supplementstatements
in

Supplements: Company statements

Here's how the brands responded to our investigation.

Cytosport (Muscle Milk)
GNC (GNC Lean Shake 25, GNC Mass IV Pro Performance, Vitamin C)
Jamieson (Red Super Krill, Omega 3 Complete, Vitamin C)
Natural Factors (Natural Factors Maximum Triple Strength Omega-3)
NBTY (Nature’s Bounty Omega 3 Fish Oil, Body Fortress, Ester-C)
Pfizer (Emergen-C)
Swiss Naturals (Vitamin C)
Treehouse Gummies (Omega 3 and Vitamin C)

 

 

STATEMENT FROM CYTOSPORT
(Muscle Milk)

Introduction:

CytoSport, Inc., owner of the MUSCLE MILK® and MUSCLE MLK® brands of products, appreciates the opportunity to respond to the test results for the MUSCLE MLK® protein powder product CBC has presented. Because protein is so central to all MUSCLE MLK® products, CytoSport takes the allegations and test results very seriously. As discussed in more detail below, we strongly believe CBC’s test results are erroneous and reflect either an error at the laboratory or counterfeit product.

Formulation:

The CBC test results do not match, in any way, the formulation of the MUSCLE MLK product CBC had tested. The MUSCLE MLK product formulation does not contain any added free form amino acids. Rather, it is formulated with intact protein sources (Calcium Sodium Caseinate, Milk Protein Isolate and Whey Protein) to include a level of protein that consistently meets and often exceeds the 32g label claim. CytoSport’s Quality Assurance department has retrieved and reviewed the manufacturing documents for the specific lot of product identified by CBC and determined the specific lot was manufactured according to the correct formulation, which included more than 32g of intact protein per serving and no added free form amino acids.

Product Retain and Testing:

In accordance with regulations, CytoSport keeps a jar/bottle (known in the food industry as a product retain) from each lot of product it produces. CytoSport’s Quality Assurance department retrieved the product retain for the lot of product identified by CBC.  Photos of that product retain are attached for this response. CytoSport then sent the product retain with intact seal to Covance, Inc., for testing. For reference, Covance is one of largest, if not the largest, food and pharmaceutical testing laboratory companies in the world. CytoSport requested Covance perform several types of analytical testing of the product retain, including total amino acids, free form amino acids, and total protein (Dumas method). Per CytoSport’s request, Covance has maintained a full chain of custody paperwork throughout its receipt and analysis of the MUSCLE MLK powder product retain. Covance has retained the product retain along with the chain of
custody paperwork so the product retain can be further tested by Covance or another laboratory, as necessary.  The Certificate of Analysis (COA) including those test results is enclosed with this response. Briefly, the Covance testing reveals the product retain contains (a) no measurement
amount of free form amino acids; (b) 34.6 grams of total amino acids per 70g serving; and (c) a total of 32.8 grams of protein per 70g serving, even after adjusting for any non-protein nitrogen sources. In other words, the product retain met and exceeded the label claim for bound protein and with no free form amino acids. A comparison of the Covance test results to the test results obtained by CBC and related analysis follows.

Analysis and Comparison of CBC and Covance Test Results:

The CBC test results provided to CytoSport indicated the following:

  • We measured true protein content of 25.13g per 70g serving. The label claims 32g per serving. This is 21.5% less protein than claimed.
  • We also measured the free amino acid content for this product at 2.17g per serving.
  • After combining free amino acids and bound protein (27.30g per serving), the visible “protein” content via AOAC methods is still 15% below the 32g label claim for protein.

Inconsistencies with the above reported results:

