09/15/06 - "promotes and markets... for serious disease conditions"

09/15/06 - VITAMIN LAWYER UPDATE e-MEMO

VLN - http://www.vitaminlawyernews.com http://vitaminlawyerhealthfreedom.blogspot.com/

The FDA issued the following press release last week: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01446.html

Excerpts:

"At the request of ...(FDA), on September 5, 2006, U.S. Marshals seized quantities of Ellagimax capsules, Coral Max capsules, Coral Max without Iron capsules, and Advanced Arthritis Support capsules... valued at approximately $55,000.00."

[Note the following claim that the NEW drug and misbranding provisions apply to dietary supplements as well as to drugs, when the DS is being promoted, in FDA's opinion, as a "drug."]

"The products are alleged to be in violation of the new drug and misbranding provisions of the Federal Food, Drug and Cosmetic Act."

"Although these products are labeled as "dietary supplements," they are being promoted with claims typically associated with drug products. These claims are evident in the products' labeling, including various promotional literature, an audio cassette tape, and two Internet Web sites owned and used by the firm. ..."

"[Company's] labeling promotes and markets these products for serious disease conditions, including but not limited to cancer, arthritis, fibromyalgia and seizures."

[And now, what to expect.]

"Following an investigation of the firm's marketing practices, FDA advised Advantage Nutraceuticals that the claims related to prevention or treatment of diseases in many of its products' labeling make these products subject to regulation as drugs. Despite FDA's warnings, the firm failed to take sufficient steps to come into compliance with the Act. During subsequent inspections, FDA inspectors found that the offending claims were still being made."

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Note that "sufficient steps to come into compliance..." was the issue. This case appears to be another example of "guilty until proven innocent" in that no independent third party determined that the steps the company took were "sufficient." The companies that will survive in what is becoming a much stricter regulatory climate are those that are ready to react quickly. Oh, and if you are one of those companies trying to take "sufficient steps," not keeping a large inventory in your main plant is probably a good idea too.

You need to pay attention to your site claims on a continuing basis, and that is what the Vitamin Lawyer Oversight Seal program is all about. See: http://www.vitmainlawyer.com for details.

09/08/06 - AERs and QCs - more regs for industry

09/08/06 - VITAMIN LAWYER UPDATE e-MEMO

For those of you who are new to the VLUM, the purpose of this e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. You got on this e-list by opting in or becoming a client of the Vitamin Lawyer Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own elist…R

Here are the items I am covering in this e-memo:

1. Adverse Event Reporting – the latest on the bill to grant the FDA new powers to control Vitamins.
2. Ephedra re-banned!
3. The Vitamin Lawyer Oversight Seal and Quality Control (QC) Practices.

1. ADVERSE EVENT REPORTING

Is "AER" coming to the Dietary Supplement world? The Dietary Supplement and Non-Prescription Drug Consumer Protection Bill, S.3546 was introduced on June 21st and was put on the Legislative Calendar on September 5th. It is expected to be voted on before the election this November.
Says FDA News: “The Senate is planning to vote on one drug safety bill this week and another before the end of the month, a spokesman for Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Mike Enzi (R-Wyo.) said. First up will be "The Dietary Supplement and Nonprescription Drug Consumer Protection Act," which would amend the Federal Food, Drug, and Cosmetic Act (FDCA) to require OTC and dietary supplement companies to provide notice of serious adverse events to the FDA. The bill… is expected to go to the Senate floor this week..” Some suggest that AER will be bad for the industry and I understand their concerns: nutrients are foods and should not be subjected to “drug-like” controls. But consider, if AER rules had been in place a decade ago, would Tryptophan have been banned because one manufacturer made one bad batch? Would Ephedra have been banned if a reporting system had been in place to show the actual safety of that herb, when used as directed? You can get more information at: http://www.aer-consultants.com.

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2. EPHEDRA RE-BANNED!

An appeals court has just overturned Judge Campbells’ well-reasoned decision from April 2005, that “…the legislative history of the DSHEA indicates that Congress generally intended to harmonize the treatment of dietary supplements with that of foods when it added the dietary supplement subsection...” This appeal court action is being appealed further to the US Supreme Court that will thereby have an opportunity to confirm that Nutrients are Foods, not Drugs!

