FDA Sends Warning Letter To Golden Caviar

The Food and Drug Administration (FDA) has taken issue with Golden Caviar Skin Care after reviewing its website in April 2015.
 
In the letter FDA cited the Irvine, CA-based firm’s topical products,  “Alpha Arbutin Cream (Whitening Cream),” “Bio Whitening,” “Caviar Lifting & Firming Serum with Zinc,” “Heal & Conceal,” “Redness Calming Serum as well as four dietary supplements.

According to FDA, Golden Caviar’s website promotes these products for conditions that cause the products to be drugs under the Federal Food, Drug, and Cosmetic Act (the Act). In addition, FDA said the products are misbranded under the Act.
 
Claims on the firm’s website indicate that the topical products are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body, rendering them drugs under the Act.
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
Alpha Arbutin Cream (Whitening Cream)
 
•  “[H]elp get rid of dead skin…”
•  “Reduces and prevents hyper-pigmentation…”
•  “GREAT for reducing acne and acne scars!”
 
Bio Whitening
 
•  “[H]elps to stop the formation of melanin pigment…”
•  “[H]elp to exfoliate dark surface cells…”
•  “Lightens skin Blocks and inhibits tyrosinase activity Limits melanin production Reduces redness (erythema).”
 
Caviar Lifting & Firming Serum with Zinc
 
•  “It helps repair damaged tissues and heal wounds. Great for anyone wanting to do away with old acne scars or suffering from Rosacea…..We have found the solution.”
 
On the FAQ Page:
 
•  “The most effective products for skin elasticity and wrinkles are found in our Caviar Lifting Serum. “Mini Botox in a Bottle”
 
Heal & Conceal
 
•  “[A] natural antiseptic and antibacterial…”
•  “[E]nhance the healing process by reducing inflammation…”
 
Redness Calming Serum
 
•   “[A]nti-inflammatory properties”
•  “[G]reat for those with psoriasis.”
 
The Alpha Arbutin Cream (Whitening Cream),” “Bio Whitening,” “Caviar Lifting & Firming Serum with Zinc,” “Heal & Conceal,” and “Redness Calming Serum,” are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are new drugs as defined in 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 section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 
 
Furthermore, FDA said the “Caviar Lifting & Firming Serum with Zinc,” and “Redness Calming Serum” products are offered for a condition that is not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
In addition, FDA said that “Golden Caviar” products are misbranded within the meaning of section 502(a) of the Act [21 U.S.C. § 352(a)] in that the labeling is false and misleading in any particular. Specifically, on the company’s FAQ page, it says: “All of our products are FDA approved in FDA approved laboratories.” However, FDA has not approved these products and FDA does not approve laboratories. In addition, FDA does not approve cosmetics or dietary supplements.