Deceptive marketing of Stem Enhance / StemEnhance

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Posted 04 February 2015

FDA Advisory No. 2013-025
DECEPTIVE ON-LINE SALE AND MARKETING OF STEM ENHANCE TM PRODUCT

http://www.fda.gov.ph/advisories/pharmaceutical/98391-fda-advisory-no-2013-025

The Food and Drug Administration has monitored the product STEM ENHANCETM that is being promoted and sold on-line and dubiously labeled as a Dietary Supplement that Supports the Natural Release of Adult Stem Cells, manufactured by STEMTech Health Sciences. Inc. of Klamath Falls, Oregon, USA. This product is not registered by the FDA (http://www.fda.gov.ph/consumers-corner/registered-food-supplements/8732-fr-100019).

Based on FDA records, a similar product, StemEnhance AFA Extract Food Supplement, was granted registration by the FDA, labeled as a food supplement with “No
Approved Therapeutic Claims”. This is different from the one shown in the picture.

The consumers are hereby warned that STEM ENHANCETM has no curative value. No clinical studies or scientific justification has been shown to substantiate the claim that it can release adult stem cells from bone marrow into circulation. The health claim is deceitful and fallacious.

Considering that STEM ENHANCETM is not registered with the FDA, and its safety and health claims have not been evaluated by the FDA, the public is hereby warned not to use and patronize the on-line sale of the said product.

The case is now under investigation.

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One Response to Deceptive marketing of Stem Enhance / StemEnhance

  1. Worms'n'Algae 17 March, 2015 at 5:22 am #

    I follow the Klamath Blue Green Algae news as I lived there for a long time and knew many people involved in Cell Tech and the following companies such as StemTech. A study was published (paid for by StemTech) last year which found no difference between their StemSport (which has the algae as well as earthworm extract) and a placebo. Did they pull it from the market? Nah, they just ignore the study, or perhaps say ‘there have been several studies done of our ingredients.’ Here’s the PubMed link: http://www.ncbi.nlm.nih.gov/pubmed/24910543

    And abstract:
    J Int Soc Sports Nutr. 2014 May 28;11:23. doi: 10.1186/1550-2783-11-23. eCollection 2014.
    Effect of an herbal/botanical supplement on strength, balance, and muscle function following 12-weeks of resistance training: a placebo controlled study.
    Furlong J1, Rynders CA2, Sutherlin M1, Patrie J1, Katch FI1, Hertel J1, Weltman A1.
    Author information
    Abstract
    BACKGROUND:
    StemSport (SS; StemTech International, Inc. San Clemente, CA) contains a proprietary blend of the botanical Aphanizomenon flos-aquae and several herbal antioxidant and anti-inflammatory substances. SS has been purported to accelerate tissue repair and restore muscle function following resistance exercise. Here, we examine the effects of SS supplementation on strength adaptations resulting from a 12-week resistance training program in healthy young adults.
    METHODS:
    Twenty-four young adults (16 males, 8 females, mean age = 20.5 ± 1.9 years, mass = 70.9 ± 11.9 kg, stature = 176.6 ± 9.9 cm) completed the twelve week training program. The study design was a double-blind, placebo controlled parallel group trial. Subjects either received placebo or StemSport supplement (SS; mg/day) during the training. 1-RM bench press, 1-RM leg press, vertical jump height, balance (star excursion and center of mass excursion), isokinetic strength (elbow and knee flexion/extension) and perception of recovery were measured at baseline and following the 12-week training intervention.
    RESULTS:
    Resistance training increased 1-RM strength (p < 0.008), vertical jump height (p < 0.03), and isokinetic strength (p 0.10).
    CONCLUSIONS:
    These data suggest that compared to placebo, the SS herbal/botanical supplement did not enhance training induced adaptations to strength, balance, and muscle function above strength training alone.
    KEYWORDS:
    Anti-oxidant; Blue-green Algae; Strength exercise

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