This guide provides an outline to the packaging and labelling requirements for prepackaged non-food For information on the labelling of food products, contact the CFIA at 1‑‑‑ Misleading representations can come in many forms. . Please refer to subsections 5(1) and 5(3) of the Regulations for details. Product labels and the package leaflet play an essential part in the . combinations (fix-a-form labels), please refer to the IMB Newsletter Issue Number 33 for instructions on how to remove the tablets should be included. Until the guide is updated, please refer to the Nutrition Facts label call the appropriate telephone number listed on the title page of this guidance. Under FDA's laws and regulations, FDA does not pre-approve labels for food products. and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling.
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Cautions shown within quotation marks in the Regulations must be printed verbatim. If the caution or warning does not appear within quotation marks, the wording may be altered but the meaning must be retained.
Additional warnings and cautions outside the Regulations and specific to the drug product or drug product class may also be required on labels to help ensure safe use of the drug product. Except as otherwise provided in the Regulations , pursuant to section C. The standards of each individual ingredient should not be declared on the main panel of the label of a multi-ingredient drug product as it misleadingly implies a pharmaceutical standard for the combination.
However, when a standard exists for the entire combination, then this standard must normally Footnote 10 be declared on the main panel of the label. Except as otherwise provided in the Regulations , the method of declaring the quantities of active ingredients should be as described in the following table. The use of terminal trailing zeroes following a quantitative declaration of the medicinal ingredient should be avoided. Use 2 g rather than 2. When a quantitative amount is expressed as a decimal number less than 1, then the declaration should be preceded by a leading zero, such as 0.
For non-parenteral drug products that must be diluted prior to use e. When a drug product contains a single medicinal ingredient, a declaration of the quantity of medicinal ingredient immediately following or preceding the proper or common name of the drug product is acceptable, provided that the amount refers to the medicinal ingredient in the form mentioned in the name.
The declaration of the medicinal ingredient should reflect how the strength of the drug product is expressed. A combination drug product may contain an immediate release medicinal ingredient along with modified-release medicinal ingredient in the same pharmaceutical form e. In these instances, the dosage form should be clearly labelled to reflect the combination.
The inner and outer labels e. To ensure the proper identification of these drug patches, especially to inform healthcare personnel in cases of inadvertent contact with these discarded patches by children and pets, the patch itself should be labelled with the following minimum information:.
Labelling for implants e. A complete listing of all nonmedicinal ingredients on the label of a non-prescription drug product increases patient safety and better informs the consumer and healthcare professional in deciding the most appropriate drug product for each patient.
The non-medicinal or inactive ingredients should be clearly separated from the medicinal ingredients with a heading such as "nonmedicinal inactive ingredients". These nonmedicinal ingredients should be identified by the common or proper name. Nonmedicinal ingredients should be generally excluded from the drug product name.
Exceptions can be made with respect to flavour, colour, fragrance or non-therapeutic purposes provided this purpose is specified in the brand, or product name. A nonmedicinal ingredient which forms part of the brand name should be clearly identified with the cosmetic, non-therapeutic purpose within the brand name e.
A single DIN is assigned for drug products varying in flavour, colour, or fragrance, provided that all other product characteristics including: For details concerning flavours, fragrances, and variable formulations, refer to the new regulations regarding nonmedicinal ingredients see Appendix B. The use of colouring agents in drugs is restricted to those listed in section C. Only the names listed in the Regulations may be used section C.
Note that with regulatory changes discussed in section 3. Health Canada's policy Non-medicinal Ingredients Nomenclature outlines the accepted nomenclature used in naming the non-medicinal ingredients in drug product formulations.
The list is not all-inclusive and does not imply acceptability for use in the labelling of all drug products; therefore, it should be used as a guide only.
Net contents must be declared on the outer label as outlined in section C. In some cases, however, it may be desirable to have this information on the inner label also. For drug product lines containing ophthalmic or parenteral drug product formulations, and where two products differ only in the presence or absence of a preservative, the label should clearly identify the presence or absence of a preservative, either by reference in the brand name or directly and prominently on the label.
Health Canada will issue two separate DINs to emphasize the difference in drug product identity. Co-packaged products containing two different drug products, or a drug and a non-drug item e. The labelling of co-packaged drug products must include only those claims and indications that have been authorized for the individual drugs.
The labelling requirements for drug products generally apply to all container sizes. However, some containers are too small to show all the information required by the Act and Regulations.
Where the container of a drug is too small to accommodate an inner label that conforms to the requirements of these Regulations , the inner label requirements of these Regulations do not apply to the drug in that container if:. Drug products may be packaged in special containers that are too small to accommodate an inner label that conforms to the requirements of subsection C.
This inner label may contain further abbreviated labelling, provided there is an outer label that meets all regulatory requirements. These packages should contain the information listed in Subsections A and B below, and as outlined in the Health Canada policy document, Labelling of Special Containers. Consideration should be given to the colour of the text and the use of non-reflective or coloured foils that may enhance the legibility of the text for these special containers.
The above information should be presented in a way that ensures that the package information is maintained and can be read after units have been removed. This can be achieved by printing in a repetitive manner or by embossing on the edge of each card.
