Personal Care Product oversight, finally !

As those in the personal care industry know the oversight for contents and recalls has been very limited as the regulatory laws have been the same since 1938.

 For the last 84 years not much has changed, until the upcoming new regulations set to start taking effect in December of 2023. When you think of personal care products include your makeup, skincare, haircare and other items that you apply to your body.

As part of the spending package Congress passed last year, there will be a new set of regulations that take effect in December of 2023. It’s called the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).  It significantly expands the US Food and Drug Administration’s authority regarding beauty and personal care products.

The real muscle of MoCRA is the ability of the Food and Drug Administration (FDA) to issue mandatory recalls of products they deem unsafe. Prior to this change, it was only able to request that companies issue voluntary recalls.  You might be aware that there have been some major lawsuits in the “beauty” industry. One of the highest profile cases recently is of course the 40,000 patients involved in lawsuits regarding Johnson and Johnson’s baby powder and their experiencing high uterine cancer rates.  Or perhaps you’re aware of the correlation between hair straighteners and uterine cancer?  These are but two of the ongoing issues with cosmetics that need additional oversight to make the industry safer for us all.

Changes:

Some other significant changes will be the requirement to engage in what’s known as Good Manufacturing Practices (cGMP). In many industries, these are and have been the law of the land for decades. Consider pharmaceuticals, foods, supplements, and medical product manufacturers as prime examples.

Mandatory allergen labeling which means that fragrance allergens will be printed on cosmetic labels along with facility registration with updates every two years will become the new standard. Along with these requirements, the products listing will now be required to include contact information for reporting adverse events, where the product was manufactured.

Along with these regulations manufacturers will be required to maintain records supporting what is termed “adequate substantiation ” that the product is safe. The way this will be interpreted is defined as “tests or studies, research, analyses or other evidence or information that is considered, among experts qualified by scientific training and experience, to evaluate the safety of the cosmetic product and their ingredients sufficient to support a reasonable certainty that a cosmetic product is safe”. The fly in the ointment is what constitutes “safe”.

The key to the provision is the FDA’s enforcement options should the product not meet this standard, as it will be classified as adulterated. This regulation will demand a much higher level of compliance

New provisions regarding adulteration are part of the new law. The new responsibilities of cosmetic manufacturers to substantiate safety will inevitably lead to more lawsuits however, it will also drive the movement toward verifiably safer products. 

One other consequence of this regulatory change will be the higher cost of compliance that will be passed on to the consumer. There will be a lessened level of requirements for firms that meet the “small” business definitions. So once again the onus will be on the consumer to understand which firms will meet all of the regulations and who is partially exempted.

Three State Regulations examples:

One of the problems with cosmetic regulations and laws in the US is the lack of commonality between state and federal laws with personal care products. This will continue as the  MoCRA does allow for state based regulation. In 2005 and starting with the enforcement in 2007 the California Safe Cosmetics Act of 2005 the state changed their requirement for cosmetics manufacturers requiring labeling of any ingredient that is on state or federal lists of chemicals that cause cancer or birth defects. In 2020, California passed the Toxic-Free Cosmetics Act which will take effect in 2025 and bans 24 ingredients known to be toxic, including mercury and formaldehyde, from beauty and personal care products sold in the state. Then also there is the Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 which has labeling requirements for fragrance allergens.  The state has now also passed a ban on PFAS in cosmetics, the PFAS-Free Beauty Act  which will ban the manufacture, sale, delivery, holding or offering for sale of any cosmetic product that contains intentionally added PFAS as of Jan. 1, 2025. Again, the concerns are in the fine detail as shouldn’t all PFAS’s be eliminated especially with our current level of knowledge and their health impact ?

In Washington state, the recent 2022 Chemical in Cosmetics Used by Washington Residents report made waves. Lead was found in foundations and lipstick. Formaldehyde was found in seven out of ten skin lotions, nine out of ten leave-in conditioners, and all ten hair styling gels. The result is a new  House Bill 1047  that would ban the sale, manufacture, and distribution of cosmetic products with a number of toxic chemicals in Washington, beginning in 2025. It should be noted that this is not the first-time similar bills have been unsuccessfully put forward. On the successful side, Washington state has banned phthalates in fragrance products.

In New York state the   Environmental Conservation Law (ECL) established a maximum allowable concentration of 2 ppm of 1,4 dioxane on December 31, 2022, and 1 ppm on December 31, 2023, for household cleansing and personal care products. However, the maximum allowable concentration of 10 ppm of 1,4 dioxane is allowed after December 31, 2022, for cosmetics. Recently a new bill SB 8291A has banned the use of mercury in cosmetics.

Safer Ingredients:

Cleaner functional ingredients have been in the pipeline of most cosmetic manufacturers for decades. The ongoing awareness of consumers searching for safe products has propelled the market to develop many new products.  For those interested in an inside view of the industry see these two publications;  Global Cosmetic Industry  and Cosmetics and  Toiletries  , it’s amazing how many changes are coming to this industry.

One of the challenges in this and other industries is the need to really understand the complete supply chain and employ scientifically valid testing methods to insure safe verified ingredients. This is then followed by manufacturing, distribution, and packaging processes that ensure the end product is, not unlike the ingredients, safe for use. When you consider the global nature of ingredients used in many cosmetics and personal care items this is a huge undertaking requiring significant infrastructure and capital.

The current labeling, substituting and use of questionable ingredients in our personal care products regardless of the current laws has failed to have us avoid any and all products of concern.  Reading labels is a start but clearly, the findings of the new Washington state report should reinforce your skepticism and make us all weary consumers.

At Pure Living, we think that beauty should never come at the expense of short-term or long-term health. Ultimately the goal is to make wise choices and minimize toxic exposures.  With the new forthcoming regulations, we will see a new level of opportunities to exercise our consumer awareness and vote with our dollars for safer personal care products

Take Aways:

Use the least number of cosmetics, as possible, to minimize your exposure

Talk to your legislators and insist on safer standards

Consider testing your body for toxins

Check the ingredients on all of your personal care products

Only purchase from reputable companies

Avoid the following short list of chemicals, there are more….