The Numbers at a Glance

For FY 2026, the FDA has adjusted fees upward, reflecting an approximate 4.9% increase compared to the previous fiscal year.

Tier 1:

FY2026 – $587,529

(FY2025 was $559,777)

Tier 2:

FY2026 – $117,505 (FY2025 was $111,955)

The post FDA Announces Fiscal Year 2026 OMOR Fee Rates: Costs to Increase appeared first on Focal Point.

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.

This guidance is comparable to one which was published in 2014 concerning cosmetic products. For the sale of cosmetic products containing nanomaterial ingredients, the FDA published recommendations for safety assessments for cosmetics to address certain important factors including characterizations of the nanomaterial ingredient, the safety assessment of nanomaterials and considerations for its toxicology when developing cosmetic products containing nanomaterials.

This guidance, which was initially drafted in 2017 will be concerning the development of OTC drug products in which a nanomaterial is present in the finished dosage form. It should be noted that this guidance should be viewed as recommendations for monograph drug manufacturers unless specific regulatory requirements are cited.

The guidance highlights the need to obtain further understanding of the interactions of nanomaterials within the body, including both intrinsic and extrinsic factors, as well as how these attributes will impact the overall product quality, safety and efficacy. These considerations presented in this guidance include drug development, safety evaluation and quality considerations

The FDA proposes a risk-based approach when developing nanomaterial-containing drugs, with a focus on the following risk factors:

• Adequacy of characterization and function of the nanomaterial
• Complexity of the nanomaterial structure
• Understanding of the mechanism by which the physiochemical properties of the nanomaterial impact its biological effects
• Predictability of in vivo release based on in vitro methods
• Physical and chemical stability
• Route of administration

The information of the structure of a specific nanomaterial can be referenced within the appropriate letter of authorization as part of the drug application or to a drug master file. This is to ensure adequate characterization of the nanomaterial and understanding of the nanomaterial’s intended use and application. It should be noted that this list is not comprehensive and other risk factors may need to be evaluated during product development.

Moreover, as a guidance document, the information issued are considerations for the industry for drug manufacturers when submitting applications, including Investigational New Drug Applications, New Drug Applications, Biological License Applications, Abbreviated New Drug Applications and Drug Master Files. The FDA suggests that as the drug product development progresses, more information will be obtained about the nanomaterial and understanding will continue to be revised based on findings.

If you need any assistance or have any questions about whether this applies to your company or have any concerns, do not hesitate to contact us.

The post Final FDA Guidance for Drugs & Biologics Containing Nanomaterials appeared first on Focal Point.

As a DIN Owner, you should have received your Annual DIN Renewal package from Health Canada. These are due to be submitted by July 29, 2022. Should you require assistance with this, please reach out.

FDA User Fees For OTC Monograph Drug Facility

On June 1^st 2022, OTC Monograph Drug Facility User Fees for the fiscal year of 2022 were due to the US FDA. The fee for 2022 is $24,178 for facilities that manufacture or process a finished dosage form and $16,119 for contract manufacturing facilities. The annual facility fees for covered OTC drug facilities were introduced in 2021 to help fund FDA regulatory activities.

Facilities that are exempt from these fees include sanitizer manufacturers that distributed hand sanitizer products under the COVID-19 public health emergency as well as facilities that only manufacture active pharmaceutical ingredients, produce clinical research supplies, or conduct testing.

If you are unsure about whether your US-based drug facility has any fees due to the FDA, we can help determine which applicable fee applies to your establishment. Feel free to contact us.

Reminder for Drug Listings

Should you have any Drug Listing updates, now is a good time to file. If you require assistance, we are happy to help.

The post Reminders appeared first on Focal Point.

The state government aims to have this act become effective July 1, 2022. However, it should be noted that this bill has only passed the first reading in the house (on April 13, 2021). Since then, there has been no update. The bill must still undergo Referral to Committee and its Second and Third Readings prior to approval.