Labels for single-dose packs should include the same information as labels for multiple-dose packs See A , but if there is insufficient space, the expiry date may be omitted.
For drug products containing multi-ingredients e. If a brand name is not unique for a particular potency, it is acceptable to have the brand name and the DIN appear on the blister package label e. Although a DIN is not required on the labels of small containers described in this section 3.
Pursuant to section A. The labels on these products must draw attention to the security feature of the package.
For further information, refer to the Regulations , section G. Drug products packaged in a disposable metal container designed to release pressurized contents by the use of a manually operated valve must show the cautionary statements, hazard symbols, and signal words as outlined in sections A.
Drug products packaged in unpressurized containers operated by a manual pump spray device or any other containers that contain flammable ingredients should show a cautionary warning indicating flammable contents and appropriate directions for use e. Technical information should be presented in terminology that is easily understood by the consumer. The amount of information provided should not exceed that required to arrive at a proper conclusion.
Technical information is more likely to mislead or deceive the consumer in controversial areas where scientific opinions diverge. Technical or complicated language should not be used to purposely obscure, disguise, or exaggerate drug product benefits.
Product Monograph , there is an increase in technical information that has to be explained to consumers. A balance is required between exposure to sufficient information for safe, effective, and informed use of a medication versus too much information, which could overwhelm the consumer.
For some prescription drug products there is no accurate consumer language to describe some conditions; therefore, the original technical language must be maintained, while attempting to explain the condition in a way the consumer would understand.
Subsection 14 1 of the Act prohibits the distribution of any drug as a sample, which is considered to be a package of a drug provided at no cost. However, subsection 14 2 allows the "distribution, under prescribed conditions, of a sample to physicians, dentists, veterinary surgeons, or pharmacists. Package labels inner and outer for drug products authorized for sale in Canada may include additional regulatory information approved by other regulatory jurisdictions e.
Subsection 9 1 of the Act prohibits the representation of a drug "in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. Drug products, due to their potential risk, should be labelled in an informative manner. Labelling should clearly indicate that the product is a drug.
Sponsors should avoid describing the drug product, its purpose, or method of use in a way that implies it is another product type, such as a food or cosmetic. Misrepresentation of classification can create an erroneous impression regarding the character, merit, and safety of a preparation e. Consumers and patients may be concerned about the health implications of certain medicinal and non-medicinal ingredients in drug product formulations e.
When an ingredient has been removed from drug products in Canada because of safety concerns, it is acceptable to include a statement to the effect that a drug has been reformulated to omit that ingredient or that the drug product does not contain that ingredient. Such statements are considered acceptable for a limited time e. For example, phenylpropanolamine as a non-prescription oral decongestant has been removed from drug products in Canada because of safety concerns.
Because such statements are intended to reinforce consumer acceptance of drug products, such statements would be acceptable for preparations that previously contained the subject ingredient and that belong to that class of products in which the subject ingredient could be expected. Label statements such as "sugar-free" are acceptable only for those drug products that do not contain any of the chemical classes of sugar, including sugar alcohols.
If the label bears a "sugar free" claim or equivalent, and if a sweetening agent or agents are present, then the drug product label should include a phrase such as "sugar-free- sweetened with agent X or Agents X, Y, Z Health Canada suggests that drug product labels claiming one of the sugar alcohols specify the number of energy calories provided per dose.
Claims such as sweetener-free, artificial sweetener-free, and artificial sweetener X-free may be acceptable if true. However, claims for the absence of a particular artificial sweetener e. In these situations, the declared absence of one sweetener should be accompanied by the equally prominent declaration of the actual sweetener used.
Drug products without sodium chloride may be labelled as "salt-free," while those without sodium may be labelled as "no sodium. Some consumers wish to avoid some specific side effects that can occur with some non-prescription drug products, but not others within the same product class e. Statements regarding the absence of a side effect are permitted provided the following conditions are met:. Scientific evidence exists to support the statement, such that the incidence of a side effect is comparable to when a placebo is taken.
The evidence would consist of data from well-designed clinical trials, including sufficient sample sizes and adequate control groups, such that a significance level of 0.
The substantiating data should include results derived from measurable, objective parameters, where feasible.
If the incidence of a particular side effect exceeds that for the placebo, the statement regarding the absence of side effects should not be used. There is a widely held consumer perception that the significant side effect is associated with comparable drug products of that class. For example, drowsiness is a side effect perceived to be frequently associated with the use of non-prescription cough and cold products. A claim indicating the absence of this side effect for a drug product within this product class, would be acceptable provided all other conditions are met.
The claim regarding the absence of a side effect provides practical consumer information so that consumers can readily identify the side effect or benefit. Statements about the presence of significant adverse effects are accorded equal prominence in the labelling material to statements about the absence of side effect.
The colour, contrast, position, and spacing of the information should be considered when assessing the requirement for equal prominence. No undue emphasis on the statement about the absence of side effects is presented in labels or advertising. Health Canada recommends that prior approval be obtained concerning the use of these statements for all drug products.
If any of the scientific information changes then these claims should be removed. Comparisons of the incidence of side effects on labels between the drug product and placebo are often misleading and should be avoided.
