Kojie San U.S. - Kojie San soap claims

Monday, July 03, 2017

There's a brand spanking new company on Facebook called Kojie San U.S. that is selling a soap on Amazon, and as of this blog post only on Amazon, that is marketed as a cure for Keratosis Pilaris and that it will help lighten your skin. InStyle did an article on Kojic Acid and briefly talks about how Kojic Acid is made.

Let me preface this by saying I'm not out to destroy this company, or say the products are bad, or anything like that but the fact is that in the United States there are certain things a company can and cannot market their products as and the claims made on Kojie San's Facebook is one of those things that they can't do. There is no way to contact Kojie San USA other than directly on their Facebook wall, which I did and was promptly blocked for pointing out that they can't claim the soap cures Keratosis Pilaris as this would cause the US FDA to issue them a warning. This was the case for Soapwalla who was issued a warning letter from the FDA earlier this year and who has since fixed their descriptions and claims.

What I do know about this company is based from their Facebook and Amazon pages.

From Amazon:
***Our Kojie San soaps are original product from the Philippines and sourced directly from an accredited manufacturer's distributor. They were shipped from Philippines and sent to our warehouse in Los Angeles. The Kojic Acid you've always trusted, the one prescribed by your dermatologist is now available in Kojie san Skin Lightening Soap. Kojie san contains high grade cosmetic all-natural Kojic Acid that helps prevent melanin production making skin lighter and clearer. Kojie san Skin Lightening Soap is effective in diminishing dark spots, freckles and acne, stretch marks, uneven skin tone and other skin tone disorders. Kojic Acid was discovered in Japan, it is a byproduct of Koji or Malted Rice used in the production of rice wine. In cosmetics, kojic acid is popularly known for its remarkable whitening effect and antioxidant properties. HOW TO USE: For daily use on face and body. For optimum result, use Kojie san Lightening Body Lotion w/ SPF25 after bathing.

From my understanding, Kojie San is a popular soap in the Philippines and that the Philippines Facebook page has over 35,000 likes. Whether or not you can get it from a dermatologist in the Philippines is something I can't verify since I'm not from there but in the US I've never heard of this soap prescribed by a dermatologist. And that goes back to the whole drug claims because for a doctor in the US to PRESCRIBE something in the US it MUST be approved by the US FDA. So that's a second claim by the company that's misleading and can get them into trouble with the US FDA.

As mentioned before, Soapwalla got into trouble with the FDA for something similar - making claims about their soaps "curing" different things. This is also what Sigma can get into trouble for as well with their brush soap claim.

From the FDA to Soapwalla, and what the FDA can issue a warning to Koji San over:

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 articles intended to affect the structure or function of the human body. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

[snip information on what items were issued warnings over]

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), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

This letter is not an all-inclusive statement of violations associated with your products or their labeling, and we have not attempted to list here all of the products that are promoted on your website for intended uses that cause them to be drugs. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.

We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to do so may result in enforcement action without further notice. The Act authorizes injunctions against manufacturers and distributors of illegal products and seizure of such products.

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.

Whether or not you buy this product is up to you, however, just be aware that the claims made by Kojie San U.S. and on Amazon.com via Cart2 USA LLC and Triton Global Distribution are not truthful, accurate, and are potentially misleading.


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