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Dietary Supplements Policy

If you supply dietary supplements for sale on Shoplazza, you need to comply with the laws and regulations that apply to your business. These laws and regulations depend on the region where your store is located and the region where you sell.

You're responsible for reviewing and using this information appropriately. This content doesn't contain and isn't meant to provide legal advice. This content is not all-inclusive and may be out-of-date. We encourage you to consult your legal counsel for any concerns about the laws and regulations relating to your product.

If you violate a law in any jurisdiction where you conduct business, Shoplazza may remove products or terminate your online store.

United States (US) Laws and regulations for selling dietary supplements:

If you sell dietary supplements to customers in the United States, then you're required to follow the Food and Drug Administration (FDA) regulates the manufacturing, packaging, storing, and labeling of dietary supplements under the Federal Food, Drug, and Cosmetic Act (FD&C Act)  , and its subsequent amending statutes, including the Dietary Supplement Health and Education Act (DSHEA)  .

According to 21 CFR 111.1  , you are subject to the DS CGMP rule in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement.

According to the FDA, dietary supplements are defined as a vitamin, mineral, herb, botanical, amino acid, or dietary substance that is intended to supplement the diet by enhancing overall dietary intake. It can also refer to a concentrated form, metabolite, component, extract, or combination of these substances.

Dietary supplements are available in various formats, including powders, pills, liquid drops, and oral sprays. The main categories are as follows vitamins and minerals, herbal remedies, products for sexual enhancement, aids for weight management, and nutritional supplements for bodybuilding and sports performance.

Dietary supplement categories may have differing compliance requirements. It is your responsibility to ensure that your product is compliant with the correct requirements.

* Please note that dietary supplements may not claim to treat diseases, contain undeclared drug ingredients, or claim to be approved as new drugs.

Packaging

1. Supplements must be sealed in the original manufacturer’s packaging

2. Supplements must be new and unused

3. Supplements must clearly display the identifying codes placed on the packaging by the manufacturer or distributor, such as matrix codes, lot numbers, or serial numbers

Labeling

1. Supplements must be labeled in English with the following information:

  • The name of dietary supplement（In the case of dietary supplements, both the Federal Food, Drug, and Cosmetic Act and FDA’s regulations specify that the statement of identity must include the term “dietary supplement,” except that the word “dietary” may be replaced with a description of the type of dietary ingredient(s) in the product （e.g., “herbal supplement”）or the names of one or more dietary ingredients in the product （e.g., “bee pollen supplement”).
  • The total quantity or amount of the dietary supplement, such as 50 tablets, 5 mg, 5 oz
  • The nutrition labeling
  • The ingredient list
  • The name and address of the manufacturer, packer, or distributor

2. Supplement labels must not contain disease claims or implied disease claims, unless the statement has been approved by the FDA. Disease claims include claims to diagnose, state that the products cure, mitigate, treat, or prevent a disease in humans. The FDA has provided criteria to assist entities in evaluating dietary supplement claims in their Small Entity Compliance Guide on Structure/Function Claims  . Disease claims require prior approval by FDA and may only be made by approved drug products.

3. Supplement labels must not claim that the products have the same effects as controlled substances or prescription drugs, such as names that could be confused with controlled substances or prescription drugs)

4. Supplement labels must not claim that the supplements are “FDA approved”

5. Supplement labels must not use the “FDA logo”

6. Supplement labels must not state “tester,” “not for retail sale,” or “not intended for resale”

Detail page

1. Detail pages must include the following information:

  • The name of the dietary supplement
  • The ingredient list, including an image of the ingredient list from the product label
  • The total quantity or amount of the dietary supplement, such as 50 tablets, 5 mg, 5 oz
  • A direct image clearly showing the entire product label, including applicable facts panel, ingredients list, certification logos, identity statement, instructions for use, any product warnings. Must also include the product name, and the name and contact information of the brand owner or manufacturer.

2. Detail pages must not state that the products cure, mitigate, treat, or prevent a disease in humans, unless that statement is approved by the FDA.

3. Detail pages must not include disease names in the keywords

4. Detail pages must not state that the products have the same effects as controlled substances or prescription drugs. Supplements cannot state that they are alternatives to prescription drugs or that they are just as effective as a prescription drug

5. Detail pages must not state that the supplements are “FDA approved”

6. Images associated with detail pages must not include the “FDA logo”

Products and ingredients

1. Supplements must not be named in an FDA recall or safety alert. For more information, go to Recalls, Market Withdrawals, & Safety Alerts  .

