The Nutritional and Dietary Supplement Law Blog

The American Herbal Products Association (AHPA) has requested that FDA clarify its policy on products combining over-the-counter drugs and dietary supplement ingredients. To read the letter from AHPA to FDA, click here.

According to this article in Natural Products Insider, AHPA sent the inquiry following the launch of an “analgesic phytosterol supplement”, Bayer Aspirin with Heart Advantage, by Bayer Healthcare; the product combines 81 mg of aspirin and 400 mg of sterols, and carries both OTC drug and dietary supplement labeling and claims.

In its May 29 letter, AHPA cited two past warning letters from FDA issued to companies marketing OTC-supplement combination products without first filing new drug applications. AHPA also referenced this 2000 letter from FDA in which the agency “strongly” recommended companies not to market such products, given possible health and policy issues.

To read the AHPA press release on this, click here.

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Your editor, dietary supplement regulatory attorney Joel Rothman, and seasoned supplement industry regulatory consultant Vincent Annunziata, in cooperation with the law firm of Seiden, Alder, Matthewman & Bloch, P.A., have announced the formation of a new FDA regulatory consultancy for small to medium size dietary supplement companies, Nutritional Supplement Compliance Solutions, LLC and the launch of its website at nutricompliance.com.

“The challenges facing small to medium sized supplement firms are significant and growing,” said Joel Rothman, President of NutriCompliance. “New regulatory requirements for adverse event reporting (AER) and good manufacturing practices (GMP) are forcing supplement firms to take on new and greater responsibilities they may not have the resources internally to manage. NutriCompliance helps small to medium sized companies “bridge the gap” and meet the demands of today’s expanded regulatory environment.”

Annunziata is a supplement industry veteran whose regulatory experience includes work for industry giants like Life Extension Foundation and Jarrow Formulas. “NutriCompliance provides a platform for us to serve the needs of small to medium sized supplement companies to help solve their regulatory challenges,” said Annunziata. “Whether it is FDA compliance, FTC review, or any other regulatory issue, NutriCompliance has the experience and strength to assist its clients to successfully address these challenges.”

Based in Boca Raton, Florida, NutriCompliance serves nutritional and dietary supplement companies with vitamin, mineral, herbal, homeopathic, and proprietary blend products throughout the state and the nation. For more information on the services provided by NutriCompliance, please contact info@nutricompliance.com or call 561-416-0170.

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Your editor here at Nutrisuplaw.com and regulatory consultant Vincent Annunziata are quoted in a new article in ICIS Chemical Business on the new cGMP regulations for dietary supplement companies. To read the article, click here.

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In a press release on the FDA website here, FDA announced the recall of twelve dietary supplements made by Herbal Science International, Inc., a/k/a Jen-On Herbal Science. The products in question are alleged to be adulterated and contain ephedra, aristolochic acid or human placenta.

A review of the company’s website reveals that they offer a selection of Traditional Chinese Medicine (TCM) products. According to the FDA, the company is recalling the following products that contain ephedra:

Wu Yao Shun Qi San Qing Bi Tang (Nasal Cleanser) Zhong Fong Huo Luo Wan (Stroke Revito Formula) Xiao Qing Long Tang (Little Green Dragon) Ding Chuan Tang Xiao Xu Ming Tang Feng Shi Zhi Tong Wan (Joint Relief) Guo Min Bi Yan Wan Fang Feng Tong Sheng San

In addition, the company is also recalling two products containing aristolochic acid, a carcinogen and nephrotoxin found in certain plants and botanicals. The FDA cited risks of serious kidney damage or kidney failure, as well as an increased risk of kidney cancer, for the recall.

Finally, the recall includes a product sold as “Seng Jong Tzu Tong Tan” that the apparently contains human placenta. Placentophagy supplementation? That’s a new one for me.

The release notes that no illnesses have been reported to the company to date in connection with these products and the company has ceased distribution of all of these products. The press release contains a statement from Herbal Science that says the company “apologizes for any inconvenience and expresses its concerns for the health of consumers by conducting a voluntary recall action. Herbal Science International, Inc. promises to ensure quality and integrity of all its products and the company is working closely with the FDA in the recall process.”

Interestingly, the company website contains no reference to the recall. Moreover, as of this writing, all the products recalled are still listed for sale here.

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The FDA announced that U.S. Marshals seized more than $1,301,712 of dietary supplements from LG Sciences, LLC, of Brighton, Mich., because the products contain unapproved food additives and/or new dietary ingredients that violate the Food, Drug and Cosmetics Act.

The sports supplements, which are all labeled as dietary supplements, are marketed for use by body builders under the brand names “Methyl 1-D,” “Methyl 1-D XL,” and “Formadrol Extreme XL.”  As of today, all were still for sale on the company’s website here under the category “anabolics.”

One news report contained the following comment by attorney for LG Sciences Ronald Berry.

The FDA seizure, Berry says, “was merely a preliminary step in determining compliance with food regulations.”