3. QC and the VITAMIN LAWYER OVERSIGHT SEAL

An important part of the developing “Current Good Manufacturing Practices” (cGMPs) in the vitamin industry is Quality Control. The Vitamin Lawyer has developed format Operations Manual sections for QC that tracks FDA requirements and the probable requirements of the AER bill. One of the keys to meeting the new requirements will be standardized QC controls – in a manual format for the FDA to review if (and when) they come to your plant for a surprise inspection. Please contact me if you need help with your Operations Manual.

One way to assure your customers quality claims is to qualify for and post the Vitamin Lawyer Oversight Seal -- the seal is proudly displayed on web sites that meet exacting standards for claim language and disclaimer usage. See www.vitaminlawyer.com for a sample of the Seal. The Vitamin Lawyer’s monthly retainer clients not only have the privilege of using the Oversight Seal, but also receive discounted rates for services. Let me know if you are interested.

That’s all for now. Have a great autumn!

07/05/06 - FDA inspections & SoPs - Operations Manua

07/05/06: VITAMIN LAWYER UPDATE e-MEMO

This Vitamin Lawyer Update is addressed primarily to the Dietary Supplement formulators and marketers on my eList.

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1. FDA Inspection - What to expect from an FDA site inspection
2. Codex Meeting in Geneva - Latest internationalist regulations
3. SoP- Operations Manual - Why a good SoP Manual helps with QC requirements.

Updated: www.VitaminIndustryCompliance.com

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1. FDA inspections

According to the respected vitamin industry publication FDA News, "The FDA conducted more than 19,000 inspections, issued more than 6,000 Form 483s and sent out 535 warning letters in fiscal 2005 alone. With an estimated $22 million in new user fees in 2007, the FDA plans to fund increased reinspections and follow-up work."

While most of these inspections are in the other areas FDA regulates: drugs, cosmetics, OTCs and devices, the number of inspections are increasing in the Vitamin industry as well.

So, how do you prepare for a possible inspection?

Primarily by having your physical location clean and orderly while making sure your paper work is in order.

This is what FDA will look for:

1. Quality Control to assure that every product is tested upon receipt from manufacturer
2. Complaint procedures to ensure that all adverse reactions are identified
3. Training programs for customer service and sales people
4. Disclaimers must be located at the site of the claim
5. New dietary ingredient, structure and function and health claim filings
6. Copies of labels and ads will be required to be provided.

See: http://www.lifespirit.org/fdainspection.htm

Of the above, the most important are probably:

1. Copies of your Structure and Function Notices to the FDA (this notice is required within 30 days of whenever you make or change a claim made about a dietary ingredient). Up 'til now, FDA has not had the resources to police the S&F Notice requirement so few marketers file them; I recommend that marketers do prepare and file these notices for at least their most important products. Of course, The Vitamin Lawyer has proper formats for the notice; estimate: about 1 hour legal time to do a notice properly.

2. Copies of your labels and ads.

3. Operations Manual – including QC, complaint (adverse reaction) and staff training information; a standard Employee Manual and the Rules for your online affiliation program could be part of this too. The Vitamin Lawyer has the proper formats available for much of this.

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2. Codex Meeting in Geneva

The Codex Commission is meeting this week in Geneva. The international organization appears to be increasingly chaotic as various nations try to assert their interests against the globalizing interests of the US and EU.

From the standpoint of the US Dietary Supplement industry, the most important development thus far at the meeting was an admission by the Codex Secretary that, in the proposals before the Commission, “No sentence provides that Codex standards and related guidelines are mandatory…” This admission, in keeping with the provision in the Codex Statute that its guidelines are “advisory” means the US supplement industry can continue to develop regardless of international regulations – so long as Congress does not adopt those restrictive international norms, or permit the FDA to “backdoor” those restrictions under the guise of “harmonization.”

For an up-to-date report on one observer’s view of what is happening in Geneva, see: http://blog.healthfreedomusa.org/.

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3. SoPs Manual - Standard Operating Procedures

The summer time tends to be a little less hectic than other times of the years, so this might be the best time for you to engage the Vitamin Lawyer in preparing your Operation Manual so you can be ready in the event of a surprise FDA visit. Good Quality Control (QC) procedures necessitate the existence of an Operations Manual. My simple format for small supplement purveyors includes the following sections.

