Regulatory and legislative activity can result in significant business impact within the cosmetic and personal care product industry. Compliance is not just a hurdle to be dealt with and forgotten. Non-compliance can be costly: consumer safety can be compromised and enforcement activity from regulators can directly impact the bottom line. In addition, class-action lawyers in some states represent an ever-present threat to business. The Independent Beauty Association publishes this information as soon as we can so you have enough time to comply.
The following is a roundup of some regulatory topics that could directly impact your business. Whether or not all of these apply to you, that's for you to determine (or we can help). However, we present them all because non-compliance can result in lost time and money.
Hand Sanitizer Manufacturing—FDA Withdraws the March 2020 Temporary Guidance Documents
In order to help increase the supply of hand sanitizers to meet the demands of the beginning of the COVID-19 pandemic, FDA issued temporary guidance documents in March 2020 that allowed for manufacturers who were not already drug manufacturers to make alcohol-based hand sanitizers according to specific instructions. On October 13, 2021, FDA announced that these guidance documents will be withdrawn effective December 31, 2021.
- December 31, 2021: Production of alcohol-based hand sanitizers authorized under the temporary guidance documents must stop. (Production of hand sanitizers under the monograph may continue.)
- March 31, 2022: Products produced under the temporary guidance documents may no longer be sold to wholesalers or retailers. (Product produced under the monograph may continue to be sold).
What does this activity mean for hand sanitizer manufacturers and distributors?
QUESTION: My company has produced alcohol-based hand sanitizer under the temporary guidance documents but does not want to become a drug manufacturer. What do we need to do?
- Stop manufacturing hand sanitizer products by December 31, 2021
- Stop selling product to wholesalers or retailers by March 31, 2022
- Update your product registrations to "delist" the products from eDRLS
- Update your facility registration to "deregister" your establishment in eDRLS within 30 days of stopping
- Deactivate your Labeler Code if your company is no longer going to be manufacturing OTC drug products
To request additional assistance with deregistration and delisting, please contact email@example.com
QUESTION: My company wants to continue to make hand sanitizers after December 31, 2021. What do we need to do?
- Your facility will need to be listed as a drug establishment in eDRLS
- Your facility will need to be compliant with FDA's Current Good Manufacturing Practices for drug products
- Your products will not be limited to the formula constraints detailed in the temporary guidance documents, but they will need to comply with the tentative final monograph for over-the-counter topical antiseptics
- Your OTC products will need to be listed in eDLRS
- Your facility will be obligated to pay annual OMUFA user fees
Important New Reporting Requirement for OTC Drug Manufacturers
The March 2020 CARES Act included a requirement for annual reporting on the amount of each listed drug product that was manufactured, prepared, propagated, compounded, or processed for commercial distribution. Over-the-counter drugs, like sunscreens, anti-acne products, and skin protectants, are covered by this reporting requirement.
This reporting requirement is new and has not yet been implemented by FDA. The most recent step FDA took toward implementation was the publication of a Draft Guidance Document, which was distributed for public comment.
COMMENT DUE DATE:
- December 29, 2021
ACTION: If your organization is a stakeholder in OTC product manufacturing, your team should read the recently published draft Guidance Document and Technical Conformance Guide to understand the new reporting obligations.
New California Bill Changes Wipes Labeling Requirements
A new bill was passed in California this week requiring certain premoistened disposable wipes manufactured on or after July 1, 2022, to be labeled with the phrase "Do Not Flush" and the symbol included here. The bill prohibits certain claims about flushability. Enforcement provisions include civil penalties up to $2,500 per day, up to a maximum of $100,000 per violation.
Covered products include products that are "Likely to be used in a bathroom and has significant potential to be flushed, including baby wipes, bathroom cleaning wipes, toilet cleaning wipes, hard surface cleaning wipes, disinfecting wipes, hand sanitizing wipes, antibacterial wipes, facial and makeup removal wipes, general purpose cleaning wipes, personal care wipes for use on the body, feminine hygiene wipes, adult incontinence wipes, adult hygiene wipes, and body cleansing wipes."
ACTION: Evaluate your portfolio now to determine products in your assortment that will be impacted by this bill and begin to implement labeling updates where necessary.
It is important to confirm package compatibility when moving to PCR materials. Initiate package compatibility studies as early as possible in case there are issues that need to be resolved.
Reminder: California Cosmetic Fragrance and Flavor Ingredient Right to Know Act—Deadline Approaching!
The Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 (CFFIRKA) requires companies to report products with specific fragrance and flavor ingredients after January 1, 2022. This reporting requirement does not include changes to labeling. Companies will use the existing California Safe Cosmetics Reporting Portal for CFFIRKA submissions. Learn more about CFFIRKA compliance information here.
Effective Date: January 1, 2022
ACTION: Evaluate your formulas to identify any products that will require notification prior to the effective date. TIP: IBA recommends signing up to receive CDPH updates about any changes to the program or to the list of reportable ingredients.
California DTSC Taking Action on Nail Products Containing Toluene
If your organization is a stakeholder in nail products containing toluene, there is activity in California that your organization needs to follow. The California Department of Toxic Substance Control (DTSC) is considering proposing rulemaking that would regulate nail products containing toluene under the Safer Consumer Products regulations.
ACTION: Assess whether proposed rulemaking for toluene containing nail products could have an impact on your assortment. Stakeholders in this category should watch this activity closely and engage with DTSC staff to ensure decision making is made with accurate, science-based information.
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