 “I’m type 2 diabetic, who also has high cholesterol … my glucose reading had gone down 32 points and my cholesterol profile had significantly improved as well … I had been taking both Diabetes Daily Care and Cholesterol Metabolizer.”  
 
 “After taking Diabetes Daily Care for one month, I lowered my blood sugar 40 points. … I would highly recommend it to anyone who suffers from diabetes!”
 
 “I have been using Diabetes Daily Care for about 3 weeks now … My average glucose readings have gone from 12.5 - 16 mmol/L to 6 - 8.5 mmol/L/”
 
 “I started using Diabetes Daily Care about 6 months ago after being diagnosed as a type 2 diabetic.   … My sugar stays in the 90 to 105 range as long as I use Diabetes Daily Care on a regular basis.”
 
 “I have been diabetic for 12 years … within 1 month of taking Diabetes Daily Care, my blood sugar levels stabilized between 120 to 125 without any insulin at all!”
 
 “I’ve been using Diabetes Daily Care for about a year and noticed results in a week or two.  My blood sugar dropped about 30 points.”
 
 “I’ve been Diabetic for 9 years now. My doctor’s had me on Glucophage which I was taking 3 times a day to stay somewhere between 140 and 175 points all day. After taking Diabetes Daily Care for 1 week, I noticed that I was able to reduce the Glucophage to 2 times a day and still keep my sugar stabilized below 140 all day. By the end of my first month, I was able to reduce the Glucophage to 1 time per day and stay stable at 109-115. I’ve been on Diabetes Daily Care for 6 months now and I am stable around 90!” 
 
 “[M]y blood sugar was between 325 and 375. [sic] and that I needed to go on insulin. … Since starting Diabetes Daily Care® I’ve been able to maintain my blood sugar at 100 to 120.”
 
 “I’ve been taking Diabetes Daily Care for 3 months and my blood sugar has been steadily coming down from 254 to 131 now.
 
http://www.prostate-miracle.com:
 
 “[O]ur #1 rated, proven Prostate Formula, which has given thousands of men the relief they seek for prostate discomfort.”
 
 “Prostate Miracle® is 95% effective in treating an enlarged prostate.”
 
 “Prostate Miracle® is a Natural, Highly Effective Treatment for BPH”
 
 “[B]eta-sitosterol [an ingredient in your product] is the most effective remedy known for prostate problems.”
 
 “Prostate Miracle® is effective in 95% of patients, significantly decreasing the prostate size while dramatically reducing BPH symptoms.”
 
 “Prostate Miracle® is effective in relieving BPH induced Prostatitis.”
 
 “Prostate Miracle® is effective in lowering PSA levels.”
 
 “Prostate Miracle® is an excellent pre-emptive measure to prevent prostate cancer from developing.”
 
 “Prostate Miracle® May Help Prevent and Slow the Growth of Prostate Cancer.”
 
 “[B]enefit selenium [an ingredient in your product] has in both treating and preventing prostate cancer. In fact is has been demonstratead [sic] that 200 mcg per day of selenium may actually reduce the risk of getting prostate cancer (by as much as 50%).
 
 “The benefit of selenium is not limited to prostate cancer . . . other studies have shown that taking 200 mcg of selenium per day may actually protect against lung cancer & guard against colon cancer as well.
 
Under the heading, “Beta Sitosterol”:
 
 “[B]eta-sitosterol is an extremely effective, natural treatment for an enlarged prostate.”
 
 “[B]eta-sitosterol has a treatment for BPH and other prostate ailments.”
 
 “[H]ave confirmed the efficacy of beta-sitosterol in alleviating the types of prostate discomfort ...” 
 
 “The International Prostate Symptom Scores showed a statistically significant improvement. These results with beta-sitosterol are comparable to those seen with the commonly prescribed drug Proscar®, used to treat benign prostate enlargement.”
 
 “[B]eta-sitosterol improved urinary symptom scores and urinary flow rates … The magnitude of reduction in prostate symptoms and improvement in urinary flow rates is a strong incentive for the use of beta-sitosterol, either alone or in combination with standard pharmacologic
interventions such as alpha-adrenergic blockers (Cardura®, Hytrin®, Uroxatral®, Flomax®) or 5-alpha reductase inhibitors (Proscar®, Avodart®).
 
 “A study using the prostate cancer cell line LNCaP (an androgen dependent tumor) showed that beta-sitosterol decreased cancer cell growth by 24% …”
 
 “Growth of the human prostate cancer PC-3 cell ine (androgen independent) implanted in mice was compared … beta-sitosterol … inhibited the growth of PC-3 cells by 70% ...”
 
