The Health Sciences Institute is intended to provide cutting-edge health information.
Nothing on this site should be interpreted as personal medical advice. Always consult with your doctor before changing anything related to your healthcare.

Vitamin supplement regulations

Twilight’s Last Gleaming?

Is your government doing enough to protect you from the dangers of vitamin supplements? The absurdity of that question would be comical if it weren’t the basis of an international drive to severely limit our access to dietary supplements.

In yesterday’s e-Alert I gave you some background on the “European Union Directive on Dietary Supplements” that will become law in August of 2005. Among the 25 European Union (EU) nations (representing more than 450 million people), this directive reclassifies vitamin supplements as “medical drugs,” mandates low dosage levels, and outlaws many supplement ingredients that are currently widely available. Created to “protect” consumers, the directive will do exactly the opposite by denying consumers access to natural therapeutic supplements.

But don’t think you’re off the hook if you live outside the EU. Plans are already underway to bring these extreme regulations to the U.S. and many other countries.

Trying to stay positive

Under the EU directive, a “positive list” has been created to mandate which dietary supplements will be allowed for sale. The list does not include about 350 supplement ingredients, such as boron, a mineral that helps manage symptoms of menopause.

So if you’re a supplement manufacturer in an EU country, and you produce a supplement that contains boron, you’ll be required to remove it from the supplement by August 2005. But there is another option. You can submit a “technical dossier” to argue the case that a particular ingredient (such as boron) should be included on the positive list. Ah, but there’s a catch: The European Commission has made this process so expensive and time consuming that many manufacturers simply can’t afford the costs involved. As a result, many safe formulas and nutrients that have been on the market for decades will soon be banned.

But wait it gets worse

The positive list isn’t really as positive as it sounds.

For instance: Vitamin E made it on the positive list. Sort of. As HSI Panelist Allan Spreen, M.D., has made clear in several e- Alerts, there are a number of different vitamin E forms, and the synthetic form should be avoided for internal use. But according to Euromonitor International, the ONLY form of vitamin E on the positive list is the synthetic form.

And then there’s selenium. Besides the fact that selenium has excellent antioxidant properties that have been shown to help increase insulin efficiency, selenium also enhances the effect of vitamin E, making it a perfect match for any vitamin E regimen. But the only two forms of selenium that made the positive list are – yep – synthetic forms.

Wondering why the positive list emphasizes synthetics? I’ll answer that question with another question: What sort of company specializes in manufacturing synthetic forms of natural treatments? You already saw it coming, didn’t you? The answer: pharmaceutical companies. Large drug companies can easily produce synthetic ingredients at low cost. So the positive list will certainly be positive for drug companies, while many small manufacturers of natural supplements will be forced out of business.

Decoding Codex

The outlook for the future of dietary supplements in Europe is decidedly gloomy. But if you’re a U.S. citizen you might be wondering how all of this will affect you. In fact, the 2005 implementation of the EU directive won’t directly affect consumers outside the EU. But the U.S. and the EU are both members of a much larger club.

The U.S. is one of the 165 member countries of the Codex Alimentarius Commission – an international food standards program created by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). One of the purposes of the Codex Commission is to “harmonize” international food trade. And here are a few key elements of that harmonizing:

  • WHO regards all dietary supplements as “drugs”
  • The Codex Commission has made it clear that it wants to limit over-the-counter sales of dietary supplements while reclassifying others as pharmaceuticals, available only through a pharmacist
  • The U.S. has one vote on the Codex Commission. The European Union represents 27 votes on the commission: the 25 votes of its member countries and 2 votes of the 2 EU candidate countries
  • Under World Trade Organization (WTO) rules, Codex decisions override decisions of individual countries
  • Member countries (including the U.S.) that refuse to “harmonize” with WTO directives may be subject to restrictive trade sanctions
  • The European Union is the United States’ largest trade and investment partner, with a yearly two-way trade in goods and services that is estimated to be nearly $600 billion

“Harmony” never sounded so awful.

Securing the Homeland

The remarkably harsh restrictions of the EU directive on Dietary Supplements have met with an enormous protest from people who correctly see this process as an infringement on their right to make their own health care choices. This past February, the High Court in London ruled that a case challenging the directive should be referred to the European Court – the only court with the authority to challenge EU directives. Exactly when that court will hand down a ruling is not known. What is known is that the decision will have a profound effect on the availability of dietary supplements in Europe and beyond.

Meanwhile, back on the other side of the Atlantic, many congressmen and pro-pharmaceutical organizations have been calling for more restrictive regulations of supplements. So there’s no time to waste in letting our legislators know that we don’t want to see any form of the EU directive taking effect in the U.S.

