Solal’s Prostrate Protection Formula – Scam?

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Posted 26 July 2013

Breast protectionSolal’s Prostrate Protection Formula claims:

Protects and improves symptoms of enlarged prostate. The only formulation that combines all natural extracts at the correct doses, proven to provide maximum protection for the prostate. I3C, DIM and curcumin extract protect against and may retard the growth of tumour prostate cell mutations“, and,

Beta-sitosterol improves urinary symptoms such as urinary output and bladder emptying. It also inhibits 5-alpha-reductase, thereby preventing the formation of DHT (dihydrotestosterone), a known risk factor for prostate cell mutation and growth. Pygeum africanum extract prevents prostate inflammation, cell proliferation and growth. Lycopene and selenium reduce the risk of prostate cell mutations.http://www.solal.co.za/prostate-protection-formula

Note the  statement “Lycopene and selenium reduce the risk of prostate cell mutations.

What is the evidence in support that lycopene and/or selenium will be beneficial for the prostrate? Nil actually.

 

Below are two of the latest scientific reviews and a UK Advertising Standards ruling against a lycopene product – sadly, Solal have again utilised pseudoscience by claiming “[L]ycopene and selenium reduce the risk of prostate cell mutations” – unless this product’s target market is rats or mice, where these claims may be true. 

[1] “However, there is still no clearly proven clinical evidence supporting the use of lycopene in the prevention or treatment of prostate cancer . . .

[2] “The role of lycopene, an open-chain carotenoid found in tomatoes and devoid of retinoid activity, as an anticarcinogenic, chemopreventive agent, especially for use in prostate cancer, is still under active investigation“,

and,

In this issue, Qui and colleagues show that lycopene induces responses in human prostate epithelial cells that are antiproliferative, antioxidative, and anti-inflammatory, as well as downregulating targets in the androgen receptor signaling pathway. In this perspective, we review aspects of the molecular and cellular biology of lycopene that support its use for prevention of prostate cancer. Whether lycopene itself or its metabolites induce most of its benefits is still uncertain. At present, meta-analysis of clinical studies of lycopene for prevention of prostate cancer in men does not yet support the definitive clinical use of this carotenoid in a preventive setting.

References: 

  1. Int J Mol Sci. 2013 Jul 12;14(7):14620-46. doi: 10.3390/ijms140714620. The potential role of lycopene for the prevention and therapy of prostate cancer: from molecular mechanisms to clinical evidence. Holzapfel NP, Holzapfel BM, Champ S, Feldthusen J, Clements J, Hutmacher DW. http://www.ncbi.nlm.nih.gov/pubmed/23857058
  2. Cancer Prev Res (Phila). 2013 May;6(5):384-6. doi: 10.1158/1940-6207.CAPR-13-0026. Epub 2013 Mar 12. Is lycopene an effective agent for preventing prostate cancer? Sporn MB, Liby KT. http://www.ncbi.nlm.nih.gov/pubmed/23483003

 

 

Recent research on selenium

“At present, selenium is not identified to be effective to the primary prevention of prostate cancer, and the selenium supplementation is not recommended to the men risky to prostate cancer clinically.” [1] 

“This randomized, double-blind, placebo-controlled, 2 × 2 factorial design clinical trial found that neither selenium nor vitamin E reduced the incidence of prostate cancer after seven years and that vitamin E was associated with a 17% increased risk of prostate cancer compared to placebo. The null result was surprising given the strong preclinical and clinical evidence suggesting chemopreventive activity of selenium.” [2] [3] 

References: 

  1. Asian Pac J Cancer Prev. 2013;14(4):2181-4. Review of selenium and prostate cancer prevention. Yang L, Pascal M, Wu XH. http://www.ncbi.nlm.nih.gov/pubmed/23725109
  2. Semin Oncol. 2013 Jun;40(3):276-85. doi: 10.1053/j.seminoncol.2013.04.003. Prostate cancer chemoprevention. Sandhu GS, Nepple KG, Tanagho YS, Andriole GL. http://www.ncbi.nlm.nih.gov/pubmed/23806493
  3. Nutrients. 2013 Apr 3;5(4):1122-48. doi: 10.3390/nu5041122. Selenium and prostate cancer prevention: insights from the selenium and vitamin E cancer prevention trial (SELECT). Nicastro HL, Dunn BK. http://www.ncbi.nlm.nih.gov/pubmed/23552052

 

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ASA Adjudication on Direct Healthcare Ltd Direct Healthcare Ltd t/a Chemist Direct

Date:  24 July 2013 

Complaint Ref: A13-229497

Background 

Summary of Council decision: 

Five issues were investigated all of which were Upheld.