  • The Measured “true protein” result of 25.13g per serving + the “free form amino acid” result 2.17g = 27.3g is inconsistent with the Kjeldahl (nitrogen basis) results of 44g per serving that is reported.  If the Kjeldahl result is in a % format, 44% of a 70g serving would yield 30.8g protein, which is also inconsistent with the 27.3g result.  Typically when we look at amino acid composition and content of bound protein we yield ~10% more amino acids than we do from the Kjeldahl test. This is because the hydrolysis of the protein (part of the process to break down the protein into itsconstituent amino acids) consumes water weight, adding to the total weight of the amino acids/protein. Based on this, we would always expect the total amino acids found through bound protein hydrolysis and free form amino acid assay to total more than the amount we find using Kjeldahl or Dumas nitrogen analysis. Therefore it does not make scientific sense to find 27.3g through the true protein calculation + free form amino acids and then find either 44g or 30.8g from Kjeldahl analysis, since this number should always be lower than 27.3g.
  • The results from Covance show the total amino acid content of the product to be 34.6g by amino acid assay. The Dumas (Nitrogen Analysis) show the protein content to be 32.8g. Both of these number correlate with what is expected with the amino acid total being 5.5% higher for the total amino acid assay vs the Dumas (Nitrogen Analysis).
  • MUSCLE MLK protein powder contains three primary ingredients supplying protein: Calcium Sodium Caseinate, Milk Protein Isolate and Whey Protein, all of which are derived from Milk. As a result, one would expect the amino acid profile of the protein in MUSCLE MLK to closely resemble that found in Milk. The amino acid profile from the CBC test report has several inconsistencies that do not align with what is typically found in milk proteins. Specifically, the analysis showed a non-detect for several amino acids including Tryptophan, Valine, Cystine. These three amino acids are always found in the milk-based protein ingredients that are in MUSCLE MLK. The analysis also showed abnormal amounts of Aspartate, Glutamate, Serine, Histidine, Threonine, Alanine, Alanine, Phenylalanine, Leucine, Lysine, Proline and Tryptophan. To help better outline the differences please see the below table which shows the Amino Acid profile from the CBC test report, the Covance results and those typically found in Milk (from the USDA database).  The Covance results are very similar to the USDA database whereas the CBC results do not resemble the expected results or the typical profile from Milk.

Finally, we note that the MUSCLE MLK® powder product is indeed expired, as it has a “Best By” date of January 16, 2015.  The Best Before code on the product reads “15 JA 16”.  Per the Canadian Food Inspection Agency's guidelines for best before dates (http://www.inspection.gc.ca/food/information-for-consumers/fact-sheets/date-labelling/eng/1332357469487/1332357545633), when the year is included as part of the Best Before date, "the year must appear first, followed by the month, then by the day." Therefore the actual best before date is January 16, 2015.  To further support the January 2015 date, this product was manufactured in July of 2013 and has an 18 month best before date.

Conclusion and Next Steps:

Based upon the Covance test results, the formulation for MUSCLE MLK® powder, and the analysis above, it is clear that test results from CBC are not only erroneous, but significantly so. There are several possible reasons why the test results CBC obtained are incorrect:

(a)  Lab mix-up: Because the amino acid profile is so much different than not only the product formulation, but also what would be expected for any milk protein-based product, it may be that the lab accidentally mismatched samples with lab results.
(b)  Other lab error: The lab may have performed a step of the assay incorrectly or had another error that lead to this result. Without the actual COA from the lab CBC utilized, we do not have enough information to determine whether the lab may have made some errors in either its procedure or the assumptions it made. But the lab results are so far off from what would be expected for any milk protein-based product that CytoSport believes this is the most likely cause.
(c)  Counterfeit product: The product tested may have been a counterfeit product. We had previously requested photos of the product from CBC in order to be able to determine this, but have not received photos to date.

Regardless of the reason for the errors in the CBC test results, we believe it is in both parties’ best interest to conduct further testing to determine what may have gone wrong in the analysis.  There are several ways we can accomplish this. First, we could agree upon another well-respected nutrient analysis laboratory and send that laboratory sub-samples from both the product retain held by Covance, as well the product tested by CBC’s laboratory. The third party laboratory’s testing should either confirm the discrepancy between the two sets of test results or reveal an error by one of the two labs at issue. Second, we could agree to exchange sub-samples of the product retain held by Covance and the product purchased by CBC, so that Covance tests the product purchased by CBC and CBC’s laboratory tests CytoSport’s product retain. Again, this will reveal whether the issue is one of lab error. Third, the parties could send additional product – whether product retains from CytoSport’s warehouse, product being held at other warehouses prior to be shipped to retailers, or product directly off retailer shelves – to both laboratories for testing.