A. Refund, Delivery & Returns Policies
B. Standard Disclaimers; Site Use Statement
C. Standard Testimonial Waiver
D. Email Privacy Policy
E. Document Retention Policy
F. Quality Control Procedures - Standards, Complaints and Policy Coordination
G. Order Processing Procedure
H. Bookkeeping and Account Management
I. Order Record Keeping and Retrieval; AER Reporting
J. Emergency Planning and Crisis Management [added 11/16/06]

Contact me at ralph.fucetola@usa.net if you want a customized OPs Manual; please put "Op Manual" in the subject line.

[03/16/07 update: For an outline of the VL standard SoP and Employee Manual, see: http://tinyurl.com/2eu6yj.]

Well, that’s all for now.

Ralph Fucetola JD
http://www.vitaminlawyer.com

06/08/06 - SEO, FTC Policing Claims, SUS Updates

06/08/06 - VITAMIN LAWYER UPDATE e-MEMO

1. Search Engine Optimization
2. FTC to Police Vitamin Claims
3. Citizen's Health Freedom Petition
4. Site Use Statement Updates

This memo is going out to the Vitamin Lawyer eList. If you do not want to receive occasional information from me, please let me know. The purpose of the Vitamin Lawyer Update Memo is to keep my client base and others involved in the nutritional and complementary markets up-to-date on developments.

1. SEO - Search Engine Optimization - Since many recipients are Internet marketers, I often provide information about optimizing search engine ranking. At the end of this email is a copy of a recent piece from Entire Web that I think you will find interesting. Link to Article.

2. The FTC is getting more active in the vitamin world - "Lee Peeler, Deputy Director of the FTC’s Bureau of Consumer Protection, said [in Congressional testimony], “Although many supplements offer the potential for real health benefits to consumers, unproven products and inaccurate information can pose a threat to the health and well-being of consumers and cause economic injury.”

“The Commission has focused its enforcement priorities on national advertising claims for products with unproven benefits; products promoted to treat or cure serious diseases; products that may present significant safety concerns to consumers; and products that are deceptively marketed to or for children and adolescents,” the testimony stated. The FTC has filed fourteen complaints in the past year against companies making allegedly unsubstantiated or false advertising claims for dietary supplements and other natural healthcare products, including oral sprays, creams, and patches. Also, in the past year, the Commission obtained orders against forty companies and forty-four individuals, which prohibited the unlawful practices and required the defendants to pay a total of $35.5 million in consumer redress, disgorgement, and civil penalties."

Please read the above , again, carefully… “a word to the wise…”

3. Health Freedom – Here’s a link to the Citizen’s Petition pending before the FDA on certain health freedom issues.

http://www.fda.gov/ohrms/dockets/dockets/05p0433/05p-0433-sup0002-vol1.pdf

4. Note to clients: If you haven't had your web Site Use Statement (Disclaimer / Disclosure / Privacy statements) reviewed in over a year, you should consider having it reviewed. I've added several paragraphs to my standard SUS format to cover recent changes in the law, including the recent Food Allergens Notification law and some even more esoteric developments.

www,SiteUseStatement.com

Ralph Fucetola JD
www.vitaminlawyer.com

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Basic On-Page Search Engine Optimization - www.entireweb.com

There are 2 different types of search engine optimization, on-page and off page. Here you'll learn the differences between them, and basic tips to getting your website optimized for the search engines.

What Is The Difference Between On-Page And Off-Page Search Engine Optimization

The difference is that on-page optimization involves changing elements of your actual webpages that most visitors to your site wont even notice. For example, having your keywords in specific places or writing the title a certain way. Basically it's tweaking all elements of a page which are a factor for ranking well in the search engines.

Where as off-page optimization , is partially out of your control. You do have some control over it, but it's largely dependant on what others think about your website, unless you take an active role in off-page optimization. Off page optimization is quite a large topic, so I'll talk about it in a separate article.

Basic On-Page Elements You Need To Tweak:

For starters , you need to give your pages a title between the <> - < /title > tags in the head section of the page. Make it a descriptive title with at least 1 keyword. 4 words maximum is usually enough. Please don't leave the title as "untitled", and don't set it to "home" or "Page 1" or anything like that. Doing so won't help your search engine rankings one bit.

Next you need to write a description using the description meta tag i.e. < name= "Description" content= "yourdescriptionhere">. This should go in the head part of the html, after the <>

Now You need to use the keyword meta tag . Just as a side note, most search engines don't often use meta tags anymore, but it certainly wont hurt your rankings. Here's what the keyword meta tag looks like, < name= "Keywords" content= "your,keywords,here">. Include each keyword / keyphrase once. Do not repeat your keywords over and over in the keywords tag, once each is fine.

