Weight loss products

The best way for most people to lose weight safely and effectively is by eating a healthy balanced diet and increasing physical activity. A weight-loss product is not a ‘magic bullet’ for losing weight and cannot replace either of these lifestyle changes. Weight-loss products are only intended to support the efforts you are making.

If you are thinking about taking a weight-loss product that is a medicine, you should:

• talk to a health professional about alternatives that may be available to you
• make sure you only choose one that is approved for supply in Australia by the Therapeutic Goods Administration (TGA) (one with an AUST L or AUST R number on the label)

What are weight-loss products?

Weight-loss products generally claim, in advertising, to help you lose weight by:

• making you feel full to reduce your appetite, so that you eat fewer calories
• reducing your absorption of nutrients, such as fat or carbohydrates, or calories
• speeding up metabolism or fat-burning, making you burn more calories
• removing water build-up.

Weight-loss products are generally one of the following types.

Keep reading for information about AUST L and AUST R numbers, which are part of the medicine regulation system in Australia.

Weight-loss foods

Food Standards Australia and New Zealand produces the standards that foods must meet, such as the Food for medical purposes standard. This standard applies to very low-calorie foods and diets intended for medically supervised weight-loss through very low-calorie intakes. State and territory food regulators enforce compliance with the food standards.

Some weight-loss products advertised on social media are designed to look like a food but are actually therapeutic goods because of the claims being made about them, the form they come in or the ingredients they contain. You can report suspected non-compliant advertising to the TGA at Report non-compliant advertising.

How are weight-loss medicines regulated?

Under Australian law, many weight-loss products that are not foods are considered to be medicines. Because of this they are regulated by the TGA. This means they must meet quality and safety standards and must be entered on the ARTG to be supplied in Australia.

The Australian Competition and Consumer Commission (ACCC) is also responsible for regulating claims made by businesses about goods or services they sell, including false or misleading claims made about the effectiveness of weight-loss products.

The ACCC and the TGA work together to determine which regulator should take action in each case.

How can I tell if a product is on the ARTG?

The ARTG provides information on therapeutic goods, including weight-loss medicines, that the TGA has approved for supply in Australia. If therapeutic goods are not on the ARTG, they cannot be supplied in Australia.

A product is on the ARTG if one of the following AUST numbers is on the label:

• AUST L − Listed medicines
  • Are considered low risk and are not individually assessed by the TGA before they go on sale. The TGA limits:
    • the ingredients a listed medicine can contain
    • the concentration of the ingredients
    • the health claims that can be made about the medicine.
  • Listed medicines may be reviewed for compliance after they are on sale. This includes review of evidence. Medicines that do not comply with the TGA’s standards may have their listing suspended or cancelled.
• AUST L(A) − Assessed listed medicines
  • Listed medicines with an AUST L(A) number on the label have been individually assessed as being effective for their purpose by the TGA.
  • At the time of publication, there are no assessed listed medicines for weight loss on the ARTG.
• AUST R – Registered medicines
  • Registered medicines with the AUST R number on the label are generally prescription or over-the-counter medicines that have been fully assessed for safety, quality and effectiveness for their purpose by the TGA before they go on sale.
  • These products have strong evidence to support claims that they work to treat the particular condition.

Visit the 'How we regulate medicines ' webpage on the TGA website for more information.

Can weight-loss medicines work?

While weight-loss medicines are not a ‘magic bullet’, some have been shown to support weight loss when combined with eating a healthy balanced diet and increasing physical activity. If you have tried losing weight without success, talk to your healthcare professional for advice.

Several AUST R prescription medicines have been shown to be effective for weight loss and have undergone a detailed assessment by the TGA before being entered on the ARTG.

There are also many AUST L complementary medicines indicated for weight loss on the ARTG, however these are not individually assessed by the TGA before they go on sale. In many cases, there is limited scientific evidence that the ingredients in them are effective to the standards required by the TGA. Most studies so far have not had sufficient trial participant numbers or been conducted over a long enough duration to show that sustained weight loss can be achieved using supplements or herbal medicines.

Unapproved weight-loss medicines

Weight-loss medicines available online may not always be approved for supply in Australia. You therefore cannot trust the medicine’s quality or safety as it has not been accepted by the TGA and may be being supplied illegally.

Unapproved medicines without an AUST L or AUST R number, may be a waste of money and could potentially risk your health because they:

• may not meet Australian manufacturing quality standards
• may contain harmful or dangerous ingredients that are not listed on the label
• may cause unknown side effects
• may contain a different amount of active ingredient than on the label
• may be past their use-by date.

Unapproved products may not meet Australian manufacturing standards

Under Australian law, manufacturers of therapeutic goods must meet strict conditions to ensure the product is manufactured in a clean and safe environment. This is to ensure that products contain only the ingredients listed and that they are not contaminated with other substances.

Unapproved products may be manufactured in non-hygienic environments that do not meet the safety standards. In recent years, the TGA has tested and found unapproved products contaminated with faecal matter, pesticides, heavy metals, plastics and building debris.

