In addition to compliance assistance with the new Food & Drug Administration (FDA) Modernization of Cosmetics Regulation Act (MoCRA) of 2022, SRC offers compliance support for cosmetic ingredient disclosure and reporting requirements for the California Safe Cosmetics Act of 2005 (CSCA) (and the Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 (CFFIRKA) (Senate [...]
SRC monitors industry trends through frequent communication with regulating agencies, and review of warning letters and enforcement actions. From our monitoring of FDA Warning Letters, we have noticed some recent trends in FDA enforcement and interpretation of the regulations of over-the-counter drugs. Bob MacDonald, SRC’s VP of Regulatory Services provides a breakdown of these trends. [...]
On Friday, February 24th, the U.S. EPA issued What You Need to Know About Producing, Distributing or Selling Pesticide Devices, a Compliance Advisory explaining how FIFRA regulations apply to pesticidal devices. EPA defines a pesticidal device as "an instrument or contrivance that is intended to destroy, repel, trap, or mitigate any pest, including but not [...]
Effective January 1, 2023, California’s Cleaning Product Right to Know Act (CPRTKA) requires intentionally added ingredients listed on Proposition 65 to be included in a designated product’s website and label disclosure. The Act allowed manufacturers to withhold from the label and website disclosure, such ingredients until January 1, 2023 (Note: website disclosure of nonfunctional constituents [...]
U.S. EPA and many states and territories have adopted more stringent limits for Volatile Organic Compounds (VOC) in consumer products. While newer limits have already taken effect in some states (or for certain product categories), the effective date for others is quickly approaching. New VOC limits for specific product categories in California and New York [...]
On October 7th, EPA released its new Guidance for Products Adding Residual Efficacy Claims. After a thorough review including a comparative review of historical documents and all linked methods, and the Response to Comments document, Scientific & Regulatory Consultants, Inc. (SRC) has created the below summary of changes. Registrants are being given a 1-year implementation [...]
Due to the ongoing Ebola outbreak in Uganda, the United States EPA has engaged its Emerging viral Pathogens Policy (EVP). The current outbreak of Ebola Virus Disease is caused by infection with Sudan ebolavirus. The first confirmed case was identified in a 25-year-old male in the Mubende District of Uganda on September 19th; though it [...]
UPDATE: The Maine Board of Pesticide Control has now set up a dedicated portal for submission of additional CSFs to ensure a secure method of transmitting these documents. Registrants should no longer email CSFs to Maine. Any CSF that was previously emailed to Maine does not need be resubmitted. In the below article, bolded red [...]
On August 1, 2022, proposed amendments to California’s Consumer Product Volatile Organic Compounds (VOC) Regulations were approved by the Office of Administrative Law and filed with the Secretary of State. These amendments are a result of the California Air Resources Board’s (CARB) efforts to reduce VOC emissions from consumer products, which CARB states are the [...]
On January 8, 2021 OEHHA issued notice of proposed rulemaking to amend sections 25601, 25602, 25603, and 25607 of Article 6 of the Safe Drinking Water and Toxic Enforcement Act of 1986 in the California Health and Safety Code (Proposition 65 Clear and Reasonable Warnings). The proposed rulemaking would limit the use of and modify [...]