Purpose and Scope:

The primary goal of this draft is to provide clarity to the industry regarding the FDA’s authority to access and copy records related to cosmetic products. Presented in a Questions-and-Answer format, the guidance specifically addresses three general topic areas:

• Section 605: Authority regarding Adverse Event Reports
• Section 610: Authority regarding Serious Adverse Health Consequences or Death (SAHCOD)
• Confidentiality and Refusal: Procedures regarding the protection of sensitive information and the refusal of access.

Regulatory Status:

Industry professionals are reminded that, like all FDA guidance documents, this draft represents the Agency’s ‘current thinking’. It does not establish legally enforceable responsibilities unless specific regulatory or statutory requirements are cited. Recommendations marked with the word should suggest practices rather than mandatory requirements.

Public Comment Period:

Stakeholders are encouraged to review the draft and submit comments

• Target Publication Date: January 22
• Where to Comment: www.regulations.gov
• Docket Number: FDA-2025-D-2243

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Based on mandatory industry filings, the FDA’s report offers a snapshot of how prevalent these “forever chemicals” are in the supply chain:

• The agency identified 51 different PFAS currently used across 1,744 cosmetic formulations.
• These ingredients are primarily added intentionally to enhance specific product attributes, such as water resistance, durability, and texture.
• The study concentrated on the 25 most common PFAS, which account for approximately 96% of the intentional use reported.

The Safety Verdict: Still “Inconclusive”

Perhaps the most critical takeaway is that the FDA was unable to make definitive safety determinations for the majority of the chemicals identified. The agency cited significant gaps in data and a lack of publicly available toxicological research as the primary reasons for this uncertainty.

While the report noted that five specific PFAS appear to present low safety concerns, at least one was flagged for potential safety issues.

Currently, there are no federal regulations explicitly prohibiting the intentional addition of PFAS to cosmetics in the United States. However, this report signals that scrutiny is increasing. The FDA maintains its authority to take enforcement action should specific safety risks emerge from the data.

Next Steps: Moving forward, the FDA plans to increase its monitoring and surveillance efforts. The goal is to reduce PFAS prevalence across the consumer product supply chain through expanded testing and resource allocation.

The post FDA Release: The State of PFAS in Cosmetics Under MoCRA appeared first on Focal Point.

With the two year mark of the portal’s December 2023 launch approaching, FDA is enhancing compliance support with new features that display real-time facility registration status and renewal dates, send automated renewal reminders, and provide updated user guides and tutorials.

Note – Cosmetic manufacturers and processors must renew their facility registration every two years from the date of initial registration. Companies can choose between Biennial Renewal (for registrations with updates) or Abbreviated Renewal (for no changes), with both electronic and paper options available. Early renewals are also permitted.

Deadlines are closer than you think. If you need guidance navigating Cosmetics Direct or completing your renewal, reach out to us and let’s get it done right.

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This proposal highlights the effectiveness of the OTC Monograph Order Request (OMOR) pathway. Initiated by a request from DSM Nutritional Products LLC, the FDA is proposing the inclusions of bemotrizinol at concentrations up to 6% without requiring a full New Drug Application. The FDA’s review confirmed that the ingredient meets high safety standards, offering broad spectrum (UVA/UVB) protection with low skin absorption and a favorable tolerability profile.

The FDA is currently inviting public feedback on this proposal via the OTC Monograph@FDA portal. If the agency ultimately concludes that bemotrizinol is generally recognized as safe and effective (GRASE), it will issue a final order formally adding the ingredient to he OTC Monograph M020.

The post 📢 FDA Modernization in Action: The Bemotrizinol Proposal & The Future of OTC Monograph Reform appeared first on Focal Point.

A 2021 study revealed that the detected fluorine levels in cosmetics could be a case of trace amounts derived from materials naturally occurring in the environment or resulting from the manufacturing process. This naturally occurring or unintentional presence of trace materials is recognized by the FDA and they offer guidance on the allowable levels. FDA plans to review such compounds and assures to publish a complete report on PFAs in cosmetics by Dec 29, 2025 as required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

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The portal is designed to simplify and expedite the registration process for facilities engaged in cosmetic businesses and for listing of products sold in the US. By providing a centralized platform, the FDA aims to enhance the efficiency of regulatory procedures, making it easier for industry professionals to comply with industry standards and guidelines.

The FDA has also extended the deadline for submissions, moving the compliance date from Dec. 29, 2023, to July 1, 2024.  If you require any assistance with filing your submissions via the Cosmetics Direct portal, please reach out to us. Our team is here to guide and support you through the process, ensuring a smooth experience for all stakeholders involved.

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While there is no published list of chemicals that meet the definition of PFAF, the statute requires any chemical containing at least one fully fluorinated carbon atom (a carbon atom on which all the hydrogen substituents have been replaced by fluorine) that is intentionally added to a product to be reported to the Department. Provided is a webpage of chemicals considered PFAS by the FDA, which, while not exhaustive, provides some clarity on what compounds are considered within the definition of PFAS.

Manufacturers impacted by this new legislation may request an extension if the presence of PFAS in their products is unknown and/or if they cannot provide sufficient information to meet the reporting requirements in Maine law by the reporting deadline.

Don’t hesitate to contact us if you have any questions about this update or would like our assistance determining if this new legislation could impact your products.

