,

Cosmetic Legislation Passed

Image courtesy of the White House

On December 23, 2022, President Joe Biden signed the 4,500 page Omnibus Spending Bill. Included in the bill is the “Modernization of Cosmetics Regulation Act of 2022” which updates the cosmetic sections of the Food Drug and Cosmetic Act for the first time in over 50 years. I’ve outlined the basic requirements of each new section below.

Over the next several years the FDA will go through the rule-making process to create detailed regulations to implement all of these new provisions of the Food Drug and Cosmetic Act.

Generally, all the provisions of the act will go into effect 1 year after it is enacted.

Small Business

The good news is that as a result of 14 years of hard work by the Handcrafted Soap and Cosmetic Guild and allied entities, there are provisions which protect small cosmetic businesses!

Thank you, HSCG, for protecting our interests!

Small business is defined as a business with less than $1 million average gross annual sales in the US for cosmetic products for the previous 3 year period.

To qualify, the small business may not manufacture cosmetic products that:

  • Come in contact with the mucous membrane of the eye (the surface of the eyeball and the inside of the eyelids)
  • Are injected
  • Are intended for internal use
  • Are intended to alter the appearance for more than 24 hours and removal by the consumer is not customary or usual.

Safety Substantiation

Applies to all cosmetic manufacturers.

Cosmetic products must have adequate safety substantiation

“Adequate safety substantiation” means tests or studies, research, analyses, or other evidence or information that is considered sufficient to support a “reasonable certainty” that a cosmetic product is safe.

“Safe” means that the product, including the ingredients, is not injurious to users when used as directed or as customary or usual.

The regulations to be issued will likely give more clarification. However, based on previous statements by the FDA, using only ingredients that are known to be safe is likely one way to prove safety. If you make products that use a preservative system, consider how to substantiate that the system is sufficient to keep the product safe and unadulterated.

Adverse Events

Applies to all cosmetic manufacturers.

Any serious adverse event MUST be reported.

A serious adverse event is defined as death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, an infection, or a significant disfigurements (such as serious and persistent rashes, second or third detree burns, significant hair loss), OR an event that requires medical or surgical intervention to prevent a serious adverse event.

This is new. Before this legislation cosmetic manufacturers were not required to report serious adverse events. This section applies to all cosmetic manufacturers.

Keep all records of any reported adverse events.

Small businesses (less than $1 million in sales) must keep records for 3 years. Larger businesses must keep records for 6 years.

Allow Inspections

If you have had to report a serious adverse event, you must permit an authorized person from the FDA to inspect your records.

Labeling

Applies to all cosmetic manufacturers.

Contact information for adverse event reports

The label must include a way to receive an adverse event report. It can be a domestic address, domestic phone number or electronic contact information (website or email). It appears that means that if the full street address is not on the label, then alternative (phone or electronic) method of contact must be provided.

This doesn’t look like it changes the current business name and address requirements (which are detailed in the Fair Packaging and Labeling Act). However, during the rule-making process it may be possible to get changes to the requirements for omitting the street address from the label.

This labeling requirement will go into effect in 2 years.

Fragrance allergens must be listed on the label

The FDA is being required to create regulations which say what fragrance allergens must be included on the label. They have 18 months to issue a notice of rulemaking, and 180 days after the close of comments to issue a final rule (so it will take about 2 years). In making the rules, the FDA is to consider existing international, state, and local requirements, including the existing EU rules.

In order to maintain global harmonization, in all likelihood, the regulations will end up somewhat similar to the EU requirements.

Good Manufacturing Practice

Small businesses are exempt.

Follow good manufacturing practices.

The FDA is being required to establish regulations for good manufacturing practices for cosmetics. This is similar to how food, drugs, and medical devices are handled. They must publish a notice of proposed rulemaking within 2 years, and publish final rules within 3 years. The rules must take smaller businesses into consideration.

