THE LATEST FROM FOCAL POINT RESEARCH

Children’s Cough Medicine Under Evaluation

Children’s Cough Medicine Under Evaluation

The FDA’s Pediatric Advisory Committee met this week to discuss the use of children’s medications containing opioids, specifically codeine and hydrocodone, to treat cough. The meetings follow a warning in April against the use of codeine and tramadol medications in children under 12, as well as updated labelling for opioid products. The focus of the meeting was the use of prescription opioid products (specifically hydrocodone and codeine) for the treatment of pediatric cough, including current treatment practices and benefit-risk considerations. The Advisory Committee unanimously agreed that the risks of using children’s cough medicines containing certain opioids outweigh the benefits. The recommendation is part of ongoing efforts by the FDA to determine how and if opiates and opioids should be used in pediatric treatment. With the current FDA priority of reducing opioid abuse, the meeting also aimed to consider the broader public health implications of opioid availability. While the committee focused on the two age groups of 6-12 and 12-18, some participants questioned the benefit of focusing on age limits at all. The concern is that adolescent opioid abuse results from diversion to non-patients, rather than misuse of medications by the patients they [...]

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Going “Nuts” about Macadamia Nuts

Going “Nuts” about Macadamia Nuts

Choosing certain foods has long been linked to health benefits of heart disease reduction. Eating nuts as part of our diet is good for our heart. They are good sources of protein, omega-3 fatty acids, fibre and plant sterols, Vitamin E and fats. Yes, fats!! The unsaturated and saturated kinds. Recently, the US FDA ruled that the sellers of Macadamia nuts could make a qualified health claim that their product may reduce heart disease. In doing so, the FDA showed its willingness to consider the scientific evidence that the fats in these nuts, along with the other nut ingredients provide a health benefit. You see, most nuts are higher in unsaturated fats which is the preferred dietary fat to prevent clogged arteries. Yet, macadamia nuts have a higher percentage of saturated fats which have long been associated with higher total cholesterol and LDL cholesterol (bad cholesterol). This led researchers to conclude they may increase the risk of heart disease. However, many studies have not found this, and in fact, total and LDL cholesterol have been reduced. Previous data suggested that cutting down on dietary saturated fats was associated with a 17% reduction in cardiovascular events. Newer data is challenging that [...]

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New Guidance from Health Canada- Vanessa’s Law

New Guidance from Health Canada- Vanessa’s Law

This week Health Canada published two draft guidance documents regarding regulations falling under Vanessa’s Law. Also known as Protecting Canadians from Unsafe Drugs Act, Vanessa’s law amends the Food & Drugs Act through rules strengthening the regulation of therapeutic products, improving the reporting of adverse reactions by healthcare institutions. Vanessa’s Law is also intended to improve the ability of Health Canada to collect post-market safety information and take appropriate action on serious health risks.

Draft Guidance for Notifying Health Canada of Foreign Risk

The proposed amendment to the Food & Drug Regulations would require the holder of an authorization to provide the Minister with information regarding any serious injury to health of which the holder becomes aware, and is relevant to the safety of the drug, within 48 hours of receiving it, or becoming aware of it. This includes information regarding:
  • risks related to a manufacturing issue
  • risks related to a new contraindication or warning
  • changes to the labelling communicated to or requested by certain regulatory authorities
  • recalls conducted within certain foreign regulatory jurisdictions
  • reassessments of market authorizations, which resulted in a change to risk mitigation measures for a drug or the addition of enhanced vigilance requirements
  • the suspension [...]

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Importing Cosmetics into the U.S.

Importing Cosmetics into the U.S.

Foreign manufactured products make up key sectors of virtually every industry. In cosmetics, consumer demands for international products are largely driven by trends, and multicultural beauty needs. Whether you are importing cosmetics into the U.S., or exporting U.S. cosmetics to another country, you want to make sure that your products don’t get held up at the border. Here are a few tips to help make sure everything goes smoothly.

Importing Cosmetics

  The FDA works with U.S. Customs and Border Protection (CBP) to monitor cosmetic imports. Foreign cosmetics are subject to examination at time of entry into the U.S. by CBP. Products that are adulterated or misbranded can be refused entry and future products from the same importer may be targeted for examination. The most common problems with non-compliant cosmetic imports include:
  • therapeutic claims that would class the product as an unapproved new drug
  • labelling violations
  • microbial contamination
  • use of prohibited or restricted ingredients
  • color additive violations
Products that are refused entry must be brought into compliance, destroyed, or re-exported. All these options cost time and money so it is better tomake sure that your cosmetic products are compliant before they get to the U.S. border. Although cosmetic products and ingredients (other [...]

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Exporting Cosmetics from the U.S.

Exporting Cosmetics from the U.S.

Foreign manufactured products make up key sectors of virtually every industry. In cosmetics, consumer demands for international products are largely driven by trends, and multicultural beauty needs. Whether you are importing cosmetics into the U.S., or exporting U.S. cosmetics to another country, you want to make sure that your products don’t get held up at the border. Here are a few tips to help make sure everything goes smoothly. Exporting If you are exporting products to a country with different requirements for cosmetics, your exported product may not comply with the U.S. Federal Food, Drug, & Cosmetic Act or Fair Packaging and Labeling Act. However, there are several things you need to do to prevent your products being labelled and misbranded or adulterated:

  1. Make sure it meets the foreign purchaser’s requirements
  2. Make sure the product does not conflict with the laws of the country it is being exported to
  3. Label the outer shipping package to make it clear the product is intended for export
  4. Do not offer the product for sale in U.S. domestic commerce
It is the exporter’s responsibility to make sure that products are compliant with the regulations of the destination country. For information on a country’s regulations, [...]

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