Joint Health Products

What is it used for?

Refer to Tables 2 and 3.

• It is mandatory for all products to cite at least one use or purpose statement from Table 2.

• A use or purpose statement is acceptable only if at least one active ingredient associated with that statement is present at a dose at or above the minimum daily dose listed in Table 2.

• active ingredients which do not meet the minimum daily dose for a use or purpose statement will be considered as acceptable complementary active ingredients in product formulations.

• For multi-ingredient products:

  • To prevent the product from being represented as a "traditional medicine", any indicated traditional use claim must refer to the specific active ingredient(s) and recognized traditional system of medicine from which the claim originates when 1) both traditional and modern claims are present or 2) when claims originate from multiple systems of traditional medicine (e.g., Turmeric is traditionally used in Herbal Medicine to help relieve joint pain).

  • When ALL of the active ingredients (MIs) in the product are used within the SAME identified system of traditional medicine AND the product makes ONLY traditional claims, listing of MIs in the traditional claim(s) is not required.

What this guide covers

this reference is intended to serve as a guide to industry for the preparation of product documentation for supplement market authorization.

• this reference may be used to support single ingredient or multi-ingredient products. However, it is mandatory for joint health products to contain at least one active ingredient from Table 2 at therapeutic dose with its associated claim(s).

• As enhanced absorption formulations are often used for Turmeric and its constituents, this is a reminder that enhanced absorption dosage forms/formulations are not covered by Natural and Non-prescription Health Products Directorate's references and should be submitted as Class III submissions with supporting evidence.

Who does this guide cover?

Adults 18 years and older

How is it taken?

Oral

Which forms are covered?

this reference excludes foods or food-like dosage forms as indicated in the Compendium of references Guidance Document.

Quantities

Refer to Tables 2 and 3.

Note: When ‘decoction’ or ‘infusion’ is listed as an acceptable method of preparation, ‘decoction concentrate’ or ‘infusion concentrate’ is also allowed. It also applies to standardized methods of preparation.

¹At least two of the following references were consulted per use or purpose: EMA 2017; Bruyère et al. 2012; Benito-Ruiz et al. 2009; Yoshida et al. 2009; Clark et al. 2008; Winston and Kuhn 2008; Herrero-Beaumont et al. 2007; Mazières et al. 2007; Sontakke et al. 2007; Towheed and Anastassiades 2007; Kim et al. 2006; Mills and Bone 2005; Uebelhart et al. 2004; Usha and Naidu 2004; Braham et al. 2003; ESCOP 2003; Hoffmann 2003; Kimmatkar et al. 2003; Pavelka et al. 2002; Sato et al. 2002; Mazières et al. 2001; Reginster et al. 2001; Thie et al. 2001; Blumenthal et al. 2000; Mills and Bone 2000; Volker et al. 2000; Houpt et al. 1999; Bourgeois et al. 1998; Bucsi and Poor 1998; Uebelhart et al. 1998; Sköldstam et al. 1992; Deodhar et al. 1980. ²At least one of the following references was consulted per minimum dose: EMA 2017; Bruyère et al. 2012; Benito-Ruiz et al. 2009; WHO 2009; Yoshida et al. 2009; Clark et al. 2008; Kalman et al. 2008; Herrero-Beaumont et al. 2007; Mezieres et al. 2007; Sontakke et al. 2007; Fitzpatrick 2005; Mills and Bone 2005; Boon and Smith 2004; Uebelhart et al. 2004; Usha and Naidu 2004; Wichtl 2004; ESCOP 2003; Hoffmann 2003; Kimmatkar et al. 2003; Williamson 2003; Barnes et al. 2002; Pavelka et al. 2002; Mezieres et al. 2001; Reginster et al. 2001; Blumenthal et al. 2000; Volker et al. 2000; Houpt et al. 1999; Bucsi and Poor 1998; Uebelhart et al. 1998; Deodhar et al. 1980. ³At least one of the following references was consulted per maximum dose: EMA 2017; Bruyère et al. 2012; Benito-Ruiz et al. 2009; WHO 2009; Clark et al. 2008; Sato et Iwaso 2008; Herrero-Beaumont et al. 2007; Sontakke et al. 2007; Hathcock and Shao 2006; Kim et al. 2006; Mills and Bone 2005; Boon and Smith 2004; Wichtl 2004; Braham et al. 2003; ESCOP 2003; Kimmatkar et al. 2003; Williamson 2003; Barnes et al. 2002; Pavelka et al. 2002; Sato et al. 2002; Reginster et al. 2001; Blumenthal et al. 2000; Bourgeois et al. 1998; US FDA 1997; BHC 1992; Deodhar et al. 1980. ⁴Turmeric: Refer to the Turmeric reference for more information on native extracts. ⁵Fish oil: The EPA:DHA ratio for fish oil must be between 0.5:1 and 2:1 [Source note 5] and potency must be expressed as the quantity (mg) and/or percent (%) of EPA and DHA (% w/w) relative to the total quantity of fish oil.