A complete list of government e-mail and postal addresses is available at a web site called Congress.org. Send a message to your congressmen and let them know that we want no part of international “harmonizing” that restricts our access to supplements. And most importantly, tell them that you don’t need any government or international organizations to “protect” you from your personal health care choices.

Sources:
“Directive 2001, EC of the European Parliament and of the Council on the Approximation of the Laws of the Member States Relating to Food Supplements” European Parliament Session Document C5-0640/2001, 12/10/01
“Food Supplements Directive Set to Overhaul Europe” Kathrin Jungbeck, Euromonitor International, 6/15/04, euromonitor.com

Get a free copy of 5 Household Items that Cause Cancer

By texting HSI to 844-539-1128, you are providing your electronic signature expressly consenting to be called and texted (including by prerecorded messages, using an autodialer, and/or automated means) with alerts, stories, reports, and marketing communications from Institute of Health Sciences, LLC. and its authorized representatives at the phone number you provide, including landlines and wireless numbers, even if the phone number is on a corporate, state or national Do Not Call list. You also consent and unconditionally agree to our Privacy Policy and Terms of Use, including the arbitration provision and class action waiver contained therein. Msg&data rates may apply. 15 Msgs/Month. You are not required to agree to this as a condition of making a purchase.

Terms & Conditions

The following Terms and Conditions apply to your use of the website located at hsionline.com (the “website”) and any text messages that you send to or receive from the Institute of Health Sciences, L.L.C. These Terms and Conditions constitute a binding agreement (“Agreement”) between you (“you”) Institute of Health Sciences, L.L.C (“we”, “us”, etc.)  Please read these terms carefully. 

By providing your telephone number to us, texting us a short code listed on the website, or otherwise indicate your agreement to these Terms and Conditions, you are agreeing to the mandatory arbitration provision and class action waiver below. 

ARBITRATION IS MANDATORY AND THE EXCLUSIVE REMEDY FOR ANY AND ALL DISPUTES RELATED TO THIS WEBSITE, THIS AGREEMENT, AND ANY TELEPHONE CALLS, EMAILS, OR TEXT MESSAGES THAT YOU RECEIVE FROM OR ON BEHALF OF US, UNLESS SPECIFIED BELOW OR UNLESS YOU OPT-OUT.

Text Messaging and Telemarketing Terms and Conditions

When you provide your telephone number on this website or send a text message to us with or from a short-code, you agree to receive alerts and communications, and marketing messages including those sent via automated telephone dialing system, text messages, SMS, MMS, and picture messages from Institute of Health Sciences, L.L.C at the phone number you provide on this website or the phone number from which you text the short code, including on landlines and wireless numbers, even if the phone number is on a corporate, state or national Do Not Call list. You also agree to the mandatory arbitration provision and class action waiver below. Your consent is not required to purchase goods or services. Message & data rates may apply.

You may opt-out at any time by texting the word STOP to the telephone number from which you receive the text messages.  Call 1-888-213-0764 to learn more.  By providing your telephone number, you agree to notify us of any changes to your telephone number and update your account us to reflect this change. Your carrier may charge you for text messages and telephone calls that you receive, or may prohibit or restrict certain mobile features, and certain mobile features may be incompatible with your carrier or mobile device. Contact your carrier with questions regarding these issues.

Dispute Resolution by Binding Arbitration and Class Action Waiver

Any dispute relating in any way to telephone calls, emails, or text messages that you receive from or on behalf of Institute of Health Sciences, L.L.C this website, or this Agreement (collectively “Disputes”) shall be submitted to confidential arbitration and shall be governed exclusively by the laws of the State of Maryland, excluding its conflict of law provisions.  For the avoidance of doubt, all claims arising under the Telephone Consumer Protection Act and state telemarketing laws shall be considered “Disputes” that are subject to resolution by binding individual, confidential arbitration.

If a Dispute arises under this Agreement, you agree to first contact us at 1-888-213-0764 or help@hsionline.com. Before formally submitting a Dispute to arbitration, you and we may choose to informally resolve the Dispute.  If any Dispute cannot be resolved informally, you agree that any and all Disputes, including the validity of this arbitration clause and class action waiver, shall be submitted to final and binding arbitration before a single arbitrator of the American Arbitration Association (“AAA”) in a location convenient to you or telephonically. Either you or we may commence the arbitration process by submitting a written demand for arbitration with the AAA, and providing a copy to the other party.  The arbitration will be conducted in accordance with the provisions of the AAA’s Commercial Dispute Resolutions Procedures, Supplementary Procedures for Consumer-Related Disputes, in effect at the time of submission of the demand for arbitration.  Except as may be required by law as determined by the arbitrator, no party or arbitrator may disclose the existence, content or results of any arbitration hereunder without the prior written consent of both parties. Institute of Health Sciences, L.L.C will pay all of the filing costs.  Without limiting the foregoing, YOU EXPRESSLY AGREE TO SUBMIT TO ARBITRATION ALL DISPUTES RELATING TO ANY TEXT MESSAGES OR TELEPHONE CALLS YOU RECEIVE FROM OR ON BEHALF OF US OR ANY ENTITY WITH WHOM WE MAY SHARE YOUR TELEPHONE NUMBER.  Further, we both agree that all entities with whom we share your telephone numbers shall be third party beneficiaries of this Agreement to Arbitrate Disputes, and that those entities have the same rights as Institute of Health Sciences, L.L.C to enforce this arbitration provision.

