No. An ingredient’s source does not determine its safety. For example, many plants, whether or not they are organically grown, contain substances that may be toxic or allergenic. For more on this subject, see FDA Poisonous Plant Database. Under the FD&C Act, all cosmetic products and ingredients are subject to the same safety requirement: They must be safe for consumers under labeled or customary conditions of use (FD&C Act, section 601(a). Companies and individuals who market cosmetics have a legal responsibility to ensure that their products and ingredients are safe for the intended use.
Yes. The USDA requirements for the use of the term “organic” are separate from the laws and regulations that FDA enforces for cosmetics. Cosmetic products labeled with organic claims must comply with both USDA regulations for the organic claim and FDA regulations for labeling and safety requirements for cosmetics. Information on FDA’s regulation of cosmetics is available on our Cosmetics website.
The Agricultural Marketing Service of the U.S. Department of Agriculture (USDA) oversees the National Organic Program (NOP). The NOP regulations include a definition of “organic” and provide for certification that agricultural ingredients have been produced under conditions that would meet the definition. They also include labeling standards based on the percentage of organic ingredients in a product. For more information on “organic” labeling for cosmetics, see the NOP publication, “Cosmetics, Body Care Products, and Personal Care Products.”
If a cosmetic is labeled “organic” according to the USDA, is it still subject to the laws and regulations enforced by FDA?
No. FDA regulates cosmetics under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). The term “organic” is not defined in either of these laws or the regulations that FDA enforces under their authority.
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The following information is intended to respond to some questions consumers and manufacturers commonly ask FDA about “organic” cosmetics.
All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of their jurisdiction.
In light of the foregoing, the public is advised not to purchase the aforementioned violative cosmetic products. Moreover, the public is advised to always check if a cosmetic product is notified with the FDA through its website (ww2.fda.gov.ph). It has a Search feature which may be used by typing in the name of the product before deciding on purchasing and/or using the said product.
All concerned establishments are warned not to distribute violative cosmetic products until they have fully complied with the rules and regulation of the FDA.
Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including, but not limited to, skin irritation, itchiness, anaphylactic shock and organ failure.
The abovementioned products were verified by FDA through post marketing surveillance and shows no valid Certificate of Product Notification (CPN) as of 20 January 2021. Pursuant to Book II, Article I, Section 1 (a) of the Rules and Regulations Implementing Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization from the FDA is prohibited.
Since the abovementioned unauthorized cosmetic products has not gone through the notification process of the FDA, the agency cannot assure their quality and safety. The use of such violative product may pose health risks to consumers.
The Food and Drug Administration (FDA) warns the public from purchasing and using the following unauthorized cosmetic products.
In light of the above, the public is advised not to purchase the aforementioned violative products. Moreover, the public is also advised to be vigilant against cosmetic products that might not be duly notified with FDA. Always check if a cosmetic product has been notified with FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph.
FDA post-marketing surveillance (PMS) activities have verified that the abovementioned cosmetic products have not gone through the verification process of the agency and have not been issued the proper authorization in the form of acknowledged cosmetic notifications. Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.
Accordingly, because unnotified cosmetic products have not gone through the verification process of the FDA, the agency cannot guarantee their quality and safety. The use of such violative products may pose potential health hazards to the consuming public.
The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unnotified cosmetic products whose particulars/details are provided in the attached annex:
Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product or from the contamination of heavy metals such as mercury especially in whitening cosmetic products. The use of substandard and possibly adulterated cosmetic products may result to adverse reactions including but not limited to skin irritation, itchiness, anaphylactic shock and organ failure.
All concerned establishments are warned not to distribute the above-identified violative cosmetic products until they have already been covered by the appropriate authorization (cosmetic notification), otherwise, regulatory actions and sanctions shall be strictly pursued.
All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.