In the analysis and test results we previously sent along, Covance did use HPLC to test for both free form and total amino acids (see the "Method References" section at the bottom of page 2).  That test found no free form amino acids, and 34.6g of total amino acids, meaning all of that 34.6g of amino acids was from protein.  The standard Dumas nitrogen test, adjusting for Non-Protein Nitrogen Sources, came up with a consistent result for protein.  Again, all testing supports our product's protein claims and we are confident in those results.  Just as important, the test results CBC provided appear to be from a product that doesn't include any form of milk proteins, since the results found no valine or tryptophan.


STATEMENT FROM GNC
(GNC Lean Shake 25, GNC Mass IV Pro Performance, Vitamin C)

GNC stands behind the quality of its products and believes that both products meet label claim.  We note that sample preparation and using the appropriate test method are critical when testing products to prevent an inaccurate test result.  We would be happy to further discuss this issue with you if you have any questions concerning our response.
1.  With regard to the Lean Shake product, the product does contain 25 grams of whey protein, the full amount of protein stated on the label.  No free amino acids were added to the product and we do not use free amino acids as protein content for label claim purposes.   Protein concentrates and isolates contain smaller peptides that can hydrolyze easily in sample preparation, making the product appear to contain free amino acids.  Protein concentrates and isolates contain a low level of free amino acids due to the manufacturing process.  This is likely the reason your test showed some free amino acids.
Also, while the lab you used may be accredited,  the method of analysis employed does not appear to be validated.  The results of  your laboratory analysis appear to indicate that the product contains ZERO naturally occurring quantities of the following common amino acids:  Aspartate, Glutamate, Serine, Arginine, Cysteine,  Leucine, Asparagine, Glutamine, and Tryptophan.  To the contrary however, it is well established that whey protein concentrate (80%) contains the following percentages of these amino acids (by weight): 8.4% Aspartic acid, 13.3% Glutamic acid, 4.6% Serine, 2.3% Arginine,   1.7% Cysteine, 8.8% Leucine,  1.3% Tryptophan.  This red flag should call into question the lab's findings. [all of those were found by only the free, not the bound]
2.  With regard to the Vitamin C product, we tested retained samples of the lot in question using a direct titration with iodine solution (referencing the official USP Ascorbic Acid titration method).   The testing results demonstrate that the product meets label claim. 
The test method used by the lab chosen by CBC Marketplace is a fluorometric method developed in the late 1960's which involves many steps that increase the chances of an inaccurate test result.

Protein supplements are tested for protein content by AOAC procedures that are published and reviewed frequently at the AOAC conventions.  In the specific case of protein assay, there are two procedures that we use called the Dumas method (AOAC 968.06) and the Kjeldahl method (AOAC 991.20 for milk products).  Both of these methods measure the amount of nitrogen present in the product, and that found percentage of nitrogen is converted mathematically into the percent protein.  These tests have been used for a very long time in the meat, grain, and other food industries.


November 10, 2015

GNC informed Marketplace that an independent lab performed an analysis, by HPLC, and found no free amino acids in the product (all amino acids were from protein). 


November 13, 2015

GNC provided CBC with irrefutable evidence, including independent testing, that the results of CBC’s testing are scientifically inaccurate, and that any claims made on the basis of these results are false and misleading.   We are deeply disappointed that CBC has chosen to use such erroneous results.

GNC stands by its products, all of which are submitted to rigorous and generally accepted testing before they reach our customers.  When industry-wide standards are used to authenticate the ingredients in our products, the results demonstrate they are properly labeled.

 

STATEMENT FROM JAMIESON
(Red Super Krill, Omega 3 Complete, Vitamin C)

Sept 30, 2015

Thank you for giving us the opportunity to share details on our rigid testing standards. We take our testing and quality processes very seriously. While reviewing your questions we have consulted several expert sources. Three leading industry organizations have all confirmed that the method for testing anisidine levels as outlined in the GOED Voluntary Monograph is not a valid testing methodology for krill oil:

  • GOED ( Global Organization for EPA and DHA Omega-3s) – GOED has stated the testing methodology for anisidine value (AOCS Cd 18-90) in the GOED Voluntary Monograph is not a suitable testing method for krill oil. As the monograph states, the testing methodology is “applicable to omega-3s obtained from fish, plant, or microbial sources”. As krill oil is sourced from krill, which is a crustacean, this testing methodology does not apply. Tests conducted on krill oil under the GOED methodology would yield inaccurate and artificially high results of anisidine, as the test results that Marketplace attained for Jamieson OmegaRED Super Krill 1,000 mg have shown.
  • IKOS (International Krill Oil Standards) - IKOS does not use the GOED Voluntary Monograph because it is not suitable for testing krill oil, as there are ingredients naturally occurring in krill oil that are not present in oils of fish, plant or microbial sources, and therefore are not accounted for in the GOED methodology.
  • USP (United States Pharmacopeia) - USP is a scientific organization that “sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide”. USP has stated that they do not conduct the standard fish oil anisidine test on krill oil because an accurate result cannot be obtained using the standard method utilized for fats and oils. USP determines krill oil freshness by a standard test that measures the oxidative status of the oil, i.e. its peroxide value.


According to USP guidelines, the peroxide value of krill oil should not exceed 5 mEq peroxide/kg. Jamieson follows the guidelines of USP, and the peroxide test is just one of approximately 30 tests that every lot of our krill oil must undergo and pass before being released for sale. Jamieson test results show that at time of manufacture, the specific lot number tested by CBC Marketplace ((L)3487952) was found to have a peroxide value of 0 out of 5, meaning it was as fresh as possible. Approximately 20 months later, on Sept 29, 2015, an independent lab has verified that the peroxide value is now 0.5 mEq peroxide/kg which remains well within USP guidelines for freshness.

If you have any additional questions on krill oil testing methodologies, we encourage you to reach out to any of these organizations that can provide you with more detail.

We have reviewed the EPA/DHA test result you sent us with our Science and Technical Affairs team. At Jamieson, we retain samples of all finished goods from every lot produced. We have re-tested a retained sample of lot number (L)3487952 tested by Marketplace. Our test results are consistent with label claims and remain within Health Canada approved guidelines as expected. We have attached our test results for your review. As you will see there is a significant difference in the test results. Would you please kindly confirm that Marketplace’s lab results are based on one softgel per day (the daily serving size for Jamieson OmegaRED Super Krill 1,000 mg) vs a 2 per day serving size which is common with other brands?

In summary, we are confident our Jamieson OmegaRED Super Krill 1,000 mg product is and will remain fresh until the expiration date noted on the label, and that the EPA and DHA levels are appropriate as claimed within Health Canada approved guidelines.

VITAMIN C
November 10, 2015

We believe very strongly in the importance of providing comprehensive information to consumers. All of the product information on our website is scientifically accurate.


November 11, 2015
Jamieson retested our retained sample for this lot number and validated it is still at 100% of label claim with 1000 mg of vitamin C.

As with the tests we discussed previously, the testing methodology Marketplace used does not adhere to current industry standards resulting in CBC’s inaccurate test results. The vitamin C testing method Marketplace used is a 47 year old methodology last updated in 1968 (AOAC) that is outdated, inaccurate and inconsistent with Health Canada regulatory requirements. Jamieson uses the far more accurate United States Pharmacopeia (USP) testing method published in 2008, which is the current industry standard and also required by regulators including Health Canada.

Our stability reports indicate the Jamieson vitamin C is stable for at least 36 months from the date of production and for this lot, will remain stable and fresh well past its August 2017 expiration date.

 

STATEMENT FROM NATURAL FACTORS
(Natural Factors Maximum Triple Strength Omega-3)

Thank-you for sharing the test results and observations from the contract laboratory you utilized.  I can assure you that the fish oils we use are of the highest quality and are sourced from the leading providers of these materials, fully compliant with GOED and CRN expectations, among others.  We have decades of experience in the manufacture and testing of these materials and products.  We are confident in the superior quality of the products and the superior quality of the oils.  We began our own investigation immediately upon receiving your communication.

Our test results for peroxide value for this lot at the time of release were 3 meq/kg and 4 meq/kg.  When we received your communication, we repeated the peroxide value test on a retained sample from this lot and obtained a value of 4 meq/kg once again.  It is not uncommon for some variability in results from lab to lab.  All results are, in fact within accepted limits.

