A Response to Consumer Reports

11/28/2019 |
Better World, Conscious Healthy Living, Uncategorized

Since 1936, Consumer Reports (CR) has acted as a product safety watchdog on behalf of the public, assessing, then publishing information on product safety and performance. CR played roles in legislative reforms such as seat belt laws and the dangers of tobacco consumption.

While we are grateful for the necessary discourse that holds products accountable, this discourse is weakened, and even harmfully misleading, when it doesn’t observe industry-wide testing standards developed by government and industry bodies. It leads to skewed results and misinformation in an age where our wellness itself is tied to truth.

In recent years, CR has targeted the natural and nutritional supplement industry in search of fraudulent or misrepresented products from a stance that natural products are guilty until proven innocent. While there have indeed been poor quality products in the marketplace, legitimate manufacturers like ORGANIC INDIA have made great efforts to provide the highest quality, most efficacious products, complying with regulatory testing and GMP, or good manufacturing practices. In the case of CR’s recent testing of ORGANIC INDIA Turmeric supplement, Mollie Kober, an independent U.S. Food and Drug regulatory expert said, “The Consumer Report testing attempts to confuse consumers regarding the safety of this product.”

ORGANIC INDIA Turmeric falls under Consumer Reports Scrutiny

Recently, CR published an article in its December 2019 issue on several echinacea and turmeric products, including ORGANIC INDIA’s turmeric supplement. CR stated that ORGANIC INDIA Turmeric exceeded acceptable levels of aerobic bacteria plate counts — but upon review of the details of CR testing methods, questions arise that were not addressed in the CR article. The CR article stated that, “While none of the products we tested contained E. coli or salmonella, some significantly exceeded the USP standards for aerobic bacteria. Higher aerobic bacteria levels don’t necessarily make a supplement unsafe to take, but they can indicate that products were manufactured or processed in unsanitary conditions.” 

Bacteria: A Trigger Word

The above statement is over-simplified to the point of being misleading to consumers. For many, the word evokes images of health-threatening pathogens. But bacteria are everywhere — on every surface, and in the air. In fact, many bacteria are healthy, such as probiotics. The CR report does not explain what aerobic bacteria are — air-loving microorganisms that require oxygen to reproduce. Aerobic bacteria can grow only in the presence of oxygen, and over time. Significantly, the herbs in ORGANIC INDIA herbal organic supplements contain no oxygen or moisture — encapsulation eliminates those factors necessary to bacterial growth.

Different test protocols, different results

There is a multitude of safety testing protocols from different organizations; The United States Pharmacopeial Convention (USP), FDABAM, The American Herbal Products Association, or the NSF International to name a few. According to the CR article, “‘Supplement companies can choose among many standards—or no standard,’ says Tunde Akinleye, a chemist in Consumer Reports’ food safety division who led our testing.” 

This is a notable mis-statement — the gold standard for product safety testing is the United States Food and Drug Administration Bacteriological Analytical Manual (FDABAM).  Because the FDA has the power to remove products from the marketplace, it is considered “best practice” to comply with FDA testing protocols — hardly an arbitrary choice. Any batch of ORGANIC INDIA herbs that does not fall within FDA safety standards for aerobic bacteria is destroyed. 

According to ORGANIC INDIA’s testing lab, “The testing methods used by CR’s laboratory are not the industry standard USP 2021, 2022 methods, ‘Microbial Tests for Nutritional and Dietary Supplements.’ Instead, CR’s lab utilized USP methods 61 and 62 for ‘Microbial Examination of Non-Sterile Products.’” 

FDA regulatory consultant Kober said, “The safety of a dry powder product is determined by the presence or absence of harmful bacteria such as pathogens. The ORGANIC INDIA turmeric product is shown to not contain any pathogenic organisms and is therefore safe for consumers.”

This different testing protocol exposed ORGANIC INDIA Turmeric to air for three to five days, in contrast to the industry standard FDABAM USP 2021 2022 method protocol wherein aerobic bacteria plate counts are made after 48 hours of exposure — the widely-used industry standard. CR’s non-standard USP 61 and 62 increase the chances of higher levels of aerobic bacterial growth due to the test material’s longer exposure to air. 

After reviewing CR’s test findings, FDA regulatory consultant Kober said, “The safety of a dry powder product in terms of microbiological loading is determined by the presence or absence of harmful bacteria such as pathogens. The ORGANIC INDIA turmeric product is shown to not contain any pathogenic organisms and is therefore safe for consumers.”

Kober went on to state that the presence of bacteria in an aerobic plate count is not an indication of product safety — indeed, the only consumer products with zero aerobic bacteria plate counts are highly refined, preservative-laden foods such as processed cheese products.

World Health Organization Test Protocols

Because ORGANIC INDIA products are internationally distributed, the company’s Lucknow, India test labs use World Health Organization (WHO) testing protocols and limits alongside USDBAM protocols. The ORGANIC INDIA lab stated: “We have investigated this issue and our findings are as follows:

“We use WHO (World Health Organization) specifications for Aerobic bacteria and CR has used USP specifications meaning that USP is using more stringent specifications.

“In the current process, we steam treat our herbs in a way that brings the microbial population down to within WHO specification, avoiding harsher heat treatment to allow herbs to sustain medicinal properties. 

“The study conducted by CR uses USP (United States Pharmacopoeia) method of enumerating Aerobic bacteria, whereas ORGANIC INDIA uses USFDA BAM (Bacteriological Analytical Manual) methods — we have been using USFDA BAM methods since inception.

Aerobic bacterial is not harmful. It is present everywhere. What concerns is the presence of pathogenic bacteria, which is ensured to be absent in all ORGANIC INDIA products.

 “Moreover, aerobic bacterial is not harmful. It is present everywhere. What concerns is the presence of pathogenic bacteria, which is ensured to be absent in all our products.

“If we adopt USP standards we need to increase the heat treatment of our herb which is detrimental to the quality of product as heat takes away essential oil and other medicinal properties of the herb. Hence it is not advisable to follow USP standards. We will stick to WHO and FDA specifications.”

Questions regarding test material handling

ORGANIC INDIA has concerns regarding CR’s product handling — CR stated that it removed Turmeric capsules from their original packaging to be distributed to testing labs, but did not specify how those capsules were handled, and under what conditions. Were the capsules transferred under sterile conditions? How were they handled? When ORGANIC INDIA asked this question, CR declined to describe their sample handling protocols. 

New Hope Network responds to CR article

According to an article published in the New Hope Network website news section, “The Council for Responsible Nutrition [CRN] called the article ‘a thinly veiled and poorly researched assault on the dietary supplement industry with ill-informed opinion posing as fact.’ CRN also criticized Consumer Reports for ignoring existing stringent standards in favor of ‘its own arbitrary standards that are neither grounded in science nor relevant to consumer safety.’”

The article goes on to state, “The ‘concerns,’ identified are related to factors on which Consumer Reports assigned analytical targets that ignore federal labelling regulations and quality standards developed by AHPA and other authoritative organizations.

As a company committed to the highest possible product integrity, ORGANIC INDIA is scrupulous in observing testing and manufacturing best practices as defined by the Food and Drug Administration (FDA) and the WHO, and consistently meets those standards. We sincerely hope that CR takes the same care in product testing that ORGANIC INDIA does in compliance with FDA regulations and Good Manufacturing Practices (GMP). ORGANIC INDIA will continue provide wellness solutions in service to a community dedicated to heathy, conscious living.