Categories
News

FDA’s Addition of the 9th Allergen (Sesame)

Sesame will become the 9th major food allergen officially recognized by the United States (FDA) on January 1st, 2023. The industry will have roughly two years to incorporate labeling changes to accommodate this new requirement. This clear labeling initiative is warranted to improve transparency, reduce allergic reactions, and protect this vulnerable population. 

Prevalence:

Sesame allergies are more common than one would think. Approximately 0.1% or 350,000 Americans experience allergic reactions or sensitivity to the ingredient sesame, thus justifying this major change and the addition to the Priority Allergen List (PAL). Symptoms from sesame reactions can range anywhere from hives to anaphylaxis and can even be potentially fatal to some individuals. 

How to disclose allergens:

Mislabelling or misrepresentation of an allergy is a serious issue and can lead to enforcement action for your product. The proper format(s) to disclose a major allergen on food labeling in the United States is as follows:

In parentheses following the name of the ingredient. Examples: “lecithin (soy),” “flour (wheat),” and “whey (milk)”

or

Immediately after or next to the list of ingredients in a “contains” statement. Example: “Contains wheat, milk, and soy.”

Exceptions:

When this new change comes into force, sesame must appear clearly in the ingredients listing. However, sesame will not be required to be listed if it is within a spice or flavoring. It will also not need to be listed when sesame is assumed within the common or usual name of a food (e.g. Tahini is made from sesame seed). It is important that consumers are aware of any allergens within their foods at the time of purchase. Taking precautions and clearly labeling your ingredient can help save lives. The industry is urged to transparently disclose sesame wherever possible. Taking an honest approach is always suggested when it comes to allergens. 

Other names for sesame are Benne, gingelly, seeds, sesamol, sesamum indicum, sim, tahini, and til. It is important that these ingredients will now be called out clearly as providing sesame to avoid where possible, any confusion, allergic reactions, and potential hospitalizations. 

Enforcement:

The FDA can enforce incorrect allergen labeling similarly to an adulterated or misbranded product. They can take actions such as warning letters, recalls, import refusals, or product seizures. In most cases where incorrect labeling has been identified the company can and will recall the product voluntarily. The seriousness of incorrect labeling can be fatal and should be taken very seriously.  

International Recognition:

Sesame is a recognized priority allergen in many major markets such as Canada, the EU, and now the USA. Sesame is the largest food allergy in Israel and its commonality is spreading. 

Allergens:

The original/other eight major US allergens are Milk, Tree Nuts, Eggs, Peanuts, Fish, Wheat, Shellfish, and Soybeans.

How Quality Smart Solutions can help:

Please contact our team for more information on labeling of allergens, or other food labeling projects. Our specialists are here to help!  

Resources:

www.fda.gov

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

30 Minutes Free Consultation
Categories
News

Coming into Force: Human Milk Fortifiers Regulations

After consultation with stakeholders and based on a noticeable lack of current regulations and need for availability and innovation for these types of products, Health Canada has released new Directives/Guidance Documents and Publications in Canada Gazette part II. These articles pave the way for new regulatory requirements and now list Human Milk Fortifiers (HMFs) within the Food and Drugs Regulations

This framework will enhance the ability of industry to add vitamins, minerals, and amino acids to human milk, in turn, providing infants with these important nutrients. These types of products are commonly administered to premature and low birthweight infants, bolstering the benefits of human milk to aid in growth and development.

A clear pathway to market will increase efficiency and accessibility for these products in medical and prescribed home care settings, thus benefiting medical practice and the individual infants.  There are currently 10 approved HMFs. Many more are expected to be approved with the implementation of this programme.  

Safety of infants is of utmost priority. This framework lays out clear guidance for the regulation and oversight of safe and innovative products.  A risk-based approach will be taken to implement and enforce these products.

Quick Definitions:

Human milk fortifier means a food that: (a) includes at least one added vitamin, mineral nutrient or amino acid, and (b) is labelled or advertised as intended to be added to human milk to increase its nutritional value in order to meet the particular requirements of an infant in whom a physical or physiological condition exists as a result of a disease, disorder or abnormal physical state.

Infant means an individual who is under the age of one year.

New (Draft) Guidance Documents:

Health Canada is currently drafting 8 new guidance documents regarding HMFs. If you would like access to any specific draft guidance document such as: Guide on the Sale of Human Milk Fortifiers please reach out to our team. 