*Note: For Devil's claw and Turmeric, solvents allowed for the method of preparation "Non-standardized extracts (Dry extract)" as part of this reference are ethanol and/or water only.

The following claims are only acceptable in addition to at least one claim from Table 2 above. A joint health product cannot contain only ingredients and claims from Table 3.

¹At least two of the following references were consulted per use or purpose: HC 2018; Hunt 2012; FDA 2008; Tang et al. 2007; IOM 2006; NAMS 2006; Shils et al. 2006; Devirian and Volpe 2003; Brown and Josse 2002; Walker et al. 2002; Groff and Gropper 2000; NIH 2001; Blumenthal 1998; IOM 1997; Nielsen et al. 1987. ²At least one of the following references was consulted per minimum daily dose: HC 2018; Hunt 2012; IOM 2006; Walker et al. 2002; Blumenthal 1998. ³At least one of the following references was consulted per maximum daily dose: HC 2018; Hunt 2012; IOM 2006; Kerkhoffs et al. 2004; Singer et al. 2001. ⁴Boron: Specific rule for boron for products providing more than 0.7 mg of boron per day. Refer to the ‘Notes’ section below. ⁵Bromelain: One papain unit (PU) is defined as that quantity of enzyme that liberates the equivalent of 1 microgram of tyrosine per hour under the conditions of the assay. One gelatin digestion unit (GDU) is approximately equivalent to 15,000 FCC papain unit (1 GDU ≈ 15,000 FCC PU). The quantity per dosage unit must be the enzymatic activity. The quantity of the enzymatic preparation in mg or ml may also be included as additional quantity

• The above uses can be combined on the product label (e.g. Helps maintain joint health and reduce joint pain associated with osteoarthritis).

• The terms ‘Helps’ or ‘Helps to’ can be used interchangeably on the label.

• Specific rule for products providing more than 0.7 mg of boron per day: in order to ensure a favorable risk-benefit profile, a product providing elemental boron at doses in excess of 0.7 mg and up to the maximum limit of 3.36 mg per day must:

  • be a joint health product;

  • contain at least one active ingredient from Table 2; and

  • make only the specified joint pain/health claims from Table 2. In addition, the claim associated with boron ‘Helps maintain healthy calcium metabolism’ can be included.

  Other health products such as multi-vitamin/mineral supplements must not provide more than the maximum limit of 0.7 mg elemental boron per day.

How is it used?

¹The following references were consulted for the directions for use: Boron: Devirian and Volpe 2003; Zittermann 2003; Calcium: Brayfield and Cadart 2025, IOM 2011, ASHP 2005; MSM: Kim et al. 2006.

How long is it used?

• A minimum duration of use statement is required for all products citing use or purpose statements associated with boswellia, chondroitin sulfate, devil's claw, glucosamine (hydrochloride and sulfate), hydrolyzed collagen or methylsulfonylmethane (MSM).

• If more than one minimum duration of use is required for a particular product formulation, the shortest minimum duration of use must be the only one listed on the label since they are associated with similar uses.

• A maximum duration of use statement is required for all products containing bromelain or willow bark. If the maximum duration of use is shorter than the minimum duration of use to see beneficial effects, the associated claim cannot be included. If more than one maximum duration of use is required for a particular product formulation, the shortest maximum duration of use statement must be the only one listed on the label.