Once the rules are in place, it will be prohibited to sell cosmetics that are made in a facility that is not in compliance with the good manufacturing regulations.

Business Registration and Product Listing

Small businesses are exempt.

Existing and new manufacturing facilities must register with the FDA.

Currently registration for cosmetic facilities is voluntary. This makes the registration required.

Facilities in existence now will have 1 year to register. After the first year, new facilities must register within 60 days of engaging in activity. Registrations must be updated within 60 days if there are changes. Registrations must be renewed every two years. There are some additional provisions which apply when a company’s cosmetics are manufactured by a contract manufacturer.

A cosmetic product listing must be submitted for each product manufactured

Cosmetic product listing are currently voluntary. This makes them required.

Cosmetic product listings for existing products must be submitted within 1 year. New products must be sumitted within 120 days of marketing the product. Any updates must be made annually.

A single listing submission for a cosmetic product may include multiple products if they only differ in color, fragrance, flavor or quantity of contents.

The FDA can suspend registration of a facility

The FDA can suspend the registration of a facility if they determine that there is a “reasonable probability” that product(s) produced in the facility may cause serious adverse health consequences or death. Once suspended, no products made in the facility may be entered into commerce.

There are a number of provisions for providing notice, allowing for hearings, and the like.

General Records Inspection

Applies to all cosmetic manufacturers.

The FDA will have rights to inspect records of cosmetic products

The FDA already has the right to inspect cosmetic manufacturing facilities if they “reasonably believe” that a product or the products manufactured in a facility could pose a threat of serious harm. Inspection of the RECORDS was not included in the previous law, so it is being added now.

Mandatory Recall Authority

Applies to all cosmetic manufacturers.

The FDA can REQUIRE that a cosmetic product is recalled.

Prior to now, the FDA only had the authority to request that a company voluntarily recall a cosmetic product. This gives the FDA the authority to require that a company cease distribution and/or recall a product if they won’t voluntarily do so.

There are a number of administrative procedures in the law, including notice, hearings and such.

Preemption

Preemption means that the federal law will supercede or displace the law of a lower authority.

No state may establish on continue in effect any law, regulation, order or other requirement for cosmetics that is different from or in addition to, or not otherwise identical with the provisions of this new law with regards to registration and product listing, good manufacturing practices, records, recalls, adverse event reporting , or safety substantiation.

This is actually a pretty big deal.

When it comes to cosmetics, most states have adopted state-level laws that essentially mirror the federal laws. There are a few states, however, that have implemented additional laws or regulations that address cosmetic facility registration, cosmetic product listing, and/or good manufacturing practices. Florida, in particular comes to mind. It will be interesting to see how it plays out.

Additional Requirements for the FDA

There are some additional requirements for the FDA.

Talc Testing

Within 1 year the FDA must propose regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing products. Final rules must be issued within 180 days of the close of the comment period. So they have about 2 years to come up with final rules.

PFAs

The FDA has been given the task of assessing the use and safety of perfluoroalkyl and polyfluoroakyls (PFAs) in cosmetic products . They have 3 years to publish a report on the FDA web site.


close

Sign up for my newsletter to get notifications of new blog posts and occasional newsletters with general information.

I don’t spam! Read the privacy policy for more info.

Like this? Please Share!
RSS
Follow by Email
Facebook
Twitter
Pinterest
LinkedIn

Discussion

15 responses to “Cosmetic Legislation Passed”

  1. Marina

    Hi Marie, thank you so much for all information! It’s very helpful. We have a question. Where (address) we should send our listing of cosmetic products and get facility registration number? They said that “the Secretary shall assign a cosmetic facility registration number and a cosmetic product listing number to each cosmetic product”. What would be address to send and is there any Form to fill out these information? Thank you for any help.