Premarket Submission:

HMFs were previously marketed under the Temporary Market Authorization Framework, like caffeinated energy drinks and supplemented foods. Now, HMFs are required to be submitted to the regulator and reviewed prior to sale on their own. Applications are to be submitted to allow sufficient time for review prior to April 30, 2022. Applications shall include the following components:

  • Brand name
  • Manufacturer’s name and address
  • Name and address of other manufacturing establishments
  • Quantitative list of ingredients
  • Formulation rationale
  • Product specifications, Including nutrients, microbiological and physical quality
  • QC details for product and ingredient testing
  • Details of manufacturing process and QC procedures
  • Stability results, to determine expiry
  • Nutritional adequacy support, when consumed under the proposed directions
  • Description of packaging
  • Directions for use
  • Copy of all labels to be used
  • Name and time of applicant who signed and dated the application

Authorization and Application Review:

Should the application be deemed complete and sufficient the product would be authorized. The regulator may also request changes or conditions prior to approval. Additional information or confirmations may be requested during the submission process. Resubmissions and new approval would be required if your formula undergoes a major change, unless otherwise authorized by the regulator. If any information submitted is missing, considered false, misleading, or deceptive the application may be refused.

Legal Sale:

HMFs will only be sold to hospitals directly or to individuals for home use with a written order (prescription) from an authorized physician, nurse practitioner, or dietitian (Health Care Practitioner). Industry will not be able to sell these products direct to consumer.  

Label Requirements:

Labels of HMFs are required to carry the following information on the outer label:

  • List by quantity the amount of protein, fat, carbs, and fibre (in grams)
  • Statement of energy value/calories 
  • Statement of quantity (in mg or mcg) of all vitamins, minerals, or amino acids
  • Statement of quantity (in mg or mcg) of any other nutritive substance
  • Storage instructions for both opened and unopened containers 
  • Directions of use including preparation and storage instructions
  • Statement to only use this product under medical supervision
  • Expiration date
  • Lot number
  • Any other statements or content required to be added during review. 

Information can be displayed on outer label, inner label, or on an affixed leaflet. 

You are not permitted to list the following on any labelling or any advertising materials to percent daily value amounts. 

Health Claims:

It is suggested to remove/limit all health claims regarding these products, as it would be the health care practitioner’s discretion when and why they are dispensing the product. Marketing verbiage and imagery should also be minimal.

Formulation:

Ingredients used in HMFs may include Amino acids, Minerals and Vitamins.

Item 6 of tablet in section D.03.002

Also, based on recent safety assessments, several new food additives will be permitted for use in Human Milk Fortifiers. These include carrageenan, gellan gum, lecithin, monoglycerides, potassium citrate, potassium hydroxide and sodium citrate. Please keep in mind each of these may have specifically approved purposes and required cautionary statements. Otherwise, Infant foods are currently prohibited from containing food additives, but some can be granted. There currently are no limits set for these ingredients for HMFs the responsibility will be on the applicant to prove each ingredient is safe and effective. 

Safe Foods for Canadians Regulations Note:

All foods in Canada will be regulated by the Safe Foods for Canadians Regulations. Conventional and supplemented foods now have additional requirements such as: Licensing, Traceability and Preventative Controls. Reach out to our team for assistance complying and importing within this new framework.

How Quality Smart Solutions can help:

At Quality Smart Solutions, we provide you with the guidance to plan your food business, navigate the legal requirements, and acquire the appropriate license for your operations. 

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including Hazard Analysis, SOPs, Preventative Control Plans (PCPs) and more.

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

30 Minutes Free Consultation

References:

Canada Gazette Part II Listing

List of Human Milk Fortifiers

List of Guidance Documents

Food and Drug Regulations

Categories
Blog

Conventional Foods vs. Supplemented Foods

Conventional Foods vs. Supplemented Foods

The easiest way to know the difference between these categories are that Conventional foods are older-common foods and Supplemented foods are newer-unique foods. 

The category of supplemented foods(canada.ca) originated from the struggle of classifying and regulating the first handful of novel Energy Drinks in Canada. Companies originally held NPNs (Natural Product Numbers) for their Energy Drink products, but the dosage format (ready-to-drink beverage) does not lend itself to dosing as is required for NHPs (Natural Health Product). Thus, a new category was born. 

Originally intended to be a short-term bridge for safety and market data collection, Temporary Market Authorization Letters (TMAL) were granted to supplemented foods. Years later, this is still the practice for obtaining regulatory approval for a Novel/Supplemented food. Since NHPs are closely related to these products, it is necessary to consider this as a third option when classifying foods and supplemented foods. 

Regulators want to ensure consumers are well educated and prepared to make decisions regarding nutrition and food selection. With safety in mind, ensuring all products are regulated, formulated, labelled, and classified properly can help protect the population from unwanted side effects. Additional regulatory requirements aim to ensure this added protection.

How These Categories Are Defined:

Food: It includes any article manufactured, sold, or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose.