Other side effects observed about as often on Ingredient X as on the sugar pill, included abdominal pain, nausea, flatulence, dizziness, back pain, and influenza-like symptoms. This text requires an ability to evaluate two different comparisons and assess their significance, which may be difficult for some consumers.
The message should be as simple and straightforward as possible, limited to the side effects that are reasonable to expect. More appropriate wording would be, "Frequent side effects were headache and diarrhea. For prescription products and those administered or obtained through a health professional, as of June 13, there are new regulatory requirements under C.
These requirements specify the need for an assessment as to whether there is a likelihood that the drug will be mistaken for any of the following products due to a resemblance between the brand name that is proposed to be used in respect of the drug and the brand name, common name or proper name of any of those products:. These similarities may pose a health risk by causing confusion in the prescribing, dispensing, administration of a drug product, or in the selection of a non-prescription drug product by the consumer.
For prescription products and those administered or obtained through a health professional, please refer to: The consumer, while competent to evaluate comparisons of taste, flavour, colour, and appearance, generally lacks the expertise and access to the supporting data required to evaluate the implications of comparisons about the therapeutic properties of drug products.
Some terms and phrases used to describe the composition of drug products imply comparisons that convey an erroneous impression regarding a product's value and merit. The terms "better," "richer," and "stronger" indicates an unidentified comparison which may be misleading and implies product superiority when this may not be the case.
Where a drug product has been reformulated to be significantly more effective or to provide an additional therapeutic advantage over a previous formulation, the use of "better" may be acceptable, if carefully explained.
However, it should be clearly indicated that the drug products being compared are the old and new formulations. To avoid violating subsection 9 1 of the Act , sponsors should describe such a product as a "new" or "improved" formulation. The use of such terms to describe novel or modified products is acceptable for one year. Therapeutic claims are those related only to the therapeutic aspects of the drug product e.
Directive and Guidance Document provides:. The purpose of Therapeutic Comparative Advertising: Directive and Guidance Document is to provide a framework for supporting evidence and presentation of comparative therapeutic claims in labelling and advertising, to ensure these claims are not false, misleading, or deceptive to the intended user.
Refer to the Health Canada's Guidance for Industry: The Therapeutic Products Directorate TPD is not responsible for the review of the comparative, non-therapeutic qualities claimed for drug products in labelling e. The purpose of the existing Health Canada policy, Principles for Claims Relating to Comparison of Non-therapeutic Aspects of Non-prescription Drug Products , is to define the conditions under which such comparisons will not be considered false, misleading, or deceptive as to the therapeutic character, value, quantity, composition, merit, or safety of the drug product to the intended audience.
This measure is to aid sponsors and the industry to create labelling and advertising in compliance with the Act and Regulations , particularly subsection 9 1 of the Act. The sponsor is responsible for ensuring that the applicable non-therapeutic, comparative claims meet the requirements of Health Canada's policy.
Health Canada does not accept complaints concerning overall impression of comparative, non-therapeutic claims unless these claims interfere with the therapeutic aspects of the drug product. Advertising complaints concerning these non-therapeutic comparative claims can be forwarded to the sponsor, the courts for complaints brought under the Competition Act or may be considered by industry or voluntary pre-clearance agencies.
The terms "high" and "low" generally imply unidentified comparisons and standards against which a drug product must be measured. For most product classes, these standards do not exist; therefore, these terms are unacceptable. To avoid misleading the consumer regarding the benefits of a product, more specific terminology should be used.
In some specific drug product areas, such as sunscreens, where a measurable standard of comparative performance is available e.
The following subsections provide guidance for the use of endorsements, testimonials, and quotations from the media or medical literature. Endorsements of drug products e. The endorsements should also be consistent with related Health Canada guidance documents and policies. Seals of approval on the labelling of certain drug products issued by independent professional bodies e. This recognition must be consistent with the terms of market authorization of the product.
TPD will conduct only one evaluation to validate the criteria used by the attesting organization. Product-specific data showing that a product meets this seal of approval is not expected with a drug product submission submitted for review but must be available on request.
Testimonials or quotations from individuals on drug product labels frequently constitute an unfair and biased advantage. There may be no acceptable way of indicating on the labelling how such cases compare with the frequency of failure or success of that treatment. It may be misleading to build unwarranted expectations in the consumer's mind by the use of success stories. However, if such testimonials are consistent with the expected benefits of the product and the terms of market authorization, they can be accepted following critical review, provided the testimonial does not otherwise violate the Act and Regulations.
Quotations from scientific journals, papers, authoritative texts, magazines, newspapers, or any other media source may create an erroneous impression regarding the character, value, merit, or safety of a drug product. This material may not reflect the entire data package supporting the drug product and may represent the isolated opinion of the author or a biased selection of data; therefore, sponsors should avoid using quotations on drug labels.
Cosmetic claims and any description of the cosmetic or non-therapeutic attributes of the drug product fragrance, texture, colour are acceptable for therapeutic products provided they:. Any cosmetic claim attributed to a specific ingredient e. The term "cooling" may be used in a therapeutic sense, if the drug product contains a medicinal ingredient for a therapeutic purpose such as "for cooling relief of sunburn" e.
