robert forbes - natural health products new zealand · [email protected] . title: slide 1...
TRANSCRIPT
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
www.rfareg.com