Robert Forbes

Director

RFA Regulatory Affairs

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Changes to regulation of Sports Supplements

A regulatory overview

December 2020

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What has happened?

New Therapeutic Goods Administration (TGA) Section 7 Declaration

that certain sports supplements are therapeutic goods

https://www.legislation.gov.au/Details/F2020C00366

In force 30 November 2020

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Why did it happen?

• Serious adverse events, some fatal, some requiring organ transplants

• Ingredients not appropriate for foods

• Ingredients banned in sport but not declared on labels

• Therapeutic claims made that are not permitted in the food code

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How do I know if my product is affected?

The products affected:

sports goods for oral administration

that are represented as being for the improvement or maintenance of

physical or mental performance in sport, exercise or recreational activity

and that:

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How do I know if my product is affected?

a. Contain … one or more of the following substances:1. a substance included in a schedule to the current Poisons

Standard; or

2. a substance expressly identified on the Prohibited List that is

added as an ingredient to the goods; or

3. a relevant substance that is added as an ingredient to the goods;

or

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How do I know if my product is affected?

4. a substance with equivalent pharmacological action to a substance

mentioned in subparagraph (i), (ii) or (iii), including those that may be

characterised as an active principle, precursor, derivative, salt, ester,

ether or stereoisomer;

or

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How do I know if my product is affected?

b. on or after 30 November 2023, are supplied in the dosage form of a

tablet, capsule or pill other than those goods containing glucose only

And

when the goods are used, advertised, or presented for supply:

a. for therapeutic use; or

b. in a way that is likely to be taken to be for therapeutic use;

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How do I know if my product is affected?

including, but not limited to, one or more of the following therapeutic uses:

• gaining muscle;

• increasing mental focus;

• increasing metabolism;

• increasing stamina;

• increasing testosterone levels, reducing oestrogen levels or otherwise

modifying hormone levels;

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How do I know if my product is affected?

• losing weight or fat;

• preparing for workout;

• recovering from workout

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How do I know if my product is affected?

This is summarised in the amendment to FSSF

1A goods for oral administration that are represented (expressly or by

implication) as being for the improvement or maintenance of physical

or mental performance in sport, exercise or recreational activity, and

that:

(a) contain, or are represented (expressly or by implication)

to contain, one or more of the following substances (however

described or named):

(i) a substance included in a schedule to the current Poisons

Standard; or

(ii) a substance expressly identified on the Prohibited List that

is added as an ingredient to the goods; or

(iii) a relevant substance that is added as an ingredient to the

goods; or

(iv) a substance with equivalent pharmacological action to a

substance mentioned in subparagraph (i), (ii) or (iii),

including those that may be characterised as an active

principle, precursor, derivative, salt, ester, ether or

stereoisomer; or

(b) on or after 30 November 2023, are supplied in the dosage form of

a tablet, capsule or pill, other than those goods containing glucose

only

when the goods are used, advertised, or presented for supply:

(a) for therapeutic use; or

(b) in a way that is likely to be taken to be for therapeutic use;

including, but not limited to, one or more of the following

therapeutic uses:

(c) gaining muscle;

(d) increasing mental focus;

(e) increasing metabolism;

(f) increasing stamina;

(g) increasing testosterone levels, reducing oestrogen levels or

otherwise modifying hormone levels;

(h) losing weight or fat;

(i) preparing for workout;

(j) recovering from workout

Part 2 of Schedule 1 (before table item 1)Insert:

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What claims can I make for Sports Foods?

Definition from the Australia New Zealand Food Standards Code (FSC):

A formulated supplementary sports food (FSSF) means a product that is

specifically formulated to assist sports people in achieving specific

nutritional or performance goals.

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What claims can I make for Sports Foods?

Can make nutritive substance claims BUT health claims limited to 3 very

specific types of Formulated Supplementary Sports Foods (FSSF), no

health claims permitted from Schedule 4 “Nutrition, health and related

claims”• High carbohydrate supplement

• Protein energy supplement

• Energy supplement

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What claims can I make for Sports Foods?

Allowed claims for 3 specific FSSF

High carbohydrate supplement

a) the food is useful before, during, or after sustained strenuous exercise;

and

b) appropriate usage may assist in the provision of energy in the form of

carbohydrates.

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What claims can I make for Sports Foods?

Protein energy supplement

a) the product may assist in providing a low-bulk diet as may be required

during training; and

b) the product may assist in supplementing the diet with a high energy

source as may be required during training; and

c) usage as directed may assist in the development of muscle bulk; and

d) the product is useful before, during, or after sustained strenuous

exercise.

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What claims can I make for Sports Foods?

Energy supplement

a) the product may assist in supplementing the diet with an energy

source as may be required during training; and

b) the product is useful before, during or after sustained strenuous

exercise.

A protein powder that is not a FSSF and qualifies to make health claims in

Schedule 4 of the FSC could claim:

• Contributes to the growth of muscle mass; and

• Necessary for tissue building and repair.

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What do I need to do?

Check if any of your products are caught by the new determination.

If product is fully compliant as a FSSF or general food - it can remain as a

food.

or

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What do I need to do?

If not compliant:

• To remain as a food:

o Revise claims so they are compliant with the FSC

o Reformulate and remove prohibited ingredients

o Change dosage form

or

• Position as a complementary medicine

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What can I claim for a complementary medicine

formulated for athletes?

The Permissible Indications Determination

https://www.legislation.gov.au/Details/F2019L01455

This is a list of all the therapeutic claims (indications for use) permitted for

listed complementary medicines

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What can I claim for a complementary medicine

formulated for athletes?

Examples

• Helps in the maintenance of lean body mass

• Helps improve/promote body metabolism/metabolic rate

• Helps enhance/promote/increase body fat loss

• Aids/assist/helps in the healing of minor muscle injuries

• Decrease/reduce/relieve muscle cramps

• Helps enhance/improve/promote/increase physical/exercise

performance

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To position as a listed complementary medicine:

• All ingredients must be on the list of permitted ingredients

https://www.legislation.gov.au/Details/F2020L01018.

• Reformulation may be required

• Manufacturer must have medicinal GMP: e.g. an Australian TGA

licenced manufacturer, or one of the New Zealand manufacturers that

are acceptable to the TGA, or a manufacturer in any other country

acceptable to the TGA

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To position as a listed complementary medicine:

• You must select one or more of the permitted indications (you must

hold evidence to support the claim)

• TGA application required - AUD$860 application fee (processing time

3-5 days) and annual fee

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TGA information

FAQ:

https://www.tga.gov.au/frequently-asked-questions-sports-supplements-section-7-declaration

This webinar is to be repeated, TGA presentation not yet posted on their website:

https://www.tga.gov.au/webinar-section-7-declaration-certain-sports-supplements-are-therapeutic-goods

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Thank you

Regulatory Affairs Consultants

complementary medicines, foods, cosmetics & medical devices

robert@robert-forbes.com

www.rfareg.com