In a statement released by the company, Berry wrote: “Although LG Sciences feels the temporary restraint of its product by the FDA is inappropriate, the company appreciates that the FDA wishes to protect the public.”

In my experience, seizure is never a “preliminary step.”  Rather, it tends to be much further along in the investigatory process, somewhere closer to indictment which is hardly preliminary.

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Former San Diego State and NFL running back Obafemi “Femi” Ayanbadejo has filed suit against Nevada sports supplement company ALR Industries claiming he tested positive for steroids last year because he took a supplement made by ALR.

The positive test result led to a four-game suspension and his release by the Arizona Cardinals and Chicago Bears. Ayanbadejo also alleges that the stigma of testing positive in January 2007 has helped keep him from getting back in the league.

The read the report on the lawsuit in SignOnSanDiego.com, click here. The case is captioned OBAFEMI AYANBADEJO VS. ALR INDUSTRIES INCORPORATED AND AZTEC NUTRIMART, Case Number: 37-2008-00079427-CU-NP-CTL. The complaint is not available on-line. If anyone obtains a copy, please contact us, we would love to see it.

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According to this report from the Carlisle, Pennsylvania newspaper The Sentinel, Boiling Springs High School Student Andrew Figueiredo was suspended from school for taking 3 dietary supplement pills at lunch in the cafeteria. South Middleton School District administrators took the position that Andrew was taking medication without authorization and suspended him for 10 days. Andrew plays soccer, and the school also suspended him for half the season.

It appears that the school district’s position is that when Andrew took the supplements he violated his responsibility, set forth in the Boiling Springs Student Handbook, not to use drugs or alcohol. This incurs a 10 day suspension, but the school is also supposed to make sure Andrew “receive[s] appropriate support and education about the use of drugs and alcohol; receive[s] support from school nurse, guidance counselors, and Student Assistance Team in dealing with these issues if necessary.”

Not surprisingly, Andrew’s parents are boiling mad (pardon the pun), and have appealed the suspension. Andrew even took a drug test to assuage concerns that the supplements he took were really steroids. And, of course, they have a lawyer.

One of the comments posted to The Sentinel article astutely observes that since dietary supplements are regulated as a food, not a drug, in order to be consistent the school board will need to ban the consumption of food during lunch.  Perhaps we can convince the school that the appropriate support and education about the use of dietary supplements should be to read this blog.

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The FDA has released new guidance for dietary supplement labeling pursuant to the Dietary Supplement and Nonprescription Drug Consumer Protection Act passed at the end of 2006.

The Act requires supplement companies to report serious adverse events (adverse event reports or AER) concerning their products to the FDA. The AER reporting requirement went into effect on December 22, 2007.

The draft guidance was just published in the Federal Register on January 2, 2008. The guidance is presented in question and answer format. To read the new guidance, click here.

We will be posting additional information regarding the new AER reporting requirements here so check back soon.

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Excellent article in Today’s New York Times entitled On a Remote Path to Cures about the Peruvian herbal remedy maca, its cultivation, and the marketing of maca as a natural herbal supplement.

The principal focus of the piece is Chris Kilham a/k/a “The Medicine Hunter” (pictured right), whose business is “to promote natural, plant-based medicines, to protect the natural environment, and to support indigenous cultures.” The article tells the story of the complex relationship between this traditional herbal “cure,” the indigenous people whose livelihoods depend upon it, and the western companies that profit from it.

Make sure to view the interactive multimedia presentation that complements the article in the Times.

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The Nutritional and Dietary Supplement Law Blog resource page on State Food and Drug Laws has been updated!  This resource contains links to pages on the internet where the state food and drug laws for 47 states can be found. Because certain elements of the regulation of food, drugs and dietary supplements are concurrent with the states, this resource is invaluable for those of you who encounter a state law question regarding dietary supplement regulation.  The page can be accessed from the sidebar, or simply click here.

Summer intern Jared Weiser did most of the work developing this resource, and we thank him for his dedication to this valuable project.  Thanks Jared!

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FDA held a 3 hour webcast last week detailing its industry guidance on the new CGMP regulations. The webcast has been archived. To view the webcast at your leisure click here.

FDA suggests using Internet Explorer to allow full navigation through the webcast.

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Best-selling author Kevin Trudeau has come under fire again for violating an injunction banning him from making infomercials that misrepresent the contents of his latest book entitled “The Weight Loss Cure ‘They’ Don’t Want You to Know About.” To read the FTC’s brief in support of contempt, click here.

If successful, this will be the second contempt order entered against Trudeau. Trudeau has had several run-ins with the FTC, as detailed in the case filings archived at the FTC website.

This latest Trudeau incident provides some insight into the intersection of supplement marketing practices and the first amendment. The FTC could not, consistent with the First Amendment, prevent Trudeau from writing about whatever he chose in his books. However, the FTC can, and has, enjoined Trudeau from making unfair and deceptive claims about what he writes in those books, including, as in this instance, claims that a weight loss plan is “easy” when it actually involves eating a 500 calorie starvation diet combined with daily injections of a prescription drug banned in the U.S.

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