Minimum duration(s) of use

¹At least one of the following references was consulted per duration of use: Bruyère et al. 2012; Benito-Ruiz et al. 2009; Clark et al. 2008; Bjordal et al. 2007; Mehta et al. 2007; Sontakke et al. 2007; Kim et al. 2006; Usha and Naidu 2004; ESCOP 2003; Kimmatkar et al. 2003; Houpt et al. 1999; Qiu et al. 1998.

Maximum duration(s) of use

Products providing 60,000,000 FCC PU or less bromelain, per day

Ask a healthcare professional for use beyond 16 weeks [Source note 6].

Products providing more than 60,000,000 FCC PU bromelain, per day

Ask a healthcare professional for use beyond 4 weeks.

Products containing willow bark

Ask a healthcare professional for use beyond 6 weeks [Source note 7].

Warnings and precautions

Products providing more than 2.8 g of hydrolyzed collagen per day or any other active ingredient from Table 2 at any dose (except products containing willow bark requiring a contraindication)

Ask a healthcare professional before use if you are pregnant or breastfeeding.

(Joint) pain (and swelling) associated with osteoarthritis or rheumatoid arthritis

Ask a healthcare professional if symptoms worsen.

Joint inflammation/anti-inflammatory/minor pain, swelling and inflammation relief

Ask a healthcare professional if symptoms persist or worsen.

Products containing following active ingredients

¹The following references were consulted for the caution and warning statements: beta-Carotene: Touvier et al. 2005; Omenn et al. 1996; ATBC 1994; Boron: Usuda et al. 1996; Nielsen et al. 1992; Bromelain: Brinker 2010; Blumenthal et al. 2000; Curcumin: HC 2025; Brinker 2010; Mills and Bone 2005; ESCOP 2003; McGuffin et al. 1997; Fish oil and willow bark combined: Block et al. 2012, 2013; Larson et al. 2008; Manganese: IOM 2006; IOM 2001; Krieger et al. 1995; Turmeric: HC 2025; EMA 2018; Brinker 2010; ESCOP 2003; McGuffin et al. 1997; Vitamin K1, K2: ASHP 2005; Franco et al 2004; IOM 2001; Hansten et al 1997; Willow bark: EMA 2017.

When should it be avoided?

Products containing willow bark

• Do not use if you are pregnant or breastfeeding [Source note 8].

• Do not use if you are allergic to salicylates (EMA 2017; Brinker 2010; Wichtl 2004, ESCOP 2003; Barnes et al. 2002; Blumenthal et al. 2000).

Possible side effects

Products containing boswellia and/or bromelain

Stop use if hypersensitivity/allergy occurs [Source note 9].

Products containing boswellia; bromelain; hydrolyzed collagen; methylsulfonylmethane and/or willow bark

When using this product you may experience gastrointestinal discomfort/disturbances [Source note 10].

Products providing more than 350 mg magnesium per day

When using this product you may experience diarrhoea (IOM 2006, IOM 1997).

Storage

Must be established in accordance with the requirements described in the applicable product regulations.

Products containing fish oil, except those encapsulated

Refrigerate after opening [Source note 11].

Products containing fish oil (information for industry; not for labelling)

To be packaged in airtight container, protected from light [Source note 12].

Products containing hydrolyzed collagen (information for industry; optional for labelling depending on the packaging)

To be protected from heat and moisture [Source note 13].

Conditions for combined preparations

• For multi-ingredient products containing bromelain and papain, the combined proteolytic activity should not exceed the maximum proteolytic activity of 130,000,000 FCC PU per day and 45,000,000 FCC PU per single dose.

• The finished product should not exceed a total amount of curcuminoids of 500 mg per dose and 1500 mg per day.

• The finished product should not exceed a total amount of curcumin of 400 mg per dose and 1200 mg per day.

• The daily dose for glucosamine hydrochloride in combination with glucosamine sulfate is subject to the following limitations: the sum of the percentages of their individual maximum daily doses must not exceed 120%; [e.g. a product providing a daily dose of 2000 mg glucosamine hydrochloride (100% of the 2000 mg maximum daily dose) + 300 mg glucosamine sulfate (20% of the 1500 mg maximum daily dose) would be acceptable (100%+20%=120%)].