As the expiration date on this product is February 2018, it has been pointed out that this product will fail oxidation levels prior to the expiration date. All fish oil supplements are expected to pass oxidation testing through to their expiration dates.

Our stability data for this as well as similar fish oil products actually indicates that little to no increase in oxidation levels occurs over the course of shelf life.  The capsule shell has very limited permeability to atmospheric oxygen, which makes this a very good dosage form for such oils.  The bottle and cap configuration further bolsters the stability of the products by minimizing exposure to the external environment.  There is no reason to extrapolate an assumption that the product will fail prior to the expiration date.

In addition, this product had more total Omega-3 content than what was claimed on the label by 35.5%, as well as more EPA and DHA than what was claimed.

These results are higher than, but not altogether inconsistent with, our test results.  Our initial test values at time of release were 104 – 113% of labeled amounts.  Subsequent to your communication, we again conducted this analysis, and the retest value for retained sample was 116% of label claim, entirely consistent with our initial findings.

The test method utilized for these analyses has been validated in accordance with ICH guidelines (as well as USP, FDA and HPFBI expectations) and has been demonstrated suitable for our materials and products as stipulated by these authorities.  The analytical method and associated Method Validation protocol and report is routinely reviewed by a number of the previously noted regulatory agencies during audit inspections.

All results are well within our specification limits established for such products in accord with Health Canada/NNHPD guidelines.  It would be unusual to find results that exactly match the label claims.  All products are formulated to contain the labeled amounts, at a minimum, at the time of product manufacture.  These observed results fall within established and agreed to ranges and within allowable levels.

To give you a bit more detail, Marketplace had all our products tested in an independent, FDA-registered, ISO 17025-certified laboratory.

All tests are performed in-house by qualified staff.  Furthermore, test results may be periodically confirmed via product testing performed by independent, third-party laboratories as well, all of which are accredited by a variety of recognized institutions and subject to audits by such regulatory agencies as HPFBI, FDA, and TGA, as well as USP and NSF.  It is unusual for third-party laboratories to validate methods or methodology that are demonstrated to be suitable to specific products, unless they work in collaboration with the supplier of the materials or products.

We are hoping to understand more about this product result from you, and look forward to hearing back from you as soon as possible.

As I stated initially, the fish oils we use are of the highest quality and sourced from the leading providers of these materials, fully compliant with GOED and CRN expectations, among others.  We have extensive experience in the manufacture and testing of these products.  Our manufacturing and laboratory facilities comply with current Good Manufacturing Practices, and all activities are subject to audit by NNHPD, TGA, FDA, USP and government accredited third-party contractors as well.  We are confident in the superior quality of the oils and the superior quality of the products.

Again, we thank you for allowing us to provide this information and address your concerns.

 

STATEMENT FROM NATURE’S BOUNTY (NBTY)
(Nature’s Bounty Omega 3 Fish Oil, Body Fortress, Ester-C)

October 1, 2015

We reviewed the lot in question and found all test parameters met our specifications at the time of manufacture for the fish oil and soft gels manufactured for this lot of production.  Stability studies for fish oil products show that similar formulations support the shelf life for this product.

Lab tests will vary on methodology and quality of testing regime. We cannot verify how the producers tested the product; however, we can demonstrate that our results were from validated methods under controlled conditions. 

Products can be affected by environmental conditions during distribution and stocking which can lead to further variance in test results.

NBTY confirms that our test results are valid for the majority of distribution conditions and we stand by the quality of our products across their stated shelf-life.

As a health and wellness company, we are proud of our 40 year history of delivering high quality and safe Vitamin, Mineral, Herbal and Supplement (VMHS) products.   Our products go through rigorous testing protocols that fully adhere to Good Manufacturing Practices (GMPs) to ensure their integrity.   Our raw materials are authenticated upon receipt and finished products are tested to ensure potency as part of our routine testing procedures for every lot of product.

The table below is the results attained just prior to packaging.

Review of the release data for Enteric coated fish oil 1000 mg (coated soft gel)Bulk 3832 lot 896341  showed the following results.  The method used for these tests are USP 401 for the oxidation parameters test which are equivalent to the method used by the external laboratory.

