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.

The bill will require businesses to take reasonable steps to ensure the sale of such products are not made to children under the age of 13. Suggested actions could include confirming the age of the purchaser before selling and putting up notices besides these products highlighting that they are not intended for anyone under 13 years of age, among other actions. Protecting young people, maintaining the freedom of choice and industrial innovation will turn out to be the deciding factors as AB 2941 works its way through the legislative process.

The post Assembly Bill 2491 – Banning the sale of anti-aging products to children 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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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.

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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.

• Register your 2020 tonnage with RPRA (Deadline to Register – October 1st)
• Pay your 2021 registry Fee when submitting your 2020 supply data
• Join a Producer Responsibility Organization (PROs)

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

The post Full Producer Responsibility for Post Consumer Waste in Ontario 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 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.

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

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