Much of the recent discussion regarding Prop 65 has been focused on the regulatory changes going into effect in August of 2018. And that makes sense since there will be significant changes to the warnings, responsibility, and labeling obligations on product websites. There is, however, other activity that may result in a more profound change as to which chemicals require Prop 65 warnings. As we have discussed in the past (see prior post here), there has been litigation in California state court addressing the appropriateness of adding the pesticide ingredient Glyphosate to the Prop 65 list. Continue Reading A Federal Court Gets Opportunity to Weigh In on Prop 65 With a Little Help from Some Friends
On December 6th, FDA announced that it is publicly releasing data received by the Agency’s Center for Food Safety and Applied Nutrition (CFSAN) about adverse events related to cosmetics and foods, including both conventional foods and dietary supplements. Adverse events can be any negative reaction to a product, such as a serious illness or allergic reactions, or other complaints like packaging problems, that are received through FDA’s voluntary adverse event reporting systems for these classes of regulated products (except for in the case of dietary supplement manufacturers, who have mandatory reporting obligations).
The CFSAN Adverse Event Reporting System, called “CAERS,” includes data from reports submitted by consumers, medical professionals, and industry. The initial data file made public by the Agency contains CAERS data from January 2004 through September 2016. Continue Reading FDA Increases Transparency of Adverse Event Data for Cosmetics and Foods
The CPSC has released the staff briefing package for a Notice of Proposed Rulemaking (NPR) to amend its existing regulation interpreting the requirements of Section 6(b) of the Consumer Product Safety Act (CPSA). Agency staff will brief the Commissioners on January 23rd and the Commission is scheduled to vote on the NPR on February 5th. It would not be surprising for the vote to be pushed back one or two weeks as the Commissioners consider the staff changes, develop their own amendments, and attempt to negotiate agreed upon language.
For those readers unfamiliar with Section 6(b), the statute requires the agency to take “reasonable steps” to assure that any information it intends to disclose to the public identifying a manufacturer or private labeler of a product (whether on its own initiative or in response to a Freedom of Information Act request) is accurate, that the disclosure is “fair in the circumstances” and is reasonably related to effectuating the purposes of the Acts administered by the CPSC. The statute also requires the agency to give companies at least 15 days advance notice and an opportunity to comment or object to the release of the information identifying them if they do not believe it meets the statutory criteria for release. The CPSC created a “fact sheet” some time ago that provides additional basics of 6(b) and answers common questions about the current requirements and procedures.
Among other changes proposed by the staff, the amendment proposes to: Continue Reading CPSC Releases Amendment to 6(b) Information Disclosure Regulations