2. Supplements must not contain ingredients prohibited by the FDA (such as, contaminants or pharmaceutical drugs). For more information, please refer to Dietary Supplement Products & Ingredients  .

3. Supplements must not be adulterated, such as being unsafe or lacking evidence of safety, or misbranded like having false or misleading information on the label in an FDA warning letter. For more information, please refer to FDA Warning Letters  .

4. Supplements must be safe for use and must not be a product that the FDA has determined presents an unreasonable risk of injury or illness. For more information, please refer to Select Dietary Supplement Ingredients and Other Substances  

5. Supplements must not be named by the Federal Trade Commission (FTC) as making untrue marketing claims. For more information, go to Federal Trade Commission Press Releases  .

6. Supplements must not contain controlled substances, such as:

7. Prohibition of the sale of supplements containing some endangered animal ingredients:

For more information, visit the U.S. Food and Drug Administration's resources:

Additional Useful Resources

Canada Laws and regulations for selling dietary supplements:

If you sell dietary supplements in Canada, then you must also follow the Food and Drugs Act  , Food and Drug Regulations  , Natural Health Products Regulations  , In addition, there are relevant guidance documents, Guidelines for Consumer Advertising of Marketed Health Products  , Good Manufacturing Practice Guidelines  , Labeling Guidance Document  , and Natural Health Products Compliance and Enforcement Policy  .

Under the Natural Health Products Regulations  , Natural health products (NHPs) are naturally occurring substances that are used to restore or maintain good health. They are often made from plants, but can also be made from animals, microorganisms and marine sources. They come in a wide variety of forms like tablets, capsules, tinctures, solutions, creams, ointments and drops.

Natural health products, often called "complementary" or "alternative" medicines, include:

  • vitamins and minerals
  • herbal remedies
  • homeopathic medicines
  • traditional medicines like traditional Chinese and Ayurvedic (East Indian) medicines
  • probiotics
  • Other products like amino acids and essential fatty acids

Many everyday consumer products, like certain toothpastes, antiperspirants, shampoos, facial products and mouthwashes are also classified as natural health products in Canada.

Product license

Canada implements an approval system for natural health products, requiring a product license   known as the 8-digit Natural Products Number (NPN) issued by Health Canada for production and sales. Products manufactured in third countries require an import license and must demonstrate full compliance with Canada's Good Manufacturing Practices (GMP) requirements for products manufactured in those countries.

For information regarding the application for a product license, please refer to

Labeling

Canada has specific guidance documents for labeling natural health products. According to this guidance document, the following information needs to be included on the main display panel of the label:

  • Brand name,
  • Product number, dosage form, net weight, etc.
  • The name and address of the brand holder,
  • The name and address of the importer,
  • The generic and specific names of the product ingredients,
  • Ingredients quantities in international units,
  • Recommended purpose of use,
  • Recommended method of use,
  • Recommended dosage,
  • Recommended usage time,
  • Risk information,
  • Recommended storage conditions, and batch number.

For more details, please refer to：Guidance document: Labelling of natural health products  

Products and ingredients

The ingredients of natural health products need to be approved by the Natural and Non-prescription Health Products Directorate (NNHPD). The Canadian Department of Health has established a separate database for raw materials used in natural health products for the purpose of querying the permissible categories of active ingredients in natural health products. For more information, please refer to:

Claims

Natural health products include health claims, functional claims, general health claims, and nutritional function claims. For example, health claims refer to any statement on labels or advertisements that declares, shows, or implies a relationship between consuming a certain food and health.

Health claims and nutritional function claims require approval from the Department of Health to be used in Canada. For more information, please refer to: Pathway for Licensing Natural Health Products Making Modern Health Claims  

Additional Useful Resources

European Union (EU) Laws and regulations for selling dietary supplements:

If your business is located in the European Union, or if you sell dietary supplements to customers in the European Union, then you're required to follow all applicable laws in any jurisdiction where your products are advertised or sold. Before you sell dietary supplements in the European Union, you must comply with the following:

Food supplement refers to a food intended to supplement the normal diet and is a concentrated source of nutrients or other substances with a nutritional or physiological effect, either alone or in combination. This includes, but is not limited to, vitamins, minerals, amino acids, essential fatty acids, fibers, and various plant and herbal extracts.

Food supplements can consist of single ingredients or mixtures and are sold in forms such as capsules, tablets, pills, and other similar forms with small dosages of liquids or powders.