Ad 

A website, www.chemistdirect.co.uk, for Ateronon Tomato Pills, a lycopene-based food supplement, featured text which stated “Tomatomax Pure High Strength Tomato Extract … TomatoMaxT lycopene supplement is extremely rich in antioxidants and phyto-nutrients which can help to reduce the risk of cardiovascular disease …”. Further text stated “Tomatoes contain high levels of Lycopene which have been linked to a reduction in cholesterol levels and support heart health”.

 

Text beneath the subheading “How Does TomatoMaxT Work? The Science Behind The Secret …” stated “Packed full of phyto-nutrients, Bioconcepts TomatoMaxT is a powerful, all-natural antioxidant found to be beneficial to heart health … The formulation of TomatoMaxT is made from non-GMO tomatoes that have been specifically selected for their high levels of Lycopene. The extraction process ensures the tomatoes are high quality, super strength and rich in a range of active tomato phytonutrients. Lycopene is well documented for its cardiovascular system health benefits and has also been seen to be beneficial for sufferers of exercise induced asthma, preeclampsia, prostate cancer and sunburn.

Issue 

The complainant challenged whether the following claims were authorised health claims on the EU Register: 

1. “Tomatoes contain high levels of Lycopene which … support heart health”; 

2. “Lycopene is well documented for its cardiovascular system health benefits and has also been seen to be beneficial for sufferers of … sunburn.”; and 

3. “TomatoMaxT lycopene supplement is extremely rich in antioxidants”. 

The complainant also challenged whether the following Reduction of Disease Risk claims were authorised by the EU Commission and met the conditions of use associated with the relevant claim: 

4. “Tomatoes contain high levels of Lycopene which have been linked to a reduction in cholesterol levels”; and 

5. “Lycopene is well documented for its cardiovascular system health benefits and has also been seen to be beneficial for sufferers of exercise induced asthma, preeclampsia, prostate cancer”.

CAP Code (Edition 12)

15.1

15.1.1

15.6.2

15.7

Response 

Direct Healthcare Ltd t/a Chemist Direct (Chemist Direct) acknowledged that the claims breached the Code and said they had removed the claims.

Assessment 

1., 2., 3., 4., & 5. Upheld 

The ASA considered the claims “Tomatoes contain high levels of Lycopene which … support heart health”, “Lycopene is well documented for its cardiovascular system health benefits and has also been seen to be beneficial for sufferers of … sunburn” and “TomatoMaxT lycopene supplement is extremely rich in antioxidants” were health claims, i.e. claims that stated, suggested or implied that a relationship existed between a food category, a food or one of its constituents and health. We considered the claims “Tomatoes contain high levels of Lycopene which have been linked to a reduction in cholesterol levels” and “Lycopene is well documented for its cardiovascular system health benefits” were reduction of disease-risk claims, i.e. claims that stated, suggested or implied that the consumption of a food category, a food or one of its constituents significantly reduced a risk factor in the development of a human disease. We also considered the claim “Lycopene … has also been seen to be beneficial for sufferers of exercise induced asthma, preeclampsia, prostate cancer” was a claim to treat or cure disease and was therefore not acceptable under CAP Code rule 15.6.2. 

Health claims and reduction of disease risk claims were only acceptable under the CAP Code if they were listed as authorised in the EU Register of nutrition and health claims. Because we had not seen evidence that the claims were authorised by the European Commission, we concluded that they breached the Code. 

The ad breached CAP Code (Edition 12) rules 15.1, 15.1.1, 15.6.2, 15.7 (Food, food supplements and associated health and nutrition claims).

Action 

The ad must not appear again in its current form. We told Chemist Direct not to make health claims or reduction of disease risk claims for foods if they were not listed as authorised in the EU Register.

 

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