Supplemented Food: A supplemented food is broadly defined as a pre-packaged product that is manufactured, sold, or represented as a food, which contains added vitamins, minerals, amino acids, herbal or bioactive ingredients. These ingredients may perform a physiological role beyond the provision of nutritive requirements. 

Other novel foods are: Products and ingredients that do not have a history of safe use as a food, Foods resulting from a process not previously used for food, causing the food to undergo a major change, or Foods that have been modified by genetic manipulation, also known as genetically modified foods, genetically engineered foods, or biotechnology-derived foods. Foods meeting this classification are submitted for premarket assessment and assigned a Temporary Market Authorization Letter (TMAL). 

Natural Health Product (NHP): It is a substance or combination of substances in which all the medicinal ingredients are manufactured, sold, or represented for use in: 

(a). the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans; 

(b). restoring or correcting organic functions in humans; or 

©. modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health. 

Products meeting this classification are submitted for premarket assessment and are assigned a Natural Product Number (NPN).

In summary, and in most cases, a supplemented food usually sits between the classification of Traditional food and Natural Health Product. Usually, these are a traditional food that has added ‘active’ ingredient(s) or attribute(s). This alteration/fortification would be considered novel. 

Classification Considerations:

Product Composition: Any fortification of ingredients or novel preparation as per the definition (of a supplemented food when a vitamin, mineral, amino acid, herbal or bioactive ingredient is added to a food), would shift the classification into territory of Supplemented Food. 

Product Representation: Any marketing verbiage, label claims, images, etc. suggested on traditional foods are very regulated and regimented. Wording for foods is intended to speak more to flavour, texture and satiety. Health claims by way of nutrient function can be available for use, so long that your ingredient/food meets any specific criteria. How you represent or speak about your product may shift the classification.

Product Format: is a key indicator for classifications on the Food vs. NHP interface. Ready to drink beverage and snack bar formats are commonly thought of and classified as foods. Foods are generally linked to the concept of ad libitum consumption. Tablet and capsule formats are thought of as NHPs. NHPs are thought to be delivered more by dose. 

Public Perception: of food plays a big role in classification. Questions you may ask yourself are: Have I eaten this before? Am I able to purchase this at the local grocer? Is there any historic or traditional use?  Has another country been eating this food for centuries? Etc. 

Since there are many overlapping-complicated concepts involved in classification of foods, supplemented foods and NHPs, we highly suggest a formula feasibility review for all supplemented foods. And, in some cases, we suggest reaching out and receiving written confirmation from the regulator. 

The Experts at Quality Smart Solutions can review your formulation to determine product classification.

Supplemented Foods Formulation:

It should be noted there are ingredients that are not permitted in supplemented foods. There are also specific ingredient limits set out for these types of products. Health Canada has posted several guidance documents that refer to specific types of supplemented foods (such as: caffeinated energy drinks). 

Labelling Differences:

Risk statements, directions of use and other labelling items are often required on the label for supplemented foods, depending on the amount of ingredients within the formula. This is explained in the applicable guidance document to which your product best fits or can be assigned by Health Canada during their review of the application. Similarly, both products will require a Nutrition Facts Panel and will follow general food labelling regulations.

The Experts at Quality Smart Solutions can conduct a review of labels or marketing materials for your food products.  

Simplification of Pathway to Market:

Conventional Food – Compliant/bilingual label, adhering to food specific requirements/standards, arranging importation and distribution, meeting SFCR requirements.

Supplemented Food – All of the above plus licensing requirement which entails: a TMAL Application (may include: a label, label text, application form and other administrative documents). During the review of your application, Health Canada will likely issue several rounds of Request Notices. Health Canada reserves the right to suggest/make changes to your formula, application form and label content to ensure your product is compliant. 

Natural Health ProductNPN (review timeline 60-210 days, depending on product class), Compliant/bilingual label, Manufacturing site annexed to a Canadian Site License. 

Post Licensing Requirements for TMALs:

To help Health Canada draft appropriate regulations for supplemented foods, there are additional requirements throughout the lifecycle of your product. This data/research protocol will be agreed upon with Health Canada during their review. Adverse events are also required to be recorded and submitted to the regulator annually. These pieces of data will help Health Canada understand consumer trends and provide support for any ingredients being used.

Safe Foods for Canadians Regulations Note:

All foods in Canada are regulated by the Safe Foods for Canadians Regulations (SFCR). Conventional and Supplemented foods now have additional requirements such as licensing, traceability and preventative controls. 

Reach out to our team for assistance complying and importing within this new framework.

How Quality Smart Solutions can help:

At Quality Smart Solutions, we provide you with the guidance to plan your food business, navigate the legal requirements, and acquire the appropriate license for your operations. 

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including Hazard Analysis, SOPs, Preventative Control Plans (PCPs) and more.