Pre-market notification

Regarding market access for food supplements, most EU countries follow a pre-market notification system. Different countries have different requirements and require food supplements to be notified to the national authorities by the manufacturer. The manufacturer must submit a notification form and provide relevant information, including product labels.

Additionally, pre-market notification for food supplements is not a mandatory requirement but an optional one adopted by individual member states. It is the responsibility of the food supplement manufacturer or the person in charge to ensure compliance, and competent authorities conduct regular market supervision inspections.

 

Labeling

Labeling for dietary supplements must comply with the specific requirements of Directive 2002/46/EC.  

These requirements include:

  • The use of classification names that reflect the true properties or characteristics of the nutrients or substances;
  • The daily recommended intake;
  • Warnings not to exceed the daily recommended intake;
  • A statement that dietary supplements should not be used as a substitute for a varied diet;
  • A statement to keep the product out of reach of young children.

Health Claims

In the EU, health claims for food supplements must comply with the Regulation of Directive 2002/46/EC   and Regulation (EC) No 1924/2006  .

In the EU, the use of specific health claims requires the submission of relevant scientific research materials for review and approval by the European Commission before they can be used for labeling. New health claims not included in the authorized list require a detailed and standardized application and approval procedure established by the EU.

Claims for food supplements must be truthful and must not contain false, exaggerated, or misleading information. They must not claim to prevent or treat diseases, encourage excessive consumption, or use intimidating marketing tactics. The claims must be based on clear scientific evidence.

UK Laws and regulations for selling dietary supplements:

If you sell dietary supplements in UK, then you're required to follow all applicable laws in any jurisdiction where your products are advertised or sold. These additional requirements are laid down in several UK laws, the main one for England being The Food Supplements (England) Regulations 2003  . Substantially similar regulations exist for Scotland, Wales and Northern Ireland.

Food supplements are foods that intend to supplement a normal diet. Supplements have ingredients that have a nutritional or physiological effect, which means that they create a physical effect in the human body. Examples of food supplements include vitamins, minerals, trace elements, amino acids, fibre, plants or herbal extracts.

Food supplements are sold in dosage form as tablets, capsules, coated tablets, powders and liquids intended to be ingested in small, measured amounts.

Requirements to list food supplements

  • The products you sell must be new.
  • All products must comply with all laws and regulations of the UK.

Labeling

The following information should be included on the labeling of food supplements, in addition to the information required under UK Food Information Regulations 2014   and UK retained Regulation on food information for consumers  ：

  • The denomination (also called product type, “Food Supplement”) should be present on the label.
  • The names of nutrients or substances that characterise the product and have a nutritional effect, physiological effect or both.
  • The portion recommended for daily consumption
  • A warning not to exceed the stated recommended daily dose
  • A statement that food supplements must not be used as a substitute for a varied diet
  • A statement that the product should be stored out of reach of young children
  • The amount of the ingredients with a nutritional or physiological effect present in the product. These must be declared in numerical form and per portion of the product as recommended for daily consumption.
  • The information on vitamins and minerals must also be expressed as a percentage of the reference intake values listed in food information for consumers.
  • All food supplement labels must be in English, and in line with UK regulations on labeling (for example, products labeled in compliance with other English-speaking countries such as the US are not compliant for the UK)
  • A list of ingredients, including common allergens  , which must be emphasized
  • A UK food business name and address. It must be one of the following:
    • The name of the business whose name the food is marketed under
    • The address of the business that imported food

For more information, please refer to: the Food Standards Agency (FSA) webpage on food supplements  

Claims

Claims on food supplements must not be false, ambiguous, or misleading and should comply with the relevant requirements.

In general, claims for food supplements must not be false, ambiguous, or misleading about:

  • Quality or size
  • Price
  • Ingredients
  • Date, place and method of manufacture
  • Efficiency (what you say the food can do)
  • The people or organizations that endorse it for supplements, or any health professional endorsement must not indirectly or directly recommend a product or its ingredients.

It is also prohibited to make claims that food or its ingredients can help treat, prevent or cure a disease or adverse condition. In addition, only nutrition and health claims that have been approved under EU Regulation (EC) No 1924/2006   (as retained and amended by UK legislation) can be used on the label and detail page.

Nutrition claims

A nutrition claim is any claim that states, suggests or implies that a food has particular beneficial nutritional properties due to the presence, absence, increased or reduced levels of energy or of a particular nutrient or other substance.