Unapproved products may contain hidden and dangerous ingredients

The TGA has tested a range of unapproved products and has found many contain hidden and dangerous substances that are not included in the ingredients list on the label. This means that you can never be sure of what you’re getting in an unapproved product, and some of the ingredients can be a significant risk to your health. These are some examples:

• substances that should only be taken on prescription from a doctor
• allergens not declared on the label
• stimulants
• ingredients that are so harmful they are illegal, such as sibutramine.

The banned ingredient sibutramine

Sibutramine was developed as an appetite suppressant but was withdrawn from most markets in 2010 when it was discovered that the product increases the risk of heart attack and stroke.

Despite being a banned medicine around the world, it has since been found in several unapproved weight-loss products.

In all instances, sibutramine was not included on the product label, and was only discovered when users reported higher rates of heart attacks and stroke, palpitations, high blood pressure, constipation, insomnia, dizziness and anxiety.

These weight-loss products were not approved for Australian supply, and caused harm and, in some cases, death in unsuspecting consumers.

Before you buy a weight-loss medicine

If you are going to buy a weight-loss medicine:

• always talk to a health professional before taking any supplement or medication, as some of the ingredients may interact with medications you may already be taking
• always look for the AUST L or AUST R number which shows that the product is approved for supply in Australia
• be extremely cautious when buying medicines online:
  • Avoid purchasing products from overseas websites
    • manufacturers and suppliers of weight-loss products who operate exclusively overseas do not have to comply with Australian safety and quality requirements, or restrictions relating to advertising. 
  • Make sure you're buying from a legitimate Australian pharmacy or retail outlet.
    • If you’re unsure whether the business is in Australia, check for a physical address of a store (or the head office of an online retailer) when searching the products online.
• don't take medicines that a TGA alert warns are a serious risk to your health and should not be taken.

Advertising rules for weight-loss products

There are strict rules on how therapeutic goods – including weight-loss products – can be promoted and advertised in Australia. These rules are outlined in the Therapeutic Goods Advertising Code.

Under these rules it is illegal:

• to advertise prescription medicines
• to advertise unapproved weight-loss products (those not included on the ARTG) to Australian audiences
• for advertisers to make unrealistic or misleading claims
• to promote an ARTG entered product using claims that are not consistent with its approved use
• to use testimonials in advertising that
  • have been paid for
  • contradict the information on the label or instructions for use
  • suggest it can be used to treat something it is not approved for.

Watch out for misleading and unethical advertising

Advertisers sometimes use unethical practices and scams to get consumers to purchase their products, including fake testimonials, and misleading and unsubstantiated claims. Look out for claims like these in weight-loss ads:

• false promises of unrealistic results, such as
  • lose weight without dieting or exercising
  • lose 10 kilos in 10 days
  • ‘before’ and ‘after’ body images
• images of slim people that imply expected results for all users
• claims that the product can reverse overeating or overconsumption of food or drink
• testimonials that have been paid for or fake testimonials
• offers for free trials if you sign up for direct debit
• promoting the use of prescription medicines that can only be accessed after a consultation with your doctor.

Remember, if it seems too good to be true, it often is.

What is the TGA doing about unsafe weight-loss medicines?

When the TGA finds an unsafe weight-loss product, it can remove it from the ARTG and require the product supplier to recall it from the market.

The TGA can also take enforcement action against companies that:

• make false or misleading weight-loss claims about their products
• sell unapproved products
• sell products with added pharmaceutical ingredients or other undeclared substances
• advertise ARTG entered products with extra unlisted claims
• don’t hold evidence to support their weight-loss claims.

The TGA is taking action against the illegal supply and advertising of weight loss products by:

• stopping illegal products entering Australia. We work closely with the Australian Border Force (ABF) to stop shipments of known risky products. We sample and identify suspect products so future shipments cannot enter Australia. If products subject to a TGA alert are found by the ABF, they will be seized and destroyed.
• publishing safety alerts. We regularly publish safety alerts on known products of concern, which can be searched alphabetically.
• targeting illegal advertising. We work closely with social media and online platforms to remove non-compliant advertising of therapeutic goods.

This reduces the quantity of potentially harmful or ineffective products that are being sold to Australians.

Help the TGA do its job

The TGA wants to hear from you. Information from the public can help us to identify and stop those who breach Australian regulations.

• Advertising − If you suspect a therapeutic good is being advertised in an unethical way, report it to the TGA at Report non-compliant advertising.
• Unapproved product − If you suspect a product you have used or are considering using is not approved for supply in Australia, report it to the TGA at Report non-compliant advertising or Report a problem or side effect.
• Adverse events (side effects) − If you have had an unexpected reaction to a medicine or medication, also called an adverse event, report it to a health professional and to the TGA at Report an adverse event or problem (consumers).

Further information

• Weight-loss product safety: All alerts
• Ozempic (semaglutide) shortage collection
• About Wegovy - the new brand of semaglutide
• Guidance on applying the Advertising Code rules
• Weight loss: beware of buying unregulated products online
• Buyer beware when considering weight-loss products from overseas websites
• If it walks like a therapeutic good, talks like a therapeutic good...
• Information from FDA website: Tainted Weight Loss Products | FDA
• Eat For Health | Australian Dietary Guidelines | NHMRC