The term may also be used in a non-therapeutic sense if adequately explained e. The following subsections describe positive promotional terms that may be used under certain conditions on drug product labels. Although Health Canada does not review these label claims, where advertising disputes arise there are self-regulatory industry bodies that may deal with complaint resolution.
The terms "clinically proven"or "clinically tested" can be used on drug product labelling provided:. An example would be dextromethorphan syrup in product X: An example would be Product Y containing dextromethorphan and other ingredients that are not in any Health Canada labelling standard or monograph for pharmaceutical drugs, or in Category I, United States Federal Register.
The statement "Dextromethorphan provides a clinically proven cough relief" would be acceptable, whereas, the statement "Product Y is clinically proven" would not be acceptable. Another example would be a combination drug product containing only dextromethorphan and pseudoephedrine hydrochloride, the benefits of both of which are documented in the literature: The following statement would not be acceptable: The word "new" may be used to describe a drug product that is marketed under its present brand name for the first time in Canada, or in a different version of an existing preparation e.
The use of the term "new" for more than one year of product sale is considered to be misleading. For a drug product that has been modified in a manner that provides a significant therapeutic advantage over a previously marketed product of the same name e. This type of claim requires prior review and approval as part of the market authorization for the product.
In cases where the improvement refers to some non-therapeutic aspect of the formulation e. See also Section 4. There are only a few drug products that can be considered "advanced" and labelled as such to the general public. Most drug products are part of a product class with similar product attributes, where it is difficult to identify any particular drug product as "advanced," compared to another in its class. To be considered "advanced," a drug product would require some new or added therapeutic benefit, which is clinically significant, meaningful, and easily identified by the consumer, compared to others in its therapeutic class.
The term "advanced" in a drug product name is acceptable in a therapeutic sense if the advanced product treats a wider range of symptoms or has an additional medicinal ingredient compared to a reference drug product in the same product line. Consistent with the extra strength policy Section 4.
In some cases, qualified claims concerning advanced non-therapeutic aspects e. The use of terms such as "strong" or "extra strength" may be erroneous. Drug products are formulated to provide an amount of medicinal ingredient in an effective therapeutic range.
Use of this wording may imply that the drug product is therapeutically more effective, when in most cases there is no data to support a difference in product effectiveness within an acceptable dosage range and population. The use of terms such as "regular strength" and "extra strength" are acceptable to describe drug products within a product line where various quantitative amounts of medicinal ingredient are provided.
In most cases, the term "extra strength" can be used only if there is a regular strength reference product on the market containing the same medicinal ingredients. However, exceptions to this general interpretation are described in the following two subsections. Since dosage units for some analgesics are standardized by regulation, the use of the term "extra strength" to describe higher strength per dosage unit products is permitted.
Health Canada considers that the term "extra strength" as useful information to the purchaser during product selection. As noted in Section 4. The extra strength ingredient should be identified in the list of medicinal ingredients as follows:. Drug products with undefined standard strengths will be evaluated on a case-by-case basis with data submitted to support the extra strength claim.
The following lists of ingredients are in products that have defined standard strengths. Reference to a therapeutic action as "complete" or "total" e. However, the words "complete" or "total" have been accepted in the brand names of drug products to indicate that they treat several symptoms of a temporary condition e.
Consistent with the use of "extra strength" Section 4. The naming of drug products in a product line extension should not create name confusion with respect to other products in the line.
The use of the term "plus" in the brand name or as a label descriptor is acceptable in a drug product line that contains a reference product and where the "plus" product contains an additional amount of one or more ingredients or an added medicinal ingredient that provides an additional therapeutic benefit.
The term "plus" is also acceptable in the brand name of a product when an additional non-medicinal ingredient has been added to the formulation and is clearly identified on the label e. The following subsections describe potentially misleading promotional terms that should not be used on drug product labels unless specific data, rationale or circumstances support such a claim, or the addition of appropriate qualifying statements justify the wording.
Descriptive wording and phrases to describe the activity, effects, attributes, formulation, or development of drug products should be chosen to ensure that the consumer can appreciate the actual situation. Any undue emphasis, highlighting, or unbalanced presentation of one ingredient, attribute, claim, or feature of a multi-ingredient drug product at the expense of the other ingredients and attributes may be misleading as to the merit of the product.
Examples may include highlighting:. Labels should represent the drug product identity and benefits equally and completely. There is no objection to adding inclusive statements on the main panel of the label e.
Highlighting a non-medicinal ingredient is also acceptable if the non-therapeutic purpose is clearly identified e. The term "maximum strength" may be misleading with respect to the composition and therapeutic merit of a drug product and is considered to be unacceptable in most cases. The term must be examined in the total context of the labelling. This term is considered to be indefinable for most drug products and understood to mean the single or total daily dosage or both.
Although regulatory limits may exist for the availability of certain non-prescription drugs e. New scientific evidence may increase or decrease acceptable dosages depending on circumstances, and each drug product is evaluated on its own merits and the specific conditions indicated. The concept of absolute maximum limits for a drug product is difficult to maintain due to the variation of patient circumstance, product use, and the constantly changing scientific environment.