Only nutrition claims listed in the Annex to the EU Regulation (EC) No 1924/2006   (as retained and amended by UK law) can be made for food and only if the product meets with the specific conditions of use for that claim. For more information, please refer to: Guidance on nutrition and health claims on foods  .

Health claims

Nutrition and health claims are only permitted if the average consumer can be expected to understand the beneficial effects as expressed in the claim. A health claim is any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its ingredients and health. Only health claims authorised by the relevant authority as listed below are permitted:

  • England: Secretary of State for Health and Social Care
  • Scotland: Scottish Ministers
  • Wales: Welsh Ministers
  • Northern Ireland: the Department of Health

For England, Scotland and Wales, a register   is maintained by the British authorities, containing a list of specific health claims and the outcome of their assessment (whether authorised or not) as well as their conditions of use.

For Northern Ireland, health claims and their assessments are listed in the EU Register of Health Claims  .

Medicinal claims

Food supplements cannot claim the property of preventing, treating or curing human disease or refer to such properties. Such claims are considered medicinal and medicinal claims are never permitted for food supplements. Only products licensed as medicinal products can bear such claims.

Novel foods and banned ingredients

The Annexes to the Directive 2002/46/EC   (as retained and amended by UK legislation via Nutrition (Amendment etc.) (EU Exit) Regulations 2020  ) list the vitamins and minerals and their chemical forms permitted for use in the manufacture of food supplements.

“Novel foods” for the purposes of UK law are foods that have not been consumed to a significant degree by humans in the UK or EU before 15 May 1997. A novel food can be newly developed, innovative food, food produced using new technologies and production processes, as well as food that is or has been traditionally eaten outside of the UK or the EU.

Novel foods need to be authorised through the GB regulated Products Application Service   before they can be placed on the market in the UK. In addition to novel foods, certain banned and restricted herbal ingredients, particularly those for medicinal use, are not permitted in food supplements.

To ensure that food supplements are safe for consumption, the manufacturer must take into account the upper safe levels established by scientific risk assessment and data on vitamin and mineral intake from other foods.

The UK provides Guidance on Upper Levels for Vitamins and Minerals   from the Expert Group on Minerals and Vitamins.

Additional Useful Resources

Australian laws and regulations for selling dietary supplements:

If your business is located in Australia, or if you sell dietary supplements to customers in Australia, then you're required to follow the Therapeutic Goods Act 1989 (referred to as the Act)   and the Therapeutic Goods Regulations 1990 (referred to as the Regulations).  To further regulate and guide complementary medicines, the Therapeutic Goods Administration (TGA) of Australia issued the Australian Regulatory Guidelines for Complementary Medicines   in 2004.

In Australia, complementary products refer to products that contain certain herbs, vitamins, minerals, nutritional supplements, products of the same therapeutic class, and aromatherapy products.

Complementary medicine means a therapeutic good consisting wholly or principally of 1 or more designated active ingredients, each of which has a clearly established identity and a traditional use.

For more information, please refer to: Overview of the regulation of listed medicines and registered complementary medicines  

Product license

Overseas manufacturers supplying complementary medicines to Australia must meet and comply with the equivalent standards of drug production quality management, known as Good Manufacturing Practice (GMP), required of Australian manufacturers, and obtain TGA approval.

In Australia, there are three regulatory pathways for becoming a complementary medicine: listing (AUST L), assessed listing (AUST L (A)), and registration (AUST R). Products must go through these processes before they can be marketed and sold. Otherwise, they are not permitted for production or sale.

For more information, please refer to: Non-prescription medicines  

Labeling

The requirements for product labels in Australia include the following information:

  • Name of the product,
  • Names of all active ingredients,
  • Quantities or proportions of all active ingredients,
  • Name of the dosage form,
  • Quantity of the product,
  • Expiry date,
  • Storage conditions,
  • Name and contact details of the product applicant or distributor,
  • Relevant warning statements,
  • Usage instructions,
  • Intended purpose of use,
  • Product registration number.

Product Claims

The TGA uses "functional claims" to refer to specific therapeutic uses of complementary medicines. Functional claims describe the intended purpose or health benefits claimed by the product, such as "relieves cough." Functional claims can be specific, such as known non-serious suboptimal health conditions, or non-specific, such as general health maintenance.

For more information, please refer to: Therapeutic Goods (Permissible Indications) Determination (No. 1) 2021  

Products and ingredients

There are certain restrictions and requirements for ingredients in complementary medicines maintained by the TGA. Some limitations may include concentration restrictions, route of administration, plant parts, preparation types, container types, and warning statements.

For more information, please refer to: Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2022  

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