Be Natural Organics FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://www.benaturalorganics.com/ in April 2017 and has determined that you take orders there for the products Calendula Cream Soap, Chamomile Balancing Mist, CoQ10 Eye Protection Cream, Gentle Face Lotion, Amaretto Body Scrub, Pomme D’Or Anti-Aging Crème, Daily Botanical Enzyme Peel, Squalane Serum, and Sea Kelp Moisturizer. The claims on your website establish that the products are drugs under section 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § § 321(g)(1)(B) and/or 321(g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or fun

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

• “…Calendula is known to be antiseptic, anti-inflammatory, and immune stimulating. These properties are suitable for treating various types of dermatitis such as eczema.”

Potential Health Risks

• “Stimulates new healthy cell production and growth”• “Squalane [(an ingredient in your product)] -… it is antibacterial and has been scientifically proven to clear up difficult skin problems (eczema, dermatitis, rashes, etc.).”

Regulatory Context

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. If you do not believe your products are in violation of the Act, include your reasoning and any supporting information for our consideration. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.

Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.