Moreover, the term "maximum strength" may create an erroneous impression of a greater or maximum therapeutic benefit to the consumer. This may encourage the consumer to believe that only a higher dose of medication can provide adequate relief of the symptoms, when often the regular strength product will provide sufficient relief.
More accurate terms are preferred when describing a drug product in a product line containing various concentrations of an ingredient. Where federal regulatory limits for non-prescription drug product availability exist, qualified statements accompanying the term maximum strength e.
The overall context of the use of such qualified statements would be evaluated on a case-by-case basis. In addition to federal regulatory limits on the strength of some non-prescription drug products the provinces and territories may have further regulatory limits on the distribution of some drug products in their jurisdiction that may vary for each province and territory.
Drug product labels using descriptors such as "concentrated," "potent," or "strong" are often erroneous because drug products are formulated to provide an amount of medicinal ingredient within an effective therapeutic range. The use of such wording may imply that the drug product is therapeutically more effective when in most cases the data is not available to support a difference in effectiveness within a given acceptable dosage range and within a population. However, there are situations where label descriptors such as "concentrate," "concentrated," or "highly concentrated," in conjunction with other directions e.
The term "unique" is generally not considered acceptable on the labelling of drug products unless it refers to products that possess a unique therapeutic action or formulation of medicinal ingredients. There are a limited number of drug products that could be considered unique or exclusive in terms of action, effect, or formulation, particularly in classes of drugs where actions and attributes are quite similar.
The use of this term without qualifying it is generally considered misleading and unacceptable. As no drug product is completely safe and without potential for adverse effects, the unqualified term "safe" is considered to be generally misleading and unacceptable for drug product labels.
However, in the context of providing adequate directions for use, the word "safe" may be part of the directions e. While drug products are intended to treat unhealthy conditions or to assist in maintaining good health, general unqualified descriptions of a drug product such as restoring general health or promoting healthful conditions are false. The term "natural" to describe a drug product may imply some special benefit or added safety to consumers, which could be misleading as to the merit of the product.
A drug product may be described as "natural" only when it is sold in its original state without processing or refinement by humans. Where the original state of an ingredient is altered or changed, the use of the term "natural" in describing such a drug product would be false, misleading, or deceptive, and likely to create an erroneous impression regarding the character, composition, merit, or safety of the drug.
This would be in violation of subsection 9 1 of the Act. Very few drug products are so devoid of processing to justify the description "natural. Drug products of animal or vegetable origin and handled with minimal processing to retain most of the original constituents, may be described as "natural source.
Because all drug products act by artificially stimulating or modifying the chemical functions of the body, the description of the pharmacological effect of a drug product as "natural" or "natural action" is false and not acceptable in drug product labelling.
The unqualified term "antioxidant," when used in labelling, is considered to imply some vague therapeutic benefit of the drug product that is usually misleading, generally unsupported by the lack of available data, and should not be used. This reference may be acceptable in terms of Good Manufacturing Practices, if it is clearly explained.
Subsection 14 1 of the Act prohibits the distribution of any drug as a sample. Subsection 14 2 allows sampling to certain healthcare professionals and further Regulations apply to this activity. Although the Act and Regulations do not define a "sample. It is generally inappropriate to label any non-prescription drug product as "free. Co-packaged products should be appropriately labelled, as outlined in Section 3.
False representation is a presentation that contradicts current medical or scientific knowledge and is unsupported by clinically valid and statistically reliable data conforming to current standards. Such presentations may be considered in violation of section 9 1 of the Act.
Due to the constant evolution of medical and scientific knowledge, claims that were once acceptable for a drug product may become invalid over time. Such claims include the use of outmoded therapeutic concepts e.
These claims may be significant in the labelling of older drug products that have not been recently updated. The terms "fortified" and "enriched" are difficult to employ without creating an erroneous impression. In most cases this formulation change is limited to either the addition of an ingredient to a formulation or to an increase in concentration of an ingredient.
Both these changes do not justify the use of the terms, where there is no proven therapeutic benefit for them. These terms may imply that the drug product is therapeutically better because it contains more of a certain ingredient, whereas the formulation remains within an effective therapeutic range to accomplish the same effect and data is not available to show any differentiation in effect based on different strengths.
Drugs should be promoted in a positive fashion to provide the consumer with useful information. Negative statements may be derogatory, implying that another drug has a negative effect. A negative statement of this kind is considered to be misleading because it requires an interpretation of the implications of the statement by the consumer. Negations such as "non-toxic," "non-poisonous," or "non-allergenic" create an erroneous impression regarding the safety of a drug product.
No drug is completely harmless, especially if abused or misused. Only those preparations sold under section 36 of the Narcotic Control Regulations are available to the general public without a prescription because their potential for abuse or misuse is limited.
The term "non-narcotic" on a drug product label may negatively imply that other drugs in the same class are narcotizing, or have a potential for abuse, when this may not be the case. This is a misleading representation and is not acceptable. Therefore, informative or qualifying statements regarding these ingredients may be acceptable. For additional information see Section 4. Label text should not exaggerate the condition the drug product is meant to treat in such a way that will induce fear in the possible consequences of not treating the condition.
