The global personal care products industry is currently valued at USD 13.2 billion approximately and is expected to grow furthermore in the coming years. With the increase in numbers, the United States Senate has proposed a Personal Care Products Safety Act, a bill, to strengthen the regulations of ingredients of personal care products and protect consumer health.
While the Food and Drug Administration (FDA) is responsible for overseeing the personal care products in the United States (US), it does not regulate the ingredients involved in the manufacturing process. Therefore, the agency cannot recall these products, in case of adverse effects. To overcome this, the FDA is taking a step closer to enhance the safety of consumer health by regulating the ingredients used in the manufacturing of these products more strictly.
Safety of Ingredients
The regulations of cosmetics and personal care products’ ingredients will be upgraded for the first time in the last 80 years. Cosmetic Ingredient Review (CIR), an expert panel, was initially instituted to review cosmetic ingredients independently. The panel has expressed concerns over the usage of high concentration of certain ingredients in personal care products. The concerns of the panel increased radically after reports of negative health effects were received.
One of the major concerns was that while some of the ingredients are safe to use at a low concentration level, using them at higher concentration may harm consumer health.
Personal Care Products Safety Act
As per the Personal Care Products Safety Act, the FDA will be required to evaluate at least five ingredients of a personal care product every year. The purpose of the Act is to determine the safety of personal care products and their usage. The review process, as per the bill, gives a concrete guidance to the manufacturers regarding the usage of ingredients, i.e., if they should be used or not or if consumer warnings are required. The set of chemicals which should be reviewed first are:
- Preservatives (Diazolidinyl urea, Propyl paraben, Quaternium-15) used in a variety of products such as shampoo, lotion, deodorant, conditioner, etc.
- Binding agents (Diethyl phthalate) used in cosmetics and fragrances.
- Ingredients (Methylene glycol/formaldehyde) used in products for hair treatment.
Role of the FDA
Once the Act comes into effect, it will give the FDA authority to:
- Recall personal care products which may pose a threat to the consumer health
- Require labeling for products which consists of ingredients considered to be inappropriate for children and should be administered by professionals
- Ask the manufacturer to publish the complete labeling information (including ingredients and warnings) online
- Ask the manufacturer to provide contact information for consumers to report any adverse event; manufacturers are also required to report the serious adverse event cases to the FDA within a span of 15 days
- Require the manufacturers to register with the FDA annually to provide the information of the ingredients used in the manufacturing of the products
- Issue regulations regarding the Good Manufacturing Practices (GMP) of personal care products
The Act also authorizes the FDA to collect user fees from manufacturers of personal care products in order to fund the above-mentioned activities. The CIR has also confirmed to support the FDA with the same by providing accurate safety assessment reports and relevant data.
How will the bill impact the personal care products industry? This question can be answered only once the bill is passed. Keep abreast with Regulatory information and updates. Stay tuned. Stay compliant.