Since this bill has only passed the initial reading, there is no action needed as yet. However, once this act becomes effective, your company will be required to update your website if selling cosmetic products in North Carolina.

If you have any questions on this, please do not hesitate to contact us.

The post New Legislation for North Carolina appeared first on Focal Point.

Spoiler alert: The FY 2022 facility fees rates are an increase of approx. 19% in comparison to the FY 2021 facility fee rates.

Application fees are as follows:

• Monograph Drug Facility (MDF) Facility Fee – USD 24,127
• Contract Manufacturing Organization (CMO) Facility Fee – USD 16,119

The fees also apply to the submitter of OTC Monograph Order Request (OMOR) and is as follows:

• Tier 1 Monograph Fee – USD 507,021
• Tier 2 Monograph Fee – USD 101,404

The OTC monograph drug facility fees are due on June 1, 2022.

If you need any assistance or have any questions related to whether this fee program applies to your company or have any concerns about payment options, do not hesitate to contact us.

The post FDA OTC MONOGRAPH DRUG USER FEE RATES FOR FISCAL YEAR 2022 appeared first on Focal Point.

• Effective Dec. 31, 2021, you must cease all production of alcohol-based hand sanitizers.
• If you cease production of alcohol-based hand sanitizers, you must deregister.
• The deadline to sell any alcohol-based hand sanitizer produced on or before Dec. 31, 2021 is Mar. 31, 2022.
• If you wish to continue production, you may do so provided you comply with the OTC topical antiseptics tentative final monograph and other requirements, including FDA cGMP.

If you would like further information on this, please do not hesitate to contact us.

The post FDA Withdrawal of Temporary Guidances for Alcohol-Based Hand Sanitizers appeared first on Focal Point.

The FDA will provide companies with guidance on limitations and warnings needed when certain ingredients are incorporated in a product. Other powers brought forth by this bill includes authority over recall. If a company refuses to conduct a recall, the FDA will have the authority to issue recalls on any product that is likely to cause significant harm. 

Other highlights :

• Registration with the FDA, disclosure of ingredients and attest to safety records 

• Must report adverse events within 15 days and annual reporting of all reported adverse health events

• banning of products that intentionally contain the harmful chemical PFAS (perfluoroalkyl or polyfluoroalkyl substances).

• Issuing regulations that will outline GMP for personal care products 

• Flexibility for small businesses 

• Website only business models will be required to provide full labeling including ingredients and warnings

• Authority to seize counterfeit products and seek civil penalties for any violations 

• State safety laws in effect prior to the date of enactment will remain in effect

• To collect user fees from manufacturers to help fund oversight activities

• This bill is being supported by many companies and associations

For more information on this article and to understand how this may affect your business’ day-to-day activities and future pipeline planning, please contact us

The post Senators Introduce Bill – Modernizing the Safety of Personal Care Products appeared first on Focal Point.

Does this apply to your company?

The facility fee for 2021 applies to any foreign or domestic facility engaged in manufacturing or processing a finished dosage form of an OTC monograph drug to be sold in the USA during the period between January 2020 and December 2020. This includes all facilities that perform the following business operations: finished dosage form manufacture, label, manufacture, pack, relabel, or repack. It also applies to submitters of an OTC Monograph Order Request (OMOR), except for those which request certain safety-related changes with respect to an OTC monograph drug. If your facility is solely manufacturing OTC hand sanitizer products, such a facility is not subject to the OTC Monograph Drug user fee program facility fee.

How much do you owe and when?

If you are an OTC monograph drug facility (MDF) – USD 20,322

If you are a contract manufacturing organization (CMO) – USD 13,548

If you submit a Tier 1 OMOR – USD 500,000

If you submit a Tier 2 OMOR – USD 100,000

Note: The above fees are for the period from Oct. 1, 2020 through Sep. 30, 2021.

Payment is due no later than May 10, 2021.

If you need assistance with determining whether the FDA OTC Monograph Drug user fee program applies to your company or you have any questions relating to payment options, please do not hesitate to contact us.

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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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