It is not appropriate to suggest that the health of a consumer will suffer or that full health cannot be obtained unless a particular drug product is used.
Most non-prescription products treat symptoms of self-limiting conditions, not the condition itself. Most conditions resolve on their own, with or without the use of medication. It is also inappropriate to create fear of social embarrassment that may result from the consequences of a condition that may occur without the use of the medication e.
Therefore, terms such as "dangerous," "violent," "harsh," "hazardous," and "acute" are generally unacceptable when describing symptoms. A balance between fully informing the patient, and avoiding any unnecessary fear-inducing copy should be maintained for these products. Few conditions suitable for self-diagnosis and self-treatment in the non-prescription area would be considered acute, severe, chronic, or dangerous.
In situations of a chronic or severe nature, the care and attention of a doctor or other healthcare professional is usually required. The use of these terms is generally considered misleading and unacceptable for non-prescription drug products. Similarly, such terms may not be appropriate in the consumer labelling of prescription drugs, if considered to be unduly alarming or an exaggeration of the medical condition.
Using the word "need" in labelling statements e. This term is inappropriate for most non-prescription drugs used to treat the symptoms and discomfort of self-limiting conditions that resolve on their own. Exceptions to this general statement for non-prescription drugs include vaginal antifungal preparations. For prescription drug products, a doctor may decide a patient needs a particular drug product to treat a serious condition and wording in this context may be appropriate in the consumer information section of a prescription drug monograph e.
The use of the term "tamper resistant" to describe the security feature of a drug product package should be avoided, as this language may tend to encourage or incite tampering behaviour in some individuals. More neutral language should be chosen to draw attention to the security feature e. Cross-promotion of drug products with another drug, natural health product, medical device e.
Using pictures, charts, graphs, statistics, and symbols in labelling can often be misleading as to the use, merit, and character of a drug product and should be avoided.
Often these additions to labelling may imply some therapeutic benefit that is unauthorized for that drug product e. All graphics that are considered to be therapeutically content-related, directly or indirectly implying any therapeutic attribute must be shown on the draft label included in the original drug submission see Section 2.
Prescription products and those administered or obtained through a health professional have new requirements to file mock-ups of labels at the time of submission as of June 13, These mock-ups are not draft labels but should reflect the final label which, once approved, will be used to market these products. For new drugs in the old PM format where there is Information for the Consumer i.
Information for the Patient section, the same label information as above is expected. For those in category a consumer-available non-prescription drugs where there is no requirement for professional intervention, the wording of the product labelling is especially important to ensure safe and effective use. Special labelling considerations are outlined below in the following section for these products. These standards and monographs provide basic information on: These standards and monographs should be consulted in conjunction with the Act and Regulations , and all other applicable Health Canada guidance and policy documents.
Consumer-available non-prescription drugs products, intended for self-treatment by the general public, must carry sufficient information on the labels for an individual to use the medication properly without consulting a healthcare professional. Furthermore, the terminology used should be explicit and easy to interpret. In some cases, a pharmacological classification could suffice as an indication for use.
However, such terminology has little meaning to the general public and specific indications are usually necessary. For example, the pharmacological classification of a drug product as an anti-emetic would be insufficient on a consumer-available non-prescription drug label; therefore, an additional indication such as "motion sickness" would be necessary.
Some indications for use may be evident in the trade name of the drug product, e. In contrast, "Brand Y Cough Syrup" would require further clarification indicating that it is an expectorant. The dosage on consumer-available non-prescription drug product labels should state the number of tablets or capsules per dose, or the volume of product to be delivered e. Separate directions for adults and children should be provided and if the product is not recommended for children, the dosage should be clearly identified as "adult dose.
Labels should generally state the route of drug administration. Labels for tablets, capsules, and some liquids intended for oral administration may not require a separate statement, as the route of administration is often obvious. If the route of administration differs from the usual route associated with a pharmaceutical form, the label should specify the actual route e. Frequently, a specific warning or precaution statement will be required for an individual drug product or product category.
The warning may not, in itself, be a regulated statement, but it is considered an expression of adequate directions for use based on medical or pharmacological reasons. A particular subset of narcotic drug products can be supplied to consumers without a prescription as defined in section 36 of the Narcotic Control Regulations , which states:. Such drug products are usually pain medications containing combinations of ingredients such as acetaminophen or acetylsalicylic acid, caffeine, muscle relaxants, and codeine.
The general labelling requirements as described in Sections 2 and 3 of this guidance apply to prescribed and parenteral drug products, except as otherwise noted in this section. The language in the labelling of these drug products is usually written for healthcare professionals; however, the labelling should have sufficient information to promote safe and proper use of a drug product and well understood by all users. Unlike the labelling conventions for consumer-available non-prescription drug preparations, the dosage directions for prescription and parenteral preparations may often be expressed in terms of units of weight of drug per unit of body weight e.
Although the pharmacological classification may replace specific indications on the drug labels, in cases where indications are specified, the dosage directions applicable to each indication or a dosage range encompassing all the indications should appear where possible.
However, for complex prescription drug products with numerous indications and various dosage regimens e. In these cases, the prescription drug labelling may be abbreviated provided that there is direction to refer to the package insert or product monograph e.
