FDA Warning Letters

FDA Warns Boutique Soap Maker Be Natural Organics

In recent months we’ve seen the U.S. Food and Drug Administration, or FDA, scrutinize a number of small soap making companies; this time it is Joanne O’Donnell’s Be Natural Organics finding itself in the agency’s crosshairs.

Typically, soaps–assuming that they are true soaps and not detergent bars–are safe from FDA scrutiny, provided that they are not marketed with medical or health claims. But when agency investigators visited O’Donnell’s website, BeNaturalOrganics.com, they found marketing spiel that they say went over the line.

Organic Calendula Cream Soap

O’Donnell’s Organic Calendula Cream Soap was called out for claims that the product could treat skin conditions like eczema due to its “antiseptic, anti-inflammatory, and immune stimulating” properties.

 Organic Calendula Cream Soap with FDA-warned claims.

Screengrab of archived page for Be Natural Organics’ Organic Calendula Cream Soap, showing now-removed claims for eczema, inflammation and immune stimulation.

Chamomile Balancing Mist

Her Chamomile Balancing Mist got the FDA’s attention for claims that ingredients used to make it could “calm irritated skin”, “reduce redness” and were anti-allergenic, anti-bacterial and anti-inflammatory.

CoQ10 Eye Protection Cream

With her CoQ10 Eye Protection Cream product, O’Donnell hinted that the cream might optimize cellular metabolism and increase collagen production.

Gentle Face Lotion

A lotion made with rose water, witch hazel and acai berry extract claimed to reduce inflammation, promote wound healing and even light hyperpigmentation.

Amaretto Body Scrub

Be Natural Organic’s Amaretto Body Scrub promised to increase circulation, improve lymph flow and bring blood to the skin.

Pomme D’Or Anti-Aging Crème

The company’s Pomme D’Or Anti-Aging Crème promised to stimulate cell production; its squalene ingredient was supposed to help “clear up difficult skin conditions”, including  dermatitis.

Squalane Serum

Another product with squalene in it is O’Donnell’s Squalene Serum, which she suggested could “prevent brown spots”. With its “antibacterial properties” it could also “clear up” acne.

Daily Botanical Enzyme Peel

Purported “strong antibacterial” ingredients also appear in a facial peel. The Daily Botanical Enzyme Peel products is a do-everything cosmetic that could decrease age spots, stimulate cell growth, increase both collagen and elastin and prevent acne.

Sea Kelp Moisturizer

A moisturizer made with seaweed touted its “analgesic, anti-inflammatory and healing” properties, while acting as a natural sunscreen.

Naturally, the FDA says that none of the agency-cited products has ever been officially recognized as effective for any of those issues, making them new (and illegal) drug products. It gave Be Natural Organics the normal 15 working days to remove the alleged violating claims and present a plan to prevent future marketing violations in the future.

The FDA warning letter to Joanne O’Donnell and Be Natural Organics was dated July 19, 2017. As of my visit to the company’s website this morning it appeared that the cited claims had been removed.


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