‘Hasty’ approval by FDA of cosmetic products bared
THE Food and Drug Administration (FDA) has apparently issued a new registration for a line of cosmetic products just a few days after cautioning the public not to buy them for being “misbranded,” engging in “false labeling,” making “unsubstantiated claims” and containing “misinformation on the products’ labels.”
Last September 28, 2020, Engr. Ana Trinidad F. Rivera, FDA director, Center for Cosmetics Registration and Research (CCRR), prepared a ‘Report of Violations’ (ROVs) against ‘Healthy Innovation Distribution,’ a company based in Santolan, Pasig City, to Atty. Emilio Polig, head of the FDA’s Legal Support Service Center (LSSC). The report details the alleged violations of FDA rules committed by the company.
The FDA last month conducted an investigation of Healthy Innovations’ facility where the alleged ‘mislabeling’ and ‘misrepresentation’ of its cosmetic products were uncovered.
The investigation, on the other hand, was triggered by complaints that the company was “deceiving” its customers by claiming that its line of ‘Sunglow’ and ‘Fresh Skinlab’ products contain between 30 to 50 ‘SPF” (sun protection factor).
However, results of independent third-party laboratories bared none of the products tested contain the amount of SPF as claimed in their labels.
Among those tested by third-party laboratories for Sun Protection Factor were:
‘Fresh Skinlab 98% Tomato Glass Skin Sungel with SPF50’; ‘Fresh Skinlab 98% Tomato Glass Skin Water Drop Cream With SPF30;’ ‘Sunglow By Fresh Tinted Lipscreen With SPF 50’; ‘Fresh Skinlab Tomato Face and Body Mist SPF50;’
‘Sunglow Fresh Sun Mist SPF50;’ ‘Fresh Skinlab Collagen Glow and Tone Face and Body Mist SPF50’ and, ‘Fresh Skinlab Aloe Vera Hydrate and Restore Face and Body Mist SPF50,’ showed all of them actually containing no SPF.
As a result, the FDA, beginning on September 11, issued several advisories warning the public from further buying the tested products.
Finally, last September 22, the FDA, issued FDA Advisory 2020-1738, which is a comprehensive warning to the public covering 50 cosmetic product lines being sold by Healthy Innovation.
The FDA said it issued the “public health warning” against the products after they were “verified” to be “non-compliant” during its conduct of “post marketing surveillance.”
Aside from the Sunglow and Skinlab product lines, also covered by the FDA warning are the ‘Hello Kitty’ and ‘Cherimoa’ brands, each consisting of three product lines.
Although Healthy Innovation filed an appeal with the FDA, insiders said the manner by which it was issued a new certificate of product registration (CPR) last October 1, by Rivera was “unprecedented” in the agency’s history.
They noted the new CPR came just a day after the ROVs against Healthy Innovation that Rivera earlier signed was received by the LSSC, or even before the issues raised by her report could be clarified and settled.
It was also learned that the new CPR for Healthy Innovation covers the products that are yet to be resolved by the LSSC and despite the absence of new laboratory tests submitted by the company to invalidate the test results made by the third-party laboratories.
Sources further stressed that “on average,” it takes between two weeks to one month before a new CPR is issued and the process takes much longer if legal questions, as in the case of Healthy Innovation, are involved.