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Victor Gura, MD, an internist and nephrologist from Los Angeles, has invented a portable dialysis device that is designed to improve the overall quality of life of dialysis patients. In place of a 300-pound dialysis device, the WAK is worn on a belt and provides the benefits of daily dialysis without compromising normal routines.

How does it work?

The WAK is battery operated, which is a unique alternative to the current machines that require constant access to an electrical outlet. It features a unique concept that regularly eliminates fluid to reduce kidney strain, while also controlling blood pressure. The invention has developed from weighing 11 lbs to only 2 lbs and is connected to the patient using a single catheter, inserted under local anesthetic. This allows the patient to perform a multitude of activities while having dialysis, which would not have been remotely possible with the traditional dialysis methods. The first clinical trial filtered the patients’ blood effectively, regardless of whether their diet included salty or phosphorus-rich foods, which would normally be avoided for dialysis patients.

The later iterations of the product involved having a day mode device and a night mode device. This facilitates the ability to have a smaller device that could be used during the day and a heavier one for the night that performs clinical tasks and recharges the battery.

The U.S. FDA reduced the number of clinical trials that they wanted from five to two after the first clinical trial performed successfully in 2015. Although there was increased risk for blood clotting with this device, the benefits on patients’ quality of life became crystal clear and outweighed the risk.

If you require assistance with applying for a Class II medical device licence, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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CBD can originate from both cannabis and hemp plants. Although industrial hemp cultivation was legalized by the U.S. in 2018, the Food and Drug Administration considers CBD from either plant illegal as a food additive in consumer food products. “Until cannabidiol … is deemed safe as a food additive, the department is ordering restaurants not to offer products containing CBD,” according to a New York City Department of Health representative. The New York Post states that from July onwards, restaurants that violate this embargo could encounter fines of up to $650. New York isn’t the only state cracking down on cannabidiol in food products. Los Angeles, Maine, and Ohio are also enforcing state laws on CBD edibles and prepared foods.

Research has been done to demonstrate the potential that CBD has for treating anxiety-related disorders. Whether or not it has healing properties, cannibidiol is currently largely unregulated as a consumer product. Thus, it is difficult for people to truly understand what its’ intended effects are. Businesses also do not always explicitly outline the amount of CBD in menu items, or even which items contain CBD altogether, which is an immense regulatory and health risk. The lack of packaging and labelling requirements in the U.S. is what scares officials the most. Those who do not intend to consume edibles with cannibidiol may do so without knowing it.

As Cannabis laws changes rapidly, the future is unpredictable for the regulation of CBD in food products, although it might become legal in time to come.

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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A risk assessment is an integral part of maintaining both the health of Canadians and the environment. Risk assessments are executed by Environment and Climate Change Canada under the CEPA (Canadian Environmental Protection Act) and are used to “determine whether there are risks resulting from exposure of Canadians to the substance or releases of the substance into the environment, and the specific ways Canadians or the environment can be affected”. The assessment of chemicals allows for proper regulatory measures to be taken.

What risks does talc pose to human health?

The assessment mainly focuses on the risks talc poses within self-care products and concludes that it be classified as CEPA toxic. This conclusion is due to two associated risks with loose powder forms of talc. One of the two risks discussed is the inhalation of talc from loose powder products. This risk encompasses products such as baby powder and industrial applications in which talc is airborne. Warning labels have already been required on products like baby powder that are marketed for the use on infants, cautioning to avoid inhalation of the product by the infant. Inhalation of talc can lead to respiratory problems including “coughing, difficulty breathing, decreased lung function and scarring of the lung tissue”. Perhaps more serious of the risks is the possible associations with ovarian cancer. When used on the perineal region in women it was found that it is possible for talc to migrate and find itself lodged in the reproductive system. This judgement comes off the heels of the July verdict of the class action lawsuit of Johnson & Johnson by 22 women who claimed consistent use of J&J Baby Powder on the perineal area had led to their ovarian cancer (due to alleged contamination of talcum powder with asbestos). Johnson & Johnson was found guilty, with the court ruling in favour of those affected. Several studies have also been conducted to observe the possible risks associated with talc, these are included in the documentation provided by CEPA. It is important to note that, in pressed form or consumables (ie. Some cosmetics or foods or drugs), Health Canada did not find talc harmful.

Where does this leave Talc?

The findings show talc as a health threat, but that it presents no threat to the environment. In terms of talc as an ingredient in self-care products; those that are non-airborne, don’t come in contact with the perineal area or are consumed are deemed safe. However, in the meantime, consumers are left to make the decision themselves if they would like to stay away from talc-based products.

Despite these published documents, nothing is set in stone until the final assessment.  A 60-day comment period has opened allowing for comments to be made upon the presented information and conclusions. If passed, the proposed conclusions published by Health Canada would result in the following outcomes as means of risk management:

• Possible modifications to the Cosmetic Ingredients Hotlist to prohibit or restrict talc and its use in cosmetics and perennial products
• Possible modifications to the Natural Health Products Database and associated monographs to reduce the exposure of talc to consumers in NHPs and OTC drugs that have risks of being inhaled or usage associated with the perineal area

Important Dates to Note

• The draft screening assessment was posted online by Health Canada on December 5^th, 2018
• A 60-day comment period has opened and will close on February 6^th, 2019

For more information, please contact Focal Point Research Inc.  We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.

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