Both these documents are intended for use by a healthcare professional. A package insert is not required to be included with these drug products. In addition to the general labelling requirements outlined in Sections 2 and 3, there is specific information that applies to parenteral drug products.
For other injectable drug products such as powdered or special products e. The potency of medicinal ingredients may be declared in terms of the total compound or the active moiety, provided that the whole compound is identified by name. The dosage recommendations should follow the chosen method of potency declaration. For a drug product available in different potencies, the method of declaration should be identical for all potencies.
For further optional information on the labelling of parenteral preparations refer to Appendix C. The United States Pharmacopoeia requires that the labelling of parenteral preparations list the names and quantities of all ingredients except ingredients added to adjust the pH or to make a solution isotonic, which may be declared by name with a statement of their effect.
For drug products that are not declaring the USP standard, sponsors should provide the qualitative declarations of the complete formulation of parenteral preparations in all cases. This information is useful in promoting safe and proper use of these drug products. For the purposes of section C.
In addition to the regulatory requirements for the labelling of injectable products which includes the declaration of preservatives, labelling should also state the following information:. In addition, special labelling may be required to show the total osmolar concentration of the final formulation. The following table show several examples.
In addition, the caloric content provided per unit volume should be declared e. Pharmacy bulk vials are large volume vials containing multiple doses and are intended for a pharmacy admixture program to create infusion mixtures or transfer to empty sterile syringes.
These vials are not meant for direct injection. The closure to each vial is meant to be penetrated one time only with a sterile transfer device.
In accordance with Federal Legislation, there are some unscheduled non-prescription drug products that do not require a prescription as a condition of sale but are generally prescribed by a medical practitioner. These drug products can be easily accessible by consumers for certain medical conditions or for emergency use e.
Pursuant to provincial or territorial regulations, these drugs are kept behind the counter in pharmacies and must be distributed by a pharmacy healthcare professional e. They should not be advertised, labelled, or recommended to the general public for self-medication e. Schedule A diseases should not be included in the labelling of drug products that are available to the general public, unless the information is required for warnings and precautions or they have been authorized as preventative claims for some non-presciption drugs see Section 2.
In cases where a product is intended for a Schedule A disease and there is no appropriate pharmacological classification or indication other than the one that would refer to such disease, no pharmacological classification or indication should appear on the label section 3 2 of the Act.
Prescribing information that includes the indication must therefore be made available for physicians and pharmacists, and the label should state the availability of this document.
The label should also include a statement indicating that the drug product is to be used only on a physician's advice. Many of the drug products in the categories covered by this section which are not new drugs require that the directions for use be detailed in a document called "prescribing information" see Section 5. However, there are some drugs e. As of June 13, , there are new regulatory requirements for prescription products and those administered or obtained through a health professional.
These products are required to include contact information on their labels to report harms see section 2. While the regulations are not retroactive in application, sponsors are expected to bring their labels into compliance with the new regulations at the first submission after June 13, which requires a label change.
Drug products that contain salts for oral use e. In addition, the quantity should also be expressed in milliequivalents per unit of final volume for each element ion. The prescribing information i. Alternatively, it is recommended that the new format as outlined for Part I of the Guidance for Industry: Product Monograph is followed where possible. Special labelling is required to clearly identify and highlight these products and the tentative nature of their approval. A further category of federally unscheduled i.
These products are available to and intended for use by a healthcare professional and are distributed to hospitals, clinics or directly to physicians, dentists, and other healthcare professionals. To distinguish these products from similar consumer-available non-prescription drug products e. Adequate Directions for Use: A drug product that has been processed to the point where it is now in form which may be administered in individual doses.
Drug in Dosage Form: A full colour, actual size copy of the labels and a colour representation i. This includes drugs that. But we have done this with some of our case study products and had no issues, and many other sellers do too. For example, we ran a giveaway for a product to collect emails and put the giveaway URL on the insert.
So I think you would be fine to do what you are suggesting. Hi there, I have heard from some sources that it is allowed to include a registration card inside the FBA product package; the card will offer a free ebook or something if the customer goes to my website and signs up. Is it allowed to give my website in a registration card like this? One more thing to note, whilst you should never put a link in a follow-up email to a customer, you could also send ebooks as an attachment using a service like Jump Send.
Hey Kim, I believe I found my answer to my follow up question re: I think as long as a customer can see it somewhere, it is OK to go anywhere. Can I put this on the label with the UPC code? Also, I want to confirm, I put my web address on the insert.
The made in China label needs to go on the packaging itself I believe. In some circumstances you may need to put it on the label on the product for example I think textiles have different rules. Great to hear from you! I am learning so much from you and your million dollar learning experience! Do I need both? I was only planning on doing an insert — no label.
Inserts are usually for specific marketing messages i. Just make sure you do your research before deciding to ensure you are not required to also add a label to the product itself. It can vary by product type and which marketplace you sell in. I found this page, https: My product is packaged in a clear box, so I figured just an insert with the product name would be fine. I should have printed this on the insert but it is too late.