Notwithstanding the foregoing, the following shall not be subject to arbitration and may be adjudicated only in the state and federal courts of Maryland: (i) any dispute, controversy, or claim relating to or contesting the validity of our or one of our family company’s intellectual property rights and proprietary rights, including without limitation, patents, trademarks, service marks, copyrights, or trade secrets; (ii) an action by us for temporary or preliminary injunctive relief, whether prohibitive or mandatory, or other provisional relief; (iii) any legal action by us against a non-consumer; or (iv) interactions with governmental and regulatory authorities.  You expressly agree to refrain from bringing or joining any claims in any representative or class-wide capacity, including but not limited to bringing or joining any claims in any class action or any class-wide arbitration.

The arbitrator’s award shall be binding and may be entered as a judgment in any court of competent jurisdiction. To the fullest extent permitted by applicable law, no arbitration under this Agreement may be joined to an arbitration involving any other party subject to this Agreement, whether through a class action, private attorney general proceeding, class arbitration proceedings or otherwise.

YOU UNDERSTAND THAT YOU WOULD HAVE HAD A RIGHT TO LITIGATE IN A COURT, TO HAVE A JUDGE OR JURY DECIDE YOUR CASE AND TO BE PARTY TO A CLASS OR REPRESENTATIVE ACTION.  HOWEVER, YOU UNDERSTAND AND AGREE TO HAVE ANY CLAIMS DECIDED INDIVIDUALLY AND ONLY THROUGH ARBITRATION.  You shall have thirty (30) days from the earliest of the date that you visit the website, the date you submit information to us through the website, or the date that you send a text message to us, to opt out of this arbitration agreement, by contacting us by email at help@hsionline.com or by mail Health Sciences Institute, PO Box 913, Frederick, MD 21705-0913. If you do not opt out by the earliest of the date that you visit the website, the date you submit information to us through the website, or the date that you send a text message to us, then you are not eligible to opt out of this arbitration agreement.

Electronic Signatures

All information communicated on the website is considered an electronic communication.  When you communicate with us through or on the website, by text message or telephone, or via other forms of electronic media, such as e-mail, you are communicating with us electronically.  You agree that we may communicate electronically with you and that such communications, as well as notices, disclosures, agreements, and other communications that we provide to you electronically, are equivalent to communications in writing and shall have the same force and effect as if they were in writing and signed by the party sending the communication.

You further acknowledge and agree that by clicking on a button labeled “ORDER NOW”, “SUBMIT”, “I ACCEPT”, “I AGREE”, “YES”, by texting a short code to us in response to a request on this website, or by clicking or similar links or buttons, you are submitting a legally binding electronic signature and are entering into a legally binding contract.  You acknowledge that your electronic submissions constitute your agreement and intent to be bound by this Agreement.  Pursuant to any applicable statutes, regulations, rules, ordinances or other laws, including without limitation the United States Electronic Signatures in Global and National Commerce Act, P.L. 106-229 (the “E-Sign Act”) or other similar statutes, YOU HEREBY AGREE TO THE USE OF ELECTRONIC SIGNATURES, CONTRACTS, ORDERS AND OTHER RECORDS AND TO ELECTRONIC DELIVERY OF NOTICES, POLICIES AND RECORDS OF TRANSACTIONS INITIATED OR COMPLETED THROUGH THE WEBSITE.  Furthermore, you hereby waive any rights or requirements under any statutes, regulations, rules, ordinances or other laws in any jurisdiction which require an original signature, delivery or retention of non-electronic records, or to payments or the granting of credits by other than electronic means You may receive a physical paper copy of this contract by contacting us at help@hsionline.com.

Privacy Policy

Please read our Privacy Policy, which is incorporated herein by reference.  In the event of any conflict between these Terms and Conditions and the Privacy Policy, these Terms shall control.

Contact Us

You may contact us by telephone at 1-888-213-0764 or by email at help@hsionline.com.