As I continue more into my public ministry of educating the public about natural health, I’m always mindful of the work that I do in my 9 to 5 as a Clinical Research Scientist. Before any drug comes to market, it must be clinically tested to show the efficacy and safety by the FDA. I have worked in Drug Research for over 18 years and am intimately aware of the consequences of not following the guidelines by the FDA. So I use the same wisdom ,caution and protection of others from clinical trials as I formulate new cosmetics.
The growth of the internet has created many new skillful formulators. You will be hard-pressed these days not to find some one giving advice, instruction and recipes of natural products on FB, Youtube, Periscope and Blogs. Many companies (like me) have started in their kitchens without the proper education on safety, efficacy and good manufacturing guidelines. While you do not have to possess a degree to create a good product, the ability to stabilize and provide product safety does require education. My formal training in drug research did not adequately prepare me for cosmetic formulation. I had to go and obtain education, training and certifications to ensure product efficacy and safety. It is why I created a formulation class. It is to teach novices how to create professional products.
The FDA does not approve cosmetics. The FDA only approves drugs and medical devices. However, under the Cosmetic Act, there is consumer protection. Recently, I started a brand, “Organic Sista” dedicated to providing education and truth to natural products in general. My advisory board is a group of experts in the field of hair, skin, nutrition and lifestyle. Each of these people will lend their professional know-how to educate the public on what is truly organic and natural while providing a truly unbiased opinion. Sadly, many are following the advice of bloggers, vloggers and do-it-yourselfers who have no formal education on their subject. I recently, came across a youtube video where, a vloggers was suggesting putting Monistat in your hair. A vaginal yeast infection in quite different from conditions on the scalp. This is where the lines are blurred. I don’t disagree with natural remedies, however, without clinical data or proven data , one can’t determine the effectiveness. Therefore, we should be selective in what we say a product can or can not do. Not all scalp conditions are yeast. Therefore, recommending someone to use this on their hair is ridiculous, given the other ingredients in Monistat. There is no reason to circumvent the doctor, the salon stylist, the dermatologist etc when it comes to your health and well-being. Somethings should be left to the professionals.
To provide to light to my concerns, recently the FDA placed a warning to consumers on a popular product. Please see below directly from the FDA’s webpage. Placing labels on your product that state your product cures, treat, heals makes that product a drug and not a cosmetic. This is a wake up call to all those who have natural products that are being massed produced. Mass production does not mean a quality product. Many of these products are popular due to branding and not effectiveness. How many of us a purchased products because a celebrity or well know person has endorsed it? Usually many of these people are paid to say how good the product is. I’m not sure what happened with Alikay Naturals, but this will not be good for their branding. Alikay Naturals does not make betonite clay, but it is an ingredient that they use in their products and that I use in mine. This could be very innocent on their part and I believe that it is. This report goes out as a warning only. It does not state that lead was found in their products which disturbs me. But, once you put it on the label as a benefit to a body organ, it becomes a product that can be investigated by the FDA as a potential drug. So let this be a warning to all who are creating products with false claims. The FDA is watching. I should know, I have to comply with them daily in my job as Clinical Research Scientist.
The U.S. Food and Drug Administration is warning consumers not to use “Bentonite Me Baby” by Alikay Naturals because of a potential lead poisoning risk.
“Bentonite Me Baby” is sold online and in retail outlets, including Target stores, Amazon.com, and Sally Beauty Supply, and is marketed as medicinal clay. The product’s labeling indicates that it can be ingested and applied topically to hair and skin for a variety of conditions.
Consumers should not purchase or use “Bentonite Me Baby.” Anyone who has used this product or provided it to a child should consult a health care professional immediately.
FDA laboratory analysis of the product found elevated lead levels. Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system. In children, chronic exposure to lead, even at low levels, is associated with impaired cognitive function, including reduced IQ, behavioral difficulties, and other problems.
FDA learned that this product may contain lead from the Minnesota Department of Health. FDA has not confirmed any cases of lead poisoning associated with the product.
Health care professionals and consumers are encouraged to report any adverse events potentially related to “Bentonite Me Baby” by Alikay Naturals, or any other alternative medicines, to FDA’s MedWatch Adverse Event Reporting program by:
- Completing and submitting the report online atMedWatch Online Voluntary Reporting Form
- Downloading and completing the form, then submitting it via fax at 1-800-FDA-0178