Should the Government Regulate Vitamins and Herbs
As Drugs?

by the Nutritional Foods Association of Australia

The Issue: "Drug Free"

Amendment 401 to the Therapeutic Goods Regulation was gazetted on 18 December 1997 and specifically makes it illegal to make any representation that a therapeutic product is drug free.


The words 'drug free' or 'drugless remedy' have been in common usage to differentiate the complementary medicine industry from the pharmaceutical drug industry.

In mid 1996 the TGA objected to the use of the words 'drug free' in an advertisement for a herbal remedy 'Arthri-eze' that included fish oil and celery seeds. The advertisement had previously been approved by the Australian Publisher's Bureau (APB) who took the view

"that the general public in reading such advertisements do not regard such substances as drugs - technically though they may be so defined" in definition.
The TGA lodged a complaint with the ASC (Advertising Standards Council) which was then rejected by the ASC noting that this
"was a case of the 'system' getting in the way of the community's general understanding of drugs, both legal and illicit types."
Subsequently the ASC was disbanded, and therefore the TGA's next approach was to claim that the manufacturer was making a false and misleading claim for a product on the basis that the product was regulated as a 'drug'. The manufacturer has since appealed to the Administrative Appeals Tribunal.

A court action by the TGA to prove that the claim 'drug free' for a herbal product is false and misleading, is most likely to fail on the grounds that the public are not being misled. This issue is not one of public safety, it is clearly a market choice issue and therefore is covered by either the Trade Practices Act or the Therapeutic Goods Act both of which prevent false and misleading claims.

The bureaucratic solution: introduce a new law that explicitly makes any representation of drug free illegal.

Government's claim that it is simply 'clarifying' the law is a nonsense.

Key Points

  1. The Industry Association and the manufacturer requested a review by the then Parliamentary Secretary, Dr Bob Woods, of the TGA decision that 'drug free' is not acceptable. Dr Susan Alder of the TGA was appointed as the Minister's delegate and in March 1997 responded that "by definition all therapeutic goods are drugs and therefore by legal definition the statement 'drug free' cannot be accurate if applied to a substance which is a therapeutic good."
  2. Contrary to most other countries in the world, the definition and public's perception is that these preparations are not drugs.
  3. The real issue is about this government regulating vitamin, mineral, herbal and homeopathic preparations as 'drugs'.
  4. A better, more appropriate regulatory model is necessary.
  5. Overseas:
    1. As a result of massive public outcry in the United States, the Dietary Supplements Health Education Act was passed in 1994 that makes it illegal for the FDA to regulate food supplements as drugs unless there are safety issues involved.
    2. The Canadian Health Minister has recently withdrawn a raft of regulations on complementary medicine referring the matter to a Review Committee and citing this was about government listening to the people.
    3. New Zealand regulate their products as "dietary supplements".
  6. The 60% of Australians (Lancet 1996) who use supplements have an inalienable right to proper and reliable information about the products they choose to use. They pay for these products with their after tax dollars, they are no impost on the public purse. On the other hand, the government underwrites the drug industry to the tune of some $3 billion p.a. Understandably the drug industry is keen to stop the use of the words 'drug free' on herbal products.

Options for Industry/Government

  1. Repeal the regulation - The Parliamentary Secretary, Trish Worth, has confirmed the government's decision to make such a claim illegal. The Industry proposed alternative is to develop a code of practice for the use of the words 'drug free' taking account of consumers' perception of the words 'drug free'.
  2. Have the regulation disallowed in the Senate.

Passage of TGR Amendment No.401
through the Senate would be a denial of our democratic right to
responsible and commonsense information on complementary medicines.



This new regulation makes 'drug free' or any similar words illegal on labels and in advertising. It is a long and arduous process working with government to achieve better, more commonsense outcomes for alternative medicine. Sometimes the process gets off the rails, this is one of those times. We now have 10 sitting days of the parliament to have this discriminatory regulation overthrown. We urgently need your support!!

Do two things as quickly as possible:

1. Urgent Petition

Get as many signatures as possible - photocopy the petition form as necessary. Return petition to NFAA or manufacturers reps as soon as possible. We don't know when this will be raised in parliament!

2. State Senators and Local Member: WRITE - FAX - PHONE

Contact your local federal member of Parliament and Senators irrespective of party, tell them that you are annoyed by this demonstrable bias against complementary medicine. The NFAA 'Drug Free' paper outlines the issue; it is vital that you write or fax your comments personally to your politician, form letters are rarely ever acknowledged. A personal letter from a "small business" operator will have a significant effect.

We are on notice, the government doesn't believe we can win this. Let's prove them wrong!

If you don't have the name and phone number of your federal member and senators, ring NFAA (02-6260 4022), Health Minders (02-9542 3144), Bullivants (07-3213 8777) or Blackmores (1 800 803 760) for the information.

Ask your staff to support this important initiative, their long term employment is at risk if government goes down the 'drug' path. This is all about government regulating alternative medicines as drugs.

The Process:

The Parliamentary Secretary, Trish Worth, has told us the government intends to make 'drug free' illegal. If the government won't repeal this law, then our recourse is to ask all opposition Senators, Labor, Greens, Democrats and Independents Harradine and Colston, to have the regulation withdrawn by the Senate. It is absolutely vital that you write/fax/phone your State Senators as well as as your local federal member. Unless we can demonstrate to politicians that there are sufficient people in the community concerned about health freedoms we will not get this disallowed.

Marcus C. Blackmore
Chairman, Government Relations Group
Phone (02)9951 0111

Val Johanson
Executive Director
Phone (02)6260 4022

Nutritional Foods Association of Australia
PO Box 1075
Chatswood  NSW  2067

6 March, 1998