Ok now we need to change elements of the page than people will actually see. The stuff you just typed in will only be readable by search engine spiders when they crawl your pages, apart from the title of your page of course.

First you need to have a header in a
"tag." It doesn't look particularly pretty, but it's effective. It lets the search engine spider know, that the piece of test in the

tag is important. Now you need to write a header in the

that contains your keywords. It's pretty similar to just having the page title on the actual page. Doesn't need to be long, just a few descriptive words about what the following page is about.

This next one is the part I'm going to have to leave in your hands. If you haven't got any content on the page, then you need to write it. Try to include the keywords about 3 times in the top third of the page. Only put them where it will read correctly. For example don't put them all in one sentence because it will sound silly. Try to make your content an absolute minimum of about 400-500 words.

Do you have images on your webpage ? Then you need to give them "alt" tags. These are just incase a user cannot display or chooses to not display images for whatever reason. Instead, they will see whatever you place into your alt tag. Only put in your keyword as part of the alt tag if it is relevant. The alt tag should be descriptive to the image.

Make the above changes to your webpages and you should see a nice rise in your search engine ranks when they next index your site. It will definately pay off in the end. Best of luck!

About the Author: Stephen Warren is the creator of www.MakeAGreatSite.com. There you'll learn how to make a great site and turn it into a money making machine in no time. Your free to publish this article on any website, providing it is unedited and complete, t

01/12/06 - New Law Threatens Internet Communications - Disclaimer

01/12/06 - VITAMIN LAWYER UPDATE e-MEMO

On January 5th the US president signed another complex and confusing law that has a serious threat to Internet communications buried in it.

The law is The Violence Against Women and Justice Department Reorganization Act, and the relevant section is 113. It states:

"Whoever...utilizes any device or software that can be used to originate telecommunications or other types of communications that are transmitted, in whole or in part, by the Internet... without disclosing his identity and with intent to annoy, abuse, threaten, or harass any person...who receives the communications...shall be fined under title 18 or imprisoned not more than two years, or both."

It is my opinion that this restriction will most likely not stand up against constitutional scrutiny. There is law backing anonymous political statements, reviewed by Justice Thomas in '95 - http://straylight.law.cornell.edu/supct/html/93-986.ZC1.html

"After reviewing the weight of the historical evidence, it seems that the Framers understood the First Amendment to protect an author's right to express his thoughts on political candidates or issues in an anonymous fashion."

I'm sending this alert out so that people are aware of this new law and can more carefully express themselves. For example, if you were to post an anonymous comment about, say, some company CEO, you might want to include some sort of disclaimer, such as "This statement is being made to express my opinions and understanding of the truth in the matter; it is not intended to annoy, abuse, threaten, or harass any person."

I still don't understand why Congress doesn't get it -- the First Amendment states explicitly "Congress shall make no law..." abridging freedom of speech -- "no law" means just that: NO LAW.

Here is a cogent comment I received from a knowledgeable source:

“It turns out that the statute can only be used when prohibiting the speech would not violate the First Amendment. If speech is protected by the First Amendment, the statute is unconstitutional as applied and the indictment must be dismissed. An example of this is United States v. Popa, 187 F.3d 672 (D.C. Cir. 1999). In Popa, the defendant called the U.S. Attorney for D.C on the telephone several times, and each time would hurl insults at the U.S. Attorney without identifying himself. He was charged under 47 U.S.C. 223(a)(1)(C), and raised a First Amendment defense. Writing for a unanimous panel, Judge Ginsburg reversed the conviction: punishing the speech violated the Supreme Court's First Amendment test in United States v. O'Brien, 391 U.S. 367 (1968), he reasoned, such that the statute was unconstitutional as applied to those facts.”

01/09/06 - Allergy Labeling; Credit Card Compliance Letter; Biography

01/09/06 - VITAMIN LAWYER UPDATE e-MEMO

This is your periodic Vitamin Lawyer update memo, provided to my client base and others interested in dietary supplement matters. If you don't want to receive such occasional messages, please reply to this email with "remove" in the subject line.

This issue covers:

1. New FDA Allergy label rules
2. Media Release: New challenge from credit card processors
3. Vitamin Lawyer biography

Happy new year!!
Ralph Fucetola JD

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1. FDA Allergy Label Rule

The Food Allergen Consumer Protection Act went into effect 01/01/06. The Act is at: http://www.cfsan.fda.gov/~dms/alrgact.html

On 12/14/05 a Guidance was published at: http://www.cfsan.fda.gov/~dms/alrguid2.html

The new law requires disclosure on the label of any ingredient including a major food allergen: "The term `major food allergen' means any of the following: (1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans"

There is no exemption for dietary supplements.

