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.

• 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.

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

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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The study was performed by the University of Surrey and involved the irradiation of subjects with whole-body blue light at 450nm, roughly comparable to that of a dose of sunlight. Unlike its cousin ultraviolet (UV) light, blue light is non-carcinogenic and does not share the potential cancer-causing concerns. The results of the study showcased a significant decrease in systolic blood pressure comparable to the effects seen with medication targeted to have similar effects for those with hypertension.

A surprise to the unassuming consumer, blue light’s reputation may see a shift from positive to negative as more and more studies are aimed at finding natural treatments to common physical ailments and shortcomings. A potential solution to those who are difficult to treat with oral pill form solutions for hypertension, this study showcases a potential solution to a common disorder that affects hundreds of thousands of people each year.

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 An Unsung Hero: Could Blue Light be the Answer to Hypertension? appeared first on Focal Point.

Cosmetovigilance can be described as the careful post-market surveillance of cosmetic products after they have been made available to consumers.  More simply put it can be defined as monitoring cosmetic safety.  Similarly to the concept of pharmacovigilance associated with drugs, cosmetovigilance employs the principles of post-market monitoring to keep record of adverse reactions to products. Monitoring these unintentional and un-desirable effects is a key aspect of successful marketing of these products.

What is the importance of cosmetovigilance?

Cosmetovigilance is especially important because the safety and clinical trial testing of cosmetic products are under less scrutiny by regulators than other products such as drugs, natural health products and medical devices.  This makes monitoring and reporting observed adverse effects important. There are no forms of pre-market approvals for cosmetic products in the United States or Canada (with the exception of batch certification of certain colour additives in the US), allowing these products to be easily introduced to market. The effectiveness and safety of cosmetics are entirely left to the discretion of the manufacturer, which may include testing, but it is not a requirement. As such, proper incident reporting post-market is of the highest importance. With a proper system in place problems can be identified early and changes made, limiting the size of the population affected.

Where does the responsibility to uphold/enforce cosmetovigilance fall?

The responsibility to ensure that a safe product is being marketed falls upon the manufacturer. They should be aware of risks, if any, associated with their product before releasing it into market place and if needed make consumers aware of these risks.  When it comes to the reporting of adverse effects from the use of a product the responsibility falls both on the manufacturer and the consumer. Throughout the years, cosmetovigilance has proven to be a vital tool for protecting consumers from negative side effects of products.  A common product in Asian countries, skin lightening creams have had an increase in popularity in recent years.  Lighter complexions are seen as true beauty in these regions, leaving consumers willing to do anything to achieve the ideal complexion.  Risky but effective, there are many different products on the market capable of being used to help accomplish this, from creams and gels all the way to injections (considered as illegal drugs). However, some of the raw materials contained in these products can be dangerous and have permanent damage to internal systems. One concerning additive in question in these formulations is mercury. Mercury is banned from cosmetics in nations such as the European Union and other nations such as the US and Canada have strongly enforced concentration limitations.  Despite wide scale bans, mercury is still popping up in formulations and these dangerous products are being smuggled into countries or sold online. The use of these mercury-containing products also does not solely affect the individual using it. Traces of this dangerous substance can easily be passed to unsuspecting bystanders that encounter that individual and even into water supply. In 2016 the FDA stressed the importance that these products stop being used. Without proper post market evaluation, investigation and regulation its possible that many of these products would be remain easily accessible to consumers, contaminating their homes and more importantly their bodies.

What effects can proper cosmetovigilance have on industry?

Keeping track of adverse effects from cosmetics is what can often lead to certain ingredients being restricted or prohibited by regulators. Manufacturers may even choose to pull a product from shelves if an increasingly high number of complaints is received. If consumers are seen to experience sensitising effects from certain ingredients the rules surrounding that ingredient may be amended. In short, without proper cosmetovigilance, vital changes to both product availability and regulation would be less frequent.

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 Cosmetovigilance: Safety in Cosmetics appeared first on Focal Point.

Pharmacovigilance is defined by the World Health Organization as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem”. In simpler terms, pharmacovigilance can be defined modestly in two words, drug safety. The study of drugs and their associated risks and effects does not simply end after lengthy studies and clinical trials.  Long after their development phase it is important that their ongoing effects and interactions with consumers continue to be monitored.

What is the importance of Pharmacovigilance and what are its effects?

A necessary step for not only prescription drugs but those less heavily regulated like OTC drugs, pharmacovigilance helps to monitor the safety of these products after consumer consumption. Recently, it has been seen that the FDA is choosing to crackdown on the safety of certain medications.  It was reported by USA Today that the FDA had begun an intensive investigation into certain blood pressure medicines with suspicions of contamination by cancer-causing impurities. These further investigations are essential to ensure the safety of consumers. With recall of medications that exhibit serious side effects or signs of contamination, the health and safety of consumers can be protected.

What is the Importance of Adverse Reaction Reporting to Pharmacovigilance?

A key aspect of pharmacovigilance is adverse drug reaction reporting. A strong determining factor in the longevity of products in market place, the reporting of these reactions is pertinent to maintaining consumer health. Without adverse reaction reporting, products that are otherwise unsafe for consumers may slip through the cracks and be left accessible to more consumers. No truer example of its importance, the 1960s thalidomide disaster that resulted in severe birth defects is a prime example of the importance of pharmacovigilance. Originally prescribed to treat morning sickness in pregnant women, this drug was seemingly harmless. Without a proper recall of this dangerous drug more and more unsuspecting expecting mothers, would have been susceptible to traumatic effects of this drug. In fact, it was this disaster that further spurred Health Canada to more tightly regulate and monitor prescription drugs and their release into marketplace. Proper regulation before and after market of drug products can ensure that disasters like this one do not occur.

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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