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 Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 (CFFIRKA) will be in effect starting Jan. 01, 2022. There are a total of 23 designated lists that contain ingredients of concern. If any of these designated lists are updated, companies will have 6 months to comply from the effective date.

The CSCP Reportable Ingredient List will clearly distinguish between fragrance allergens and other ingredients of concerns, since reporting requirements will be different. Fragrance allergens have unique reporting requirements and will often be determined by its concentration. For example, a rinse-off cosmetic with a fragrance allergen at or above 0.01% (100 ppm) or a leave-on cosmetic with a concentration at or above 0.001% (10 ppm) will need to reported. Any ingredients on the Reportable Ingredient List must be reported regardless of its concentration.

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

The post Jan. 01, 2022 – An Important Date for Cosmetics Sold in California appeared first on Focal Point.

If you would like further information on this or have any questions on how this may impact your business, please contact us. We are leading regulatory and quality consultants and can answer any questions pertaining to this.

The post Consultation on Upcoming Changes to NHP Labelling Regulations appeared first on Focal Point.

As of the Jun. 25, 2021 effective date, all new Acne products must follow the revised Health Canada monograph labeling requirements and for existing products, these should be in transition to ensure compliance with the new monograph.

For additional information on transitioning your products or questions you may have regarding this update, please do not hesitate to contact us.

The post UPDATED Health Canada Acne Therapy Monograph 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.

On April 14, 2021, Health Canada issued a letter to all MAHs to confirm the status of risk assessments and verify completion for all marketed, approved and dormant DIN products. A response is required by all MAHs by May 14, 2021 in the form of a ‘Risk Assessment Attestation Letter’. Subsequently, a ‘Summary of Completed Risk Assessments’ is due to be submitted to Health Canada by Jun. 01, 2021.

If your company has initiated, but not yet completed the risk assessments, Health Canada has asked for details on the actions completed to date, actions pending, details on the challenges you are facing in completing the risk assessments, and timelines on anticipated completion of risk assessments for all marketed, approved and dormant DIN products.

Should you, as a MAH, fail to respond to this request from Health Canada, or have not completed the risk assessments per the specified timelines, enforcement action may be taken following a referral to Health Canada’s Regulatory Operations and Enforcement Branch.

If you have any questions, please feel free to contact us.

The post Update on Health Canada Risk Evaluation of N-nitrosamine Impurities in Canadian Human Pharmaceutical, Biological and Radiopharmaceutical Products appeared first on Focal Point.

Talc is a naturally occurring mineral that can be found in a number of self-care products, including cosmetics, non-prescription drugs and natural health products (NHPs). The final assessment identified the following:

1. It may cause ovarian cancer when present in products intended for use in the genital area such as wipes, baby powder, diaper and rash creams, bath bombs, and genital antiperspirants or deodorants;
2. It is potentially harmful to your lungs if you breathe in loose powder products such as body, baby and face powders;
3. It does not present any health concerns if used in pressed powder products, dry shampoos, foot powders, products that come into contact with skin excluding the genital area and non-prescription products or NHPs intended to be ingested;
4. It is not harmful to the environment.

Talc is currently listed on the Cosmetic Ingredient Hotlist and is restricted in cosmetic products intended to be used on children. Given the results of the risk assessment, Health Canada is proposing further action to lower talc exposure from products that could be inhaled or used in products intended for the genital area. The proposed actions include:

• Adding talc to the Toxic Substances List in Schedule 1 of the CEPA – this would not restrict its use, manufacture or import, but rather enable the Government to take risk management actions under CEPA
• Changing existing entries on the Cosmetic Ingredient Hotlist and NHP Ingredient Database to include measures to reduce exposure to talc from products which may be inhaled or result in perineal exposure

Industry and other interested stakeholders are invited to participate in an electronic consultation on the proposed Risk Management Approach until Jun. 23, 2021.

If you have any questions or concerns or would like further clarification on the implications of the risk assessment and risk management approach, please feel free to contact us.

The post Tighter Restrictions to be implemented for Talc 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.

The post FDA OTC MONOGRAPH DRUG USER FEE RATES FOR FISCAL YEAR 2021 appeared first on Focal Point.

Phase I – Target Spring 2021 will include amendments to the Natural Health Product (NHP) Regulations to improve labelling of NHPs.

Phase II – Target Spring 2022 will include amendments to introduce for consultation a risk-based approach to regulatory oversight for non-prescription drugs such as expedited pathways for lower-risk products.

Phase III – To introduce for consultation, regulatory amendments to address evidence standards for similar health claims, extending risk-based regulatory oversight, and additional powers for Health Canada to require a recall or label change for all self-care products.

There will be an opportunity to provide comments on Phase I of the Self-Care Framework during the Canada Gazette, Part I, public comment period, which is expected to take place in spring 2021 and last 70 days.

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.

The post Phase I of the Self-Care Framework appeared first on Focal Point.

Why is this being done? To align with INCI names with REACH, and specifically the approach taken by the Hydrocarbon Solvent Producers Association and the OECD Guidance for Characterizing Hydrocarbon Solvents which describes hydrocarbon substances by the carbon range and the term “alkane.”. The update is expected to facilitate greater global harmonization of substance identification.

Companies will be allowed an indefinite period to fully transition to using the new terminology. Publication of the updated names in PCPC’s Infobase and wINCIis planned for spring 2021 in conjunction with the release of their new subscription database portal.

If you would like further information on the ingredients affected by this change, need assistance with making updates to your product labelling or filing Cosmetic Notification Amendments to Health Canada, please contact us.

The post Changes to INCI Names for Hydrocarbons appeared first on Focal Point.