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05-Jul-2022 - Last updated on 05-Jul-2022 at 16:57 GMT

Related tags: Adulteration, understrength products, elderberry, Fraud, Food fraud

Supplement marketer Dakota Nutrition’s claims for the elderberry content of its products were challenged by Nature’s Way in a National Advertising Division proceeding.  NAD ruled on claims relating to three products: Extra Strength Elderberry 3-in-1 Immune Booster Capsules, Extra Strength Elderberry Gummies, and Immune Defense 7-in-1 Immune Booster Capsules. 

NAD recommended that the advertiser discontinue the challenged claims, which included:

The NAD also ruled that the word “elderberry” should be dropped from the Elderberry Capsules and Elderberry Gummies product names.  NAD said that this is an express claim that the products contain meaningful amounts of the named ingredient. However, the advertiser’s evidence did not provide a reasonable basis for claims related to the presence of elderberry in these products.

For example, the  Dakota Nutrition Elderberry Gummies contain 150 mg of ‘elderberry fruit extract’ in a serving of two gummies according to the Supplement Facts panel.  In the Elderberry Capsules, the manufacturer claims 1000 mg of ‘Elderberry Immune Complex,’ which lists ‘elderberry extract’ as the first ingredient of a three-component blend.  The 7-1 Immune Support capsules claim 350 mg of a ‘Proprietary Immune Defense Blend’ which lists ‘Elderberry Fruit Extract’ as the first ingredient.

As to the verification of the contents of these supplements, the company has this to say on its website:

“Before that bottle arrives to your location, it goes through stringent third party testing that includes testing the raw materials and ensuring purity and potency. We also test for the exact concentration of ingredients to ensure absolute safety and effectiveness.”​

Elderberry was one of the immune support ingredients that saw a huge surge in demand at the beginning of the pandemic. As with many botanicals, the supply is somewhat inflexible and can’t respond quickly to rapid demand spikes.

However, sales of products claiming elderberry content nevertheless went through roof, increasing to as much as $320 million in 2020​​, according to the annual American Botanical Council Herb Market report.  At the same time, Nature’s Way had struggled to keep its own elderberry products in stock using validated raw material, while bottles from other manufacturers flew off the shelves.

In cooperation with the ABC, in late 2020 Nature’s Way publicized the results of tests​​ it had done on 25 commercially available elderberry extracts as well as eight finished dietary supplements. Of the 25 bulk materials, 14 failed the identity test (very low amounts of cyanidin-3-O-sambubioside compared to other anthocyanins), and five were found to contain no elderberry extract at all. Black rice extract was found as an adulterant in at least two cases. Among the eight finished elderberry dietary supplements, two products were devoid of elderberry extract. One contained mainly a substance similar to oat bran, while the other was made of Vitamin C and excipients.

Dakota Nutrition said that it “respectfully disagrees with NAD’s rejection of raw material testing”​ of its botanical ingredients, which it believes “should be sufficient to satisfy NAD standards.” ​However, in its advertiser statement the company said it “supports the self-regulatory process and will abide by NAD recommendations in future advertising.”​

Despite that agreement, the challenged products remain for sale on the company’s website.  Dakota Nutrition did not respond to a request for further information before publication time as to when it will rename and/or reformulate the products.

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Related topics: Markets, Regulation, Supply Chain Management, Regulations, Legislation & Enforcement, Adulteration, Antioxidants/carotenoids, Polyphenols, Botanicals, Immune support

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