 “Europeans use beta-sitosterol by itself or in combination with saw palmetto to alleviate urinary symptoms of benign prostate enlargement.”
 
Under the heading, “FAQ”:
 
 “How does Prostate Miracle® work ? 1) Prostate Miracle® actually reduces the size of the enlargement, thus allowing urine flow to return to normal.”
 
 “Does Prostate Miracle lower the PSA score?  ... Yes it does … and it can reduce the risk of getting prostate cancer by 50%.”
 
 “How long do you need to take Prostate Miracle® for ? Forever . . . If you stop taking it, your prostate will enlarge again.”
 
 “[I]f you have Prostatitis: Estrogen Balance® should be your first choice,”
 
 “[I]f your case of prostatitis is a secondary condition of BPH then Prostate Miracle® would be quite helpful as well.”
 
 “If you have Prostate Cancer; Pectin Plus® should be your first choice, as it inhibits the metastasis of cancer.”
 
http://www.estrogen-balance.com:
 
Beginning at the top of the site:
 
 “Estrogen Balance®
 
· Reduces Enlarged Prostate
· Lowers the risk of Heart Attacks
· Lowers the risk of Cancer
  
  “Estrogen Balance supports improved estrogen metabolism leading to an optimal ratio of “good and “bad” estrogen metabolites, which results in a greatly reduced risk of getting cancer …”
 
Under the heading “DIM”:
 
 “D.I.M … providing the following health benefits:  protects against heart disease … protects against cancer … ”
 
 “D.I.M. is beneficial for women dealing with: breast cancer ovarian cancer, uterine cancer, uterine fibroid tumors … cervical dysplasia, and SLE (systemic lupus erythematosis). D.I.M. is highly recommended for women on HRT (hormone replacement therapy) or at risk for breast cancer …”
 
Under the heading “Quercetin”:
 
 “Quercetin has anti-estrogenic effects which lead to reduced risk of certain cancers … inhibiting the growth of breast cancer cells in a test tube. Quercetin has also been … shown to have … anti-inflammatory and antimicrobial properties. In fact it may be the strongest of natures [sic] anti-inflammatories.” 
 
 “Quercetin has been used in connection with the following conditions:
 
1.   Prostatitis (nonbacterial prostatitis, prostadynia)
2.   Allergies
3.   Asthma
4.   Atherosclerosis
6.   Cataracts
7.   Childhood diseases
8.   Diabetes
9.   Edema (water retention)
10. Gout
11. Hay Fever
12. Peptic ulcer
13. Retinopathy”
 
At the bottom of the page where product is ordered:
 
 “Estrogen balance…
 
In Men:
 
o   effective treatment for prostatitis
o   decreases prostate enlargement
o   lowers risk of prostate cancer
o   In Women:
o   lowers risk of breast cancer
o   lowers risk of uterine cancer
 
In Men and Women
 
o   Greatly lowers risk of heart attack”
 
http://www.cholesterol-metabolizer.com:
 
Beginning at the top of the site:
 
 “Lower your Cholesterol naturally with Cholesterol Metabolizer”
 
 “Cholesterol Metabolizer … cholesterol reducing formula which is guaranteed to safely and effectively lower your serum cholesterol level”
 
 “Lowers "bad" Cholesterol”
 
http://www.pectin-plus.com 
 
Under “Pectin-plus and Cancer”:
 
 “Citrus Pectin as a potential cancer therapy … Galactose rich Citrus Pectin … cancer cells find it harder to stick to other cancer cells or to healthy tissues. In short, they are rendered less likely to metastasize. Citrus Pectin has the additional effect of blocking angiogenesis which results in the cancer cells being starved to death.”
 
 Citrus Pectin has been shown to slow PSA doubling time, which could potentially result in the inhibition of cancer metastasis.”
 
Under “Pectin-plus and Cancer”:
 
 “Garlic [an ingredient in your product] is believed to have anti-tumor properties, owings to its content of a wide variety of organic sulfides and polysulfides, which disrupt the metabolism of tumor cells. This inhibition seems to be most effective when the tumor is small. It is theorized that garlic enhances immune function by stimulating lymphocytes and macrophages to destroy cancer cells.”
 
 “[G]arlic can slow the development of bladder, skin, stomach, and colon cancers.”
 
 “[G]arlic destroys H. pylori, the bacteria believed to cause some stomach ulcers and a suspected culprit in stomach cancer.”
 