You are right it is a little confusing. In the case of product inserts, if you are the brand owner of your product, then there is usually a little leeway that you can leverage. The main thing is that Amazon do not want to see evidence of you diverting customers away from the Amazon shopping platform. We use a website for our Jungle Snugs case study product insert without any issues. The website is not ecommerce and only has information about the product.
I believe contact information for customer support is also OK to put in your inserts and packaging. If you imagine buying some Sony headphones, their packaging and product inserts will absolutely have information such as a website, warranty information and so on. Encouraging the customer to go to your website, and leave a review on amazon, is against the Terms of Service.
We did a post covering this earlier this year: I designed a sticker to go on the removable safety seal for the product, that 1. Thanks them for leaving a review, so othere can fin us. Tells them we have information and contests on our Facebook page no page url given.
Would this violate Amazon TOS? Hello to you Thanks for the great content. I have a question about the product packaging: You can order your packaging from a third party supplier, however your product supplier likely deals with a variety of packaging for your product, so that may be easiest.
So get the template from the supplier and send it off to a package designer. On the insert card example it seems clear that you are intending to direct all positive reviews to the product page. Also send all potential negative reviews to contact you. My understanding is that this would now violate amazon terms.
Only incentivized reviews are banned, that means offering free product or a discount and requiring a review in return. You are still able to ask paying customers to leave a review if they liked the product, but you should never incentivize this.
My current product presentation leaves much to be desired. It is just the product, a poly bag and the UPC label slapped on it. I want the experience of receiving and opening my package to be different than what it currently is. I want to differentiate my self and build a brand, not only sell a product. So what I want to understand is, once I designed my package through someone like Erick and Virtuous Graphics, how do I get the package itself done?
Who do I contact? And how do I get it to my product manufacturer so he packages my products using this new package design? I would like to understand the logistics behind it all so I can know how to best approach this. Great news that you are thinking of adding value to your product with improved packaging. Are you going to add any inserts? The most straight forward route is to ask your manufacturer to package your product using these new designs.
If this is how you want to proceed, it may be worth checking their capabilities before you commission any design work. Another option is to have the products packaged in the country of sale once you have imported them. Many sourcing companies offer this service, or you can use a packing and prepping service.
The main benefits to this option are that your supply chain is harder to follow can help prevent getting hijacked , and you can probably get higher quality packaging. But obviously this adds a step into your logistics and will also come at a cost. Thank you so much, Kym. No inserts yet for my next batch, although I changed the package a bit and got my brand logo on the package this time, but I might include some inserts for my next order.
Thank you for letting me know and for providing the details and different options, I have been going nuts over this for the past few days especially after reading this article lol. I am just getting started with my FBA business. I have chosen a product and now need to find packaging and a manufacturer. Do the manufacturers do the packaging there? If I need to find someone separate to do the packaging, does anyone have any suggestions as to who to contact?
Also, I have a company name, but do I need to create unique packaging for each product that is related to the product itself and possibly put the company name in smaller print somewhere on the label? Are you allowed to use the inserts and alter the packaging still or is it not allowed to advertise your own website since Amazon is doing the logistics process?
You can present your product packaging and inserts any way you like. For example, imagine if you bought a Sony TV on Amazon, it would still come with a warranty card and the Sony website on the packaging or inserts. If anyone has any questions related to product photography, product packaging; or would just like a free 20min consultation for me to look over on one of their listings. Your email address will not be published. Product with poly bag packaging and suffocation warnings. Hello, I need to know is sending gifts along with the product without asking customer to review the product in exchange of the gift violating amazon TOS?
Hadi, Yes it is, unfortunately. Thanks you any insight on this! That should be fine as far as I know. The big guys do it, too!
Is this product insert example still within tos? The second insert is asking for positive reviews only. I believe that is against TOS. Hello, still confused is it allowed to ask for a review on the insert or not? How it should sound to be allowed by amazon?
Simply log into your account to leave a feedback. Our team appreciate for your time. Thank you for the answer. This is a really interesting article. Hey Dmitri, You need to send in your products exactly packaged how you would like them to be sent to your customer. Hey Kev, You are right it is a bit of a grey area.
Hey Risa, The made in China label needs to go on the packaging itself I believe. Hey Kym, Great to hear from you! You listed two parts of packaging: Thank you SO much! Hey Joe, You are right it is a little confusing. Hi Justin, Encouraging the customer to go to your website, and leave a review on amazon, is against the Terms of Service. Thanks for sharing it………….: Hi Erez, You can order your packaging from a third party supplier, however your product supplier likely deals with a variety of packaging for your product, so that may be easiest.
Information on how to ship and package products being returned. your packing slip and label. They will be provided to you after you enter your RMA number. Please refer to the table below and return the checked product parts for the NAS product you are returning. Put the NAS Quick Start Guides/Software/CDs, X. Packaging inserts (also referred to as packing inserts) are usually unexpected and deal offers to be included with your packaging is to print them at business card size Second, product samples provide a great way to cross-sell be sent to their email, which engages user on yet another digital platform. Get some best practice advice on amazon product packaging and product inserts . Also, the seller included it in the main photo. Which, might I mention will also increase the valuation of your business should you ever phrase “Good things await you” with the inside flap showing the product instructions.