Fwd: Nutraingredients.com Article Re Pharmaceuticals Directive Supplement or Mediicne? A Legal Fine Line

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7 Jan 2004 22:29:05 -0000

 

Nutraingredients.com Article Re Pharmaceuticals Directive " Supplement

or Mediicne? A Legal Fine Line

" IAHF.COM "

 

IAHF Webmaster: Breaking News, Whats New, What to Do, All Countries

 

IAHF List: Rob Verkerk of ANH is quoted in the article below by

Nutraingredients.com discussing the immense threat posed by the pharmaceuticals

directive " PD " which threatens to turn any substance with any physiologic effect

in the body into a " drug. "

 

ANH engaged in emergency lobbying recently in an effort to positively amend this

Directive to protect supplements, but it remains to be seen if their efforts

will bear fruit or not.

 

The only chance we have to kill the " PD " is by first overturning the EU Food

Supplements Directive in court.

 

I had a phone conversation yesterday with a concerned person from the IAHF list

in New Jersey who just sent a money order for $500. to ANH. Have you sent ANH a

donation yet, and if not, why not?

 

Do you VALUE your future access to supplements? ANH is the only group in the

world that is fully in our corner on this issue, and they need $20,000. for

their lawsuit. They'll be in court on January 30th, and the whole world will be

impacted by the outcome of this case. Even if you can only afford to donate $25

or so please donate SOMETHING-

http://www.alliance-natural-health.org

 

We CAN win- we have the best lawfirm in the EU working with us, but everyone

needs to do their SHARE and make at least SOME donation. Please forward this to

more people. Many are in DENIAL. Events in the EU WILL impact the world due to

globalization and harmonization. Need more information? Please see my article

about the ANH lawsuit at http://www.iahf.com under Emergency Alert.

 

 

http://www.nutraingredients.com/news/news-NG.asp?id=48854

 

Supplement or medicine? A legal fine line

 

- 07/01/2004 - New European legislation on pharmaceuticals could override the

recently adopted food supplements directive and impact the future of the

supplements industry, according to legal experts.

 

The pharmaceuticals directive (amending Directive 2001/83/EC), which reached a

second reading by the European Parliament on 17 December last year, failed to

include a number of amendments supported by industry assocations that would have

reduced the potential of medicines legislation to govern supplements.

The pharmaceuticals directive contains a definition of a medicinal product (as a

substance that ‘modifies physiological functions’) that has caused much concern

for the food supplement and other industries. Its scope is so wide-ranging that

it could also cover the actions of products such as supplements and cosmetics.

 

While natural health trade assocations last year announced a victory following

the first reading of the directive – they had succeeded in expanding the

definition to better distinguish medicines from food supplements – such

amendments were not included in the second reading.

 

Furthermore, the pharmaceuticals directive will also prevail over any other

legislation in cases where a product comes under its ambit.

 

“As all food supplements would satisfy the definition of ‘medicinal product’ in

the pharmaceuticals directive, there would always be a ‘doubt’ as to which

regime should apply and the proposed article (2,2) of the pharmaceuticals

directive would always resolve that doubt in favour of the pharmaceuticals

directive,” states a legal opinion commissioned by the campaign group Alliance

for Natural Health (ANH).

 

The group has also learned that a clause known as Recital 7 included in the new

directive, which states that medicines legislation should not apply to products

that are ‘clearly’ foods, supplements, cosmetics or medical devices, may not be

binding,

 

“This is a real problem. With an amending directive, the recitals fall away when

merged with the original directive,” Rob Verkerk, director of ANH, told

NutraIngredients.com.

 

“It does not only concern borderline products. The pharmaceuticals directive

actually has total supremacy under the new laws and could be disastrous for the

leading edge of the supplement industry.”

 

The group presented its legal opinion to the European Commission shortly before

the Parliament reading and with support from MEP Avril Doyle has secured

negotiations in the next month to discuss inserting the wording previously

agreed with the Parliament’s environment committee back into the text.

 

Moving to change a directive in such a way after its second reading has little

precedence but ANH believes the Commission ‘will need to come up with an

explanation for this contradiction’.

 

If they do not succeed, a product which is clearly a food supplement could in

future be seriously threatened by classification as a medicine.

 

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