 “[T]the incidence of stomach cancer is lower in people who eat lots of garlic.”
 
At the bottom of the page where product is ordered:
 
 “Pectin Plus®
 
o   Lowers Cholesterol
o   Inhibits formation of plaque
o   Lowers High Blood Pressure 
 
 http://www.vitamin-d-max.com:
 
 Beginning at the top of the site:
 
 “Vitamin D may play a role in the prevention and/or treatment of the following health conditions:”

 “Atherosclerosis, Heart Disease, Hypertension, Breast cancer, Colon cancer, Skin cancer, Kidney disease, Liver disease, Multiple sclerosis, Muscle Weakness, Chronic Pain, Osteoarthritis, Periodontal disease, Preeclampsia, Psoriasis, Tinnitus, Mental Illness, Depression, Epilepsy, Diabetes, Obesity, Ulcerative colitis, Inflammatory bowel disease.”

 http://www.immune-system-plus.com:
  
 “Immune System Plus™ will enable … killing of the infection before it has a chance to take hold.”
 
 “Immune System Plus™ was formulated to ensure and support our unique abilities to fight infection.”
 
www.coral-calcium-supply.com: 
 
Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of “Coral Calcium” for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
 
 “[M]y husband discovered he had Cancer of the Prostrate [sic] and it had attached to his bones … Instead of having Chemo-therapy my husband made a decision to use Coral Calcium as a supplement. Four weeks after starting on Coral Calcium, my husband returned for a follow up visit to the Doctor. Test[s] were ran at this time and NO CANCER CELLS WERE FOUND.”
 
 “I have been taking Coral Calcium for about 1 ½ months … my cholesterol has come down 67 points …”
 
http://www.sea-veg.info: 
 
Beginning at the top of the site:
 
 “Super Sea Veg contains 531 mcg of organic iodine per 3 capsule serving … This vegetable form of iodine is far superior to potassium iodine when it comes to safely and effectively protecting your thyroid against radiation.”
 
http://www.barleygreensupply.com:
 
Under “Barley Green Premium”:
 
 “[P]revention of arteriosclerosis and reduce inflammation and muscle soreness.” 
 
Further, your websites cite articles regarding the use of your products and some of their ingredients to treat prostate cancer and other prostate related problems. When scientific publications are used commercially by the seller or a product to promote the product to consumers, such publications may become evidence of the product's intended use: For example; under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease.
The following reference citation is an example of the many used to market "Prostate-Miracle" for disease treatment and prevention on your website:

“Berges RR, Kassen A, Senge T. Treatment of symptomatic benign prostatic hyperplasia with beta-sitosterol: an 18-month follow-up. BJU Int. 2000 May;85(7):842-6.”

 
The claims quoted above are supplemented by the metatags used to bring consumers to your websites through Internet searches.
 
For http://www.diabetes-daily-care.com the metatags include:

"diabetes,” “diabetes natural treatment,” “diabetes herbs,” “natural diabetes cure,” and “natural diabetes treatment,”

For http://www.prostate-miracle.com the metatags include:

 “benign prostatic hypertrophy,”

For http://www.cholesterol-metabolizer.com the metatags include:

 “Controlling Cholesterol,” “natural cholesterol cure,”

For http://www.pectin-plus.com the metatags include:

“cancer therapy,” “natural cancer treatment,”

For http://www.coral-calcium-supply.com the metatags include:

“cancer,” “diabetes”

Your products are not generally recognized as safe and effective for the above referenced conditions and therefore, these products are also “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
 
Furthermore, your products “Diabetes Daily Care,” “Prostate Miracle,” “Estrogen Balance,” “Cholesterol Metabolizer,” “Pectin Plus,” “D Max,” “Immune System Plus,” “Coral Calcium,” “Super Sea Veg,” and “Barley Green Premium” are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these drugs are also misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate
 
 
directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
This letter is not intended to be an all-inclusive review of your websites and products your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
 
If you need additional information or have questions concerning any products distributed through your websites, please contact FDA. You may respond in writing to Dr. Raymond W. Brullo at the Food and Drug Administration, Los Angeles District, 19701 Fairchild, Irvine, CA 92612. If you have any questions concerning this letter, please contact Dr. Brullo at (949) 608-2918.
 
 
Sincerely,
/S/ 
Alonza Cruse, Director
Los Angeles District
 
 
Cc        Eric Sclar
            PO Box 271
            Camarillo, CA 93011