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2. PR Web MEDIA RELEASE: Credit Card Processors Compliance Letters

January 9, 2006

On-line Lawyer Reports Internet Merchants May
Now Need Credit Card Website Compliance Letter

Newton, NJ: Ralph Fucetola, J.D., confirms reports that major credit card companies have recently demanded its dietary supplement and online pharmacy merchants obtain regulatory compliance letters from an attorney expert in the field.

Over the past two weeks, Counsel Fucetola has learned from certain clients who prefer to remain anonymous that MasterCard has been contacting merchant services and vendors with on line pharmacies and nutritional websites. The credit card company now appears to require merchants to provide a form letter from a qualified attorney stating that their websites comply with all government rules and regulations. Additionally, they must acknowledge an attorney will review the site annually to assure continued compliance.

Ralph Fucetola, a.k.a. as The Vitamin Lawyer (www.vitaminlawyer.com) has been retained by a number of merchants to review specific websites and provide the required documentation. As an attorney of 34 years, he has been reviewing web content for regulatory compliance for over a decade. He is available to consult on a retainer basis; rates are reasonable and due to Internet accessibility, clients can expect a timely response. Please contact him at ralph.fucetola@usa.net.

For general FDA compliance, the Vitamin Lawyer (www.vitaminlawyer.com) offers a service that allows the site to display the Vitamin Lawyer Oversight Compliance Seal.

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3. Biography: Ralph Fucetola JD received a B.A. with Distinction from Rutgers University, 1967 and a Juris Doctor (Doctorate in Law) from Rutgers Law School, 1971. He practiced law for 34 years, specializing in Nutrient and Alternative Health Law. Counsel Fucetola has been widely recognized as a leading attorney in the field, receiving numerous awards, including a Citation of Merit from the National Health Federation (www.thenhf.com) in 1979 and a Meritorious Service Award (from the institute for Health Research, www.inhere.org) for his role in the 1995 DHEA Cases on behalf of the Life Extension Foundation. Counsel Fucetola limits his consultancy to claims, advertising and label review, asset protection, and consulting with marketers, consumers, advocates and local attorneys regarding Health Care Freedom issues, petitions and litigation.

01/13/05 - Structure and Function Claims Review

01/13/05 - VITAMIN LAWYER UPDATE e-MEMO

Happy new year! It’s time for your annual Nutrient Claims check-up!

The FDA continues to increase enforcement of its regulation of Dietary Supplements. In a recent Warning Letter to one vitamin company, for example, it found that the following statements were “drug claims:” "Nature’s answer to prescription medication" and "Nature’s alternative to prescription medication." The FDA also cited phrases such as, “seems effective in . . . reducing depression . . . ." In another recent warning letter, the FDA complained against the phrase, “the number one remedy against obesity.”

In yet another warning letter, Neutraceutica was told that its claim, “possibility of cancer and other diseases may be eliminated in the first days of the use” was an unproven drug claim. This is one time when I find myself agreeing with the FDA.

Staying up to date with changes in the law is also important. For example, a little known clause in the Farm Security and Rural Investment Act amended the Food and Drug Act to provide that the term “ginseng” can be used only for derivatives of the genus Panax, not the genus Eleutherococcus (though both are commonly known as “ginseng”).

What changes have you made in your web site during the past year that may put you at risk? If you have added new claims, have you notified the FDA of the new structure and function claims?

Now’s the time (while I’m snowed in here in the hills of Sussex NJ) for us to catch up on these necessary aspects of your legal needs. Please give me a call at 973-300-1519 so we can discuss your needs. These issues can be critical – and expensive -- for your company, if not addressed in a timely manner. That’s why I’ve sent you this email to remind you it is time for your annual FDA/FTC compliance check-up.

Ralph Fucetola JD

PS – if you need help in creatively constructing structure and function claims, let me know. In the first example above, “the number one remedy against obesity” the company could have stated, “a leading supplement to support normal weight…” As always, clients on regular retainers are guaranteed no increase in fee rates and may qualify for the Vitamin Lawyer Oversight Seal (see www.vitaminlawyer.com for details).