Updates on Consumer Lab

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alpha betic —* In an email to CL on 6/20/11, Enzymatic Therapy, Inc. the

manufacturer of *alpha betic*, commented that CL’s finding that *alpha betic

* tablets did not disintegrate within the USP requirement of 30 minutes for

regular tablets is an intentional characteristic of the product and meant to

prolong the period over which the nutrients are released. Enzymatic noted

that its own tests have confirmed this “controlled” release over a 5 hour

period. While this may be the case, the product is not clearly marked as

extended release. The Supplement Facts panel for the product simply

describes “tablets” and not “extended release tablets.” In addition, dietary

supplements are required to list all ingredients that may be used as an

extended-release coating among their inactive ingredients. An example would

be hydroxypropyl methylcellulose. *Alpha betic* does not list any such

ingredients. It does list “modified cellulose” but this typically refers to

croscarmellose sodium, which is not an extended release excipient. While the

*alpha betic* bottle claims “Plus Extended Energy,” this does not make it

clear that the tablets are extended release, nor does the claim on a side

panel on the product’s box which states " controlled-release for energy

throughout the day " and refers to some but not all of the product’s

nutrients.

Enzymatic Therapy also commented that although the amount of calcium CL

found (21.1 mg) is slightly lower than claimed the labeled amount (24 mg),

the labeled amount was only an “approximation.” Enzymatic wrote that “At 2%

of the DV the product is clearly not designed to supplement the consumer’s

diet with Calcium. However, the labeling regulations require that we label

Calcium if it is present at 2% or more of the DV. The small amount of

calcium in this product is coming from the carrier (dicalcium phosphate)

utilized in the triturations of Biotin, Vitamin B12, Selenium and Vanadium.”

CL notes that under cGMPs, manufacturers are responsible for verifying label

claims in finished products whenever a valid method is available, as is the

case with calcium. If the amount is variable, then a level at the lower end

of what is expected should be listed.

*Juice Plus+ Garden Blend* – On 6/23/11, ConsumerLab.com was informed of

misinformation circulated by a Juice Plus distributor regarding CL’s testing

of *Juice Plus* which, as noted in the report below, was found to contain

only 76.4% of the listed calcium. The distributor incorrectly stated, “The

variation they report could be the result of the analytical method utilized.

[CL] will not divulge what analytical methods were utilized or what lot

number of a product they tested.” To the contrary, the analytical method

is posted in the How Products Were Evaluated

<https://www.consumerlab.com/howtested/review_multivitamin_compare/multivitamins\

/>section

of this Review and, in fact, is posted free to the public for every

Review<https://www.consumerlab.com/methods_index.asp>.

In this case, the method used was ICP-MS (Inductively Coupled Plasma-Mass

Spectroscopy<http://en.wikipedia.org/wiki/Inductively_coupled_plasma_mass_spectr\

ometry>)

a highly precise and sensitive method for testing calcium. Furthermore, the

calcium deficiency in *Juice Plus* was confirmed with this method in two

independent laboratories prior to publication of the Review. In addition we do

share the lot numbers <https://www.consumerlab.com/aboutcl.asp#policy>of

tested products if requested by the manufacturer or distributor of a

product. In this case, the lot was N100602120. However, no one has contacted

CL for this information.

The Juice Plus distributor also incorrectly wrote of CL that “the majority

of their income is from industry ‘memberships’ rather than consumer

subscriptions. The member companies are given advance notice if any of their

products do not pass testing and are allowed to submit new product for

testing, so completely avoid any public embarrassment.” This is incorrect.

The majority of CL’s revenue is generated by individual subscriptions. We

also offer institutional and group

subscriptions<http://www.consumerlab.com/contact.asp#group>,

which provide the same level of access to our online content that individual

members receive. There are no “corporate memberships” to ConsumerLab.com, no

advance notice of test results of products we have selected for testing, or

any opportunity to suppress those results or substitute a different product.

Companies wishing to have the quality of a specific product tested may do so

through our Voluntary Certification

Program<https://www.consumerlab.com/aboutcl.asp#voluntary>

..

*Melaleuca Vitality Multivitamin & Mineral Men* – (6/28/2011)

ConsumerLab.com was informed by an individual who is a Melaleuca Marketing

Executive (i.e., an independent distributor) of potentially misleading

information being provided by Melaleuca regarding CL’s findings for

the *Vitality

*product. As reported below, CL found this product to contain only 41.7% of

its listed vitamin A, which is listed on the label as coming from

beta-carotene. This deficiency was confirmed in three independent

laboratories prior to publication, each using High Performance Liquid

Chromatography

(HPLC)<http://en.wikipedia.org/wiki/High-performance_liquid_chromatography>which

specifically identifies beta carotene with vitamin A activity.

Melaleuca is apparently distributing test results based upon a USP UV

testing method which is non-specific, i.e., it can overestimate the amount

of vitamin A activity in a finished product. Based on such testing,

Melaleuca claims the same product contains 100% or more of its listed

vitamin A. CL has suggested that Melaleuca use an appropriate HPLC method

for vitamin A determination in finished products.

In addition, Melaleuca test results are apparently based on a batch sample

stored by its manufacturer rather than a product that has gone through

distribution. CL purchased the *Vitality* product from a chiropractic

wellness center that had advertised the product online. Several bottles were

purchased, all having the expiration date of 07/2012 and intact safety

seals. Melaleuca has suggested to CL that the product may have been

mishandled and that CL should have purchased the product directly from

Melaleuca. If Melaleuca products are only to be purchased this way, or have

specific storage and transportation requirements, CL suggests that Melaleuca

actively inform consumers of these requirements. CL found several websites

selling Melaleuca products and the *Vitality* label only states “NOT FOR

RESALE IN CANADA.” CL also suggests that Melaleuca test the product for

stability to ensure potency through its printed expiration date. This is a

FDA requirement for any supplement bearing an expiration date.

During evaluation of the product by CL, it appeared that the product

contained beta carotene in the form of beadlets. Consequently,

ConsumerLab.com used extraction techniques to obtain the beta-carotene from

the beadlets. Melaleuca has confirmed that beadlets are used but indicated

that the extraction method used by CL is not appropriate. However, despite

several requests from CL, Melaleuca has not disclosed to CL what extraction

method it considers appropriate.

CL has offered Melaleuca, per CL’s

policy<http://www.consumerlab.com/aboutcl.asp#policy>,

the opportunity to have the product re-tested. CL has retained and properly

stored an unopened bottle of the product and is prepared to send, at its own

cost, a sample to a third party laboratory for testing using mutually agreed

upon methods, provided that Melaleuca will publicly release and publish the

findings, as will CL. Melaleuca has not, as of yet, taken CL up on this

re-testing offer.

--

Ortiz, MS, RD

*The FRUGAL Dietitian* <http://www.thefrugaldietitian.com>

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