    1. Marie Gale

      The facility registration and product listings are currently through the Voluntary Cosmetic Registration Program (VCRP). It’s all done online. Right now, as the name suggests, it’s voluntary. There will probably be some modification when it becomes required, but from what I’ve read, it looks like those who are registered through the VCRP will convert into the “required” registration program. Registration and product listings will not be required for those with less than $1 million annual income (on 3-year average).

      1. Marina

        Thank you Marie, I was thinking about VCRP but I was confused by word “Secretary” in Act and FDA website did not mention anything regarding that new products (after signed this Act) shall be listed in 120 days…
        Thank you again for confirmation.

  2. is soap still NOT considered a cosmetic? what about sugar scrubs that are rinsed off? is my understanding correct, that the “loose” definition of cosmetic is that it stays on the skin? please clarify. mahalo!!

    (oops meant to replay to the blog, not the individual response so I’m posting again)

    1. Marie Gale

      The definition for soap is not changed. Soap is exempt from the definition of a cosmetic so long as it is the alkali salt of fatty acids (*lye/oil) AND is only marketed as “soap” (no other claims made).

      There is no “loose” definition of a cosmetic. A cosmetic is a product that is applied to the human body to improve appearance, beautify, or cleanse. Doesn’t matter if it stays on the skin (like a lotion) or it is washed off (like a scrub or soap) or if it is in contact in passing (like a bath bomb or shower steamer).

  3. Sharon

    What products are covered under this law?

    1. Marie Gale

      Cosmetics. That is, any product that is applied to the human body to cleanse, beautify, alter the appearance, or make someone more attractive. Perfume, bubble bath, scrubs, lotions, creams, eye shadow, any type of make-up, bath bombs, salves, lip balm, etc. Soap is a cosmetic UNLESS it is the alkali salt of fatty acids (lye/oil soap) AND it is marketed only as “soap”.

      1. Michelle

        Hey Marie!! Do you know if this mean Florida will HAVE to follow these new rules? So we are now able to make cosmetics without having to get a seperate facility and have it inspected, as long as our average gross sales for 3 years are less then 1 million? If so wow this is wonderful!!!

      2. Marie Gale

        Well, this is the implication of the pre-emption clause in the new federal legislation. How it will actually get implemented on a state-to-state basis is still up in the air. There’s nothing OFFICIALL one way or the other as of yet. It may have to get sorted out in the courts.

  4. Thank you so much for writing this detailed post! So important to spread the word. It will be a few very confusing years for creators.

    1. Marie Gale

      You’re welcome. And you are right, the next few years as the regulations roll out will be …. interesing.

  5. Kerry

    Forgive me for being ignorant but do you know if this means in Ohio we still need a lab to make cosmetics?

    1. Marie Gale

      At the moment there’s no information on how the preemption portion of the law will play out. Hopefully, it will clear the way for the Federal law to apply in Ohio, which should make life easier. But it may take some time.

  6. Joyce passmore

    As of now Kentucky is more strict than any other state with anything other than soap. Does this mean I can now make lotion if I keep meticulous records etc?

    1. Marie Gale

      The preemption clause indicates that the federal laws would take precedence over any state laws that aren’t the same. How that will actually work in the real world is not yet determined. Usually (at least from what I can tell) this sort of thing gets sorted out in the courts – which could take years.

      No doubt it will take at least a few months for the impact of this legislation to filter its way down to the state Attorney Generals and the agencies responsible for cosmetics. I think the BEST case scenario would be for the individual state agencies that have authority over cosmetics to just go, “Oh thank you! I can get THAT off my plate and concentrate on other more important safety issues like food and drugs!” Unfortunately, in my experience once a government has a power (like the agencies over cosmetics) they don’t usually want to give it up without a fight.

      Bottom line is that we will probably have to wait and see what happens over the next year or so.

      As a side note, if you have some experience with licensing in Kentucky, I’d very much like to hear about it. You can post here, or email me if you prefer (hello@mariegale.com).

Leave a Reply

Your email address will not be published. Required fields are marked *