Assay

Spec

Results

QA status

Total omega

300 mg

374 (124.7%)

Pass

EPA

report results

167 mg

N/A

DHA

report results

137 mg

N/A

Total Omega

NLT 300

374 mg

Pass

Peroxide value

≤ 5.0 meq/kg

1.4 meq/kg

Pass

Acid value

≤3 mg KOH/g

0.2 mg

Pass

Anisidine value

≤ 20.0

4.6

Pass

Totox

≤ 26

7.4

Pass

 

November 11, 2015

Thank you for your update on these products.  I am glad to see that you are reaching out to the experts to understand the Vitamin C findings.  As you noted below, “Experts have advised us that Vitamin C does degrade over time with exposure to oxygen and high humidity because its chemical structure is highly unstable, and this could affect the measured Vitamin C content.”

Regarding your questions about oxidation, just this week, the Global Organization for EPA and DHA Omega-35 (GOED) released a white paper on fish oil and oxidation that you should have received.  If you have not, I would be happy to pass it on to you.  Here are some key points, which completely negate your premise.

  • Oxidation is a normal process that happens with all fats and oils that contain polyunsaturated fatty acids.  While some oxidation always occurs, it should not rise to the level of any medical or safety issue as long as it’s tested properly prior to release.
  • Oxidation is simply what happens to the unsaturated fatty acids found in fats and oils when  they are exposed to oxygen
  • Human clinical trials conducted with oxidized EPA and DHA oils have found no negative effects and many of these trials with commercially available EPA and DHA oils have found beneficial impacts on the oxidative status of the tissues in our body

As demonstrated by the stellar results you found when you tested our Vitamin C and Whey protein, I want to reiterate the following points around our fish oils.

  • We use only the highest-quality ingredients to make our products and we take industry-leading measures to ensure the safety of both these ingredients and the resulting finished products.
  • The raw materials / ingredients used in all our products are sourced from large scale, high quality manufacturers.  Each manufacturer is subjected to a rigorous evaluation, auditing, testing and approval process before they become a supplier.
  • The U.S. facilities where our softgels are manufactured have been approved by Health Canada based on evidence of compliance with Good Manufacturing Practices (GMPs).  In addition, these facilities are regularly audited by our internal Quality department as well as 3rd party organizations to ensure on-going compliance.
  • As with all our products, we abide by specific standards in manufacturing our fish oil and soft gel products.
  • Every batch of product we receive is assessed from point of receipt and throughout the manufacturing and/or packaging process to ensure it is within specification and the manufacturing process was in accordance to the GMPs.  Product testing is conducted using validated testing methods based on well-defined scientific and industry standards.

When your correspondent arrived at our facility unannounced, we tried to educate her, but it appears from her repetitive line of questioning that she was not interested in understanding the science and providing your viewers with the facts.  She kept insisting the product was rancid and causing harm.  Rancidity is a general term used to describe undesirable odors and flavors that develop as oils age and are exposed to oxygen and temperature. Highly unsaturated fatty acids make fish oil products particularly susceptible to oxidative deterioration. This natural aging process would not impact of the safety or efficacy, EPA or DHA content, of the fish oil product. 

While there is no health issue associated with this product, if a customer is not satisfied with any of our products they can call our hotline and request a replacement.


PFIZER RESPONSE AND STATEMENT
(Emergen-C)

Thank you for contacting Pfizer Canada with your questions related to EMERGEN-C.

As a manufacturer of prescription medicines and natural health products, Pfizer is responsible for ensuring that these products are manufactured, packaged, tested and distributed with respect to current Good Manufacturing Practices (GMP) in order to maintain the highest level of quality and integrity.

To meet this commitment, Pfizer developed manufacturing processes and analytical methods specifically validated for the production and analysis of EMERGEN-C. Each lot is analysed prior to release to ensure that the manufacturing was performed according to the approved methodology.

Each step of the manufacturing and packaging process has been designed to ensure the quality and the integrity of the product from its manufacture to its expiration.  Regular in-process testing is performed throughout the manufacturing process to control and monitor the quality and the integrity of each lot produced. Our rigorous stability program involves placing EMERGEN-C products in environmental chambers and analyzing the product at regular intervals to ensure that label claims and unique characteristics are maintained throughout its shelf life.