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

30 Minutes Free Consultation
Categories
News

Veterinary Health Products to be allowed in Livestock Feed

Health Canada and the Canadian Food Inspection Agency have joined forces to evaluate the incorporation of Veterinary Health Products (VHPs) into Livestock Feeds (Food).

This Project originated from an expressed interest by the industry to allow active VHP ingredients into Livestock feeds. Since the successful roll-out of the more recent VHP Notification Program, many Health Products have been approved for use. But more work is still needed to ensure these beneficial ingredients can be safely and legally added to foods for our animals. The marriage of these two product classifications may be on the horizon and your company can be part of the regulatory decision-making process!

Please note you can amend your SFC license at any time utilizing the My CFIA Portal without incurring an additional fee.

Obtaining a Safe Food for Canadians License:

The first step involved in obtaining a Safe Food for Canadians license is to create a My CFIA Account. It is through the use of the My CFIA account that you can request license and export certifications as well as set up electronic payment methods. While enrolling, you can create one or more profiles for your business. This way if your company involves multiple site locations, you can have a profile for each site.

Within the current framework, VHPs and Livestock Feeds are sorted into distinct categories requiring a separate regulatory pathway to market. Livestock feeds are currently regulated based on two published ingredient lists, requiring notification when for example, ingredients are listed in Part II of the regulations, when ingredients are considered novel or when other languages (besides English and French) are used on the label. VHP Notifications must be submitted for all products, a Notification Number is assigned upon approval.

Under this new investigative project, several common and low risk Organic Acids and Essential Oils are being explored. Industry will be able to make label claims for these ingredients relating to maintaining general health for approved products. Only these types of general health claims are allowed currently allowed for VHPs. [Veterinary Health Products: used to maintain or promote the health and wellness of companion and food-producing animals. VHPs are not for use to treat, prevent, or cure a disease or condition.] Products with more specific: therapeutic, antiparasitic or antimicrobial claims would better meet the classification of a Veterinary Drug and not be allowed within the scope of this Project.

This Project will help regulators gather important data for use in law/decision making and the future of both Veterinary Health Products and Livestock feeds. Ultimately, leading to improved access to Health Products and a wider range of ‘active’ ingredients for livestock. Thus, easing the path to market for VHPs, enabling broader aspects to these types of products and reducing the use of drugs and other antimicrobials for animals. A compendium of ingredients will be published at the conclusion of this program to allow newly approved ingredients to be used in Livestock Feeds.

For this specific project, industry has been provided with a List of Ingredients that will be permitted. This will allow Health Canada to control the project and gather specific evidence on ingredients they have deemed as potentially acceptable. Under the current proposal allowable ingredients may include:

  • Organic Acid, such as Acetic acid and Malic acid.
  • Essential Oils, such as Peppermint and Rosemary.
  • Common Non-medicinal ingredients such as Coconut oil and Silicon dioxide.

Each ingredient may have specific inclusion limits as explained within the Notice or the currently published Permitted Substances List. Please reach out to our team to determine the admissibility of your ingredients.

The following formula criteria must also be met to be eligible for the program:

  • Contain at least 1 approved active/medicinal ingredient.
  • Contain only approved inactive/non-medicinal ingredients.
  • Make only approved general health (VHP style) claims.

The company representative will need to attest that the product is safe and supported by convincing evidence and that the product is effective when used properly per the directions. Under this project, please ensure that all manufacturing processes are evaluated to ensure the final availability or stability is not impacted when any new ingredients are added to your food.

The recommended use of the product is to be marked specifically on the application and you will need to confirm the formula has been sufficiently tested. Products currently marketed as either Food or VHPs will need to be re-submitted to be eligible for this new project. When a VHP product or ingredient is being added to livestock feed, the new label will also be required to carry the VHP Notification number.

The sequence of steps for this proposal, as laid out in the notice are:

  1. Pre-screening Process (begins March 2021)
  2. Notification Process (begins May 2021)
  3. Publication of Compendium (July 2021)

To register, prescreening templates with product information must be submitted to Health Canada between March 15th and April 2nd, 2021. Once approved for eligibility by Health Canada a subsequent Notification will need to be sent.

Please contact our team for more information on Veterinary Health Products, Livestock Feeds or to have one of our specialists determine if your formulas are eligible and to enroll in this exciting project!

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

30 Minutes Free Consultation

References:

Health Canada and the Canadian Food Inspection Agency to launch a pilot project to allow veterinary health products in livestock feed, Inspection Canada

Veterinary Health Products – Notification Program, Government of Canada

Rules for VHPs, Government of Canada

Update on the pilot project to allow veterinary health products in livestock feed, Inspection Canada

Introduction – Regulation of Livestock Feed in Canada, Inspection Canada