When it comes to analytical testing of any products, all test methods are required to be validated according to current recognized international standards established by the FDA and Health Canada as well as in accordance with The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines.   It is important to ensure that each method is accurate, precise and specific to the ingredient being analyzed, with consideration to prevent any alteration of the product during the analysis. For example, the use of low-actinic glassware is required for water-soluble vitamins which are sensitive to light.

Without a method validated specifically for EMERGEN-C, any testing cannot be considered valid as the results obtained may not represent the true value of the ingredient being analysed.  As such, we caution CBC Marketplace from making product quality assumptions based on third-party analyses using general methods.

STATEMENT FROM PFIZER CANADA INC.

With respect to your specific query, our manufacturing documentation and analytical results for the lot of EMERGEN-C Super Orange (Lot number 1410C006) were reviewed and we can confirm that this batch was manufactured according to the validated manufacturing process and our analytical tests results confirm that all ingredients are meeting the label claims.

With respect to your query regarding the “helps to maintain immune function” claim, we confirm that this purpose of use is approved and permitted based on the presence of zinc in the formulation as per the Health Canada Multi-Vitamin Mineral Supplement Monograph and the Zinc Monograph.  Pfizer meets the standards of evidence for the product to support this claim.


STATEMENT FROM SWISS NATURALS
(Vitamin C)

Swiss Natural has been proudly supplementing Canadians for over 50 years and is committed to product safety and efficacy.  Our testing specifications are reviewed and approved by Health Canada as part of our product license.  Using the same Swiss Natural Vitamin C tested by Marketplace – Material #129000, batch (SW 1521601) our USP testing confirms that Swiss Natural Vitamin C meet their product label claims.
 

WEBBER NATURALS TREEHOUSE GUMMIES
(Omega 3 and Vitamin C)

We appreciate the opportunity to respond to your concerns.  Please be assured that we are confident that this product meets peroxide levels and Omega 3 label claims.  Science based testing and exceeding GMP quality requirements is a priority, all raw materials and bulk products are thoroughly tested prior to release to the consumer.   Please find below a summary of our investigation:

GOED was contacted by our company; the GOED voluntary monograph doesn’t apply to gummies as that falls under ‘special delivery system’. There is no monograph for special delivery systems (or methods applicable to gummies) nor any changes pending to the existing monograph. The monograph was created for fish oil or fish oil encapsulated.  (see highlights attached)
Flavors may interfere with the peroxide value results
However, to ensure we have a baseline we have modified the extraction of the gummy and do perform peroxide test according to USP<401> which is very similar to the AOCS Official Method Cd 8-53 method.  Our test result is 0 meq/kg.  Based on stability information, result is 2 meq/kg at 24 months, well within the allowable range. The fruity taste is also maintained and palatable thru out the shelf life.
We have reviewed the Omega 3 results for this lot and EPA and DHA test results are within the 80 – 165% NNHPD allowable limit.  Specifically, Omega 3 22.2mg/99%, EPA 7.8mg/104% and DHA 14.4mg/96%Method used is similar to GOED. We are questioning if there may be an error in calculating using other Omega peaks for this high result?  
GMP’s are followed in the manufacturing facility this ensures master formula instructions are followed with documented checks and yield checks for raw materials and bulk product.  The overage of 596% is also not economically practical and would also result in an unpalatable product with a strong fishy odor and taste.

In summary, we appreciate CBC Marketplace and your efforts in researching products to ensure consumer product effectiveness. We are happy to work with CBC on understanding the appropriate methods to ensure accurate results are reported and ensuring the lab has the accreditation and experience for the product type in question. We are confident in the quality of our product and do our utmost to ensure that all product that we market is tested to meet or exceed government regulations.

November 4, 2015

Thank you for your recent communication.  To summarize our previous communication, we have thoroughly investigated your concerns, explained our testing accuracy and spoken to the fact that we consistently produce product according to GMP’s that meet the parameters set forth by the NNHPD under Health Canada.  Our initial testing of the Omega 3 Gummy was within specification and our retest results after receiving your email, 3 months after packaging, also met label claims.   The on-going stability program shows this product to meet potency and all other test parameters as per the assigned shelf life.

We thank you for sharing what you believe to be a concern and are pleased we were able to alleviate your concerns.