Ric Hobby - VP Govt. & Industry Affairs, Herbalife Europe

Ric Hobby spoke at the CRN Conference last week on the state of international supplement regulation with a particular focus on European regulatory efforts.  Ric directed most of his talk on the work of the International Alliance of Dietary/Food Supplement Associations, of which CRN is a member.

The three European issues where IADSA has been most involved are:
* Maximum levels of vitamins and minerals
* Claims
* Botanicals
Ric referred to the “claims” issue as a “raving nightmare.”  The claims process requires review and approval for all claims by the European Foods Safety Authority.  Under the current process even “established” claims for supplements are being rejected by EFSA.

Ric also highlighted IADSA’s popular publications it produces and distributes including a very useful one entitled “The Scientific Substantiation of Health Claims” featured here.  You can download the guide by clicking on it.

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Blackburn and Greider

Three Americans won Nobel Prizes in physiology or medicine today for their research on telomeres, the endcaps of chromosomes that protect genetic material from being erased. Understanding how telomoeres work is enlightening scientists on aging and disease. Nutritional supplement companies should pay special attention to this research as it may relate to their products.

The scientists were: Elizabeth Blackburn, a professor of biology and physiology at the University of California, San Francisco; Carol Greider, a professor in the department of molecular biology and genetics at Johns Hopkins University School of Medicine in Baltimore; and Jack Szostak, a professor of genetics at Massachusetts General Hospital in Boston. They had worked separately and together to show that when parts of telomeres were missing, DNA would eventually become shorter and cut off when replicated. Shorter telomeres lead to slower cell division and thus premature aging, the scientists discovered.

What can a person do to support the health of their telomeres? Research conducted National Institute for Environmental Health Sciences in the Research Triangle Park suggests that multivitamin supplements represent a major source of micronutrients, which may affect telomere length by moderating oxidative stress and chronic inflammation. (Disclosure: My mother was a research scientist at NIH in the Research Triangle Park.)

In a paper published in June issue of the American Journal of Clinical Nutrition, Qun Xu and her colleagues reported that multivitamin use was associated with longer telomeres. This is the first research to produce those results. While supplement makers cannot make aging-related health claims, they should take note of what the world is recognizing today and how it might affect their business in coming years.

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Peter is Board Certified as an expert in International Law, and his practice involves advice and representation to persons and companies involved in the international supply chain,  such as  importers, exporters, customs brokers, and freight forwarders.  He strategically counsels companies to prevent or resolve difficulties with United States Government law enforcement and regulatory agencies, especially the United States Customs and Border Protection (CBP).

I am pleased that Peter has tapped into the power of blogging to help educate and inform clients and potential clients faced with legal issues in his firm’s sphere of expertise.  Make sure to check out “How to get off the FDA blacklist” by Jennifer Diaz reposted by permission below.  Congrats to Peter and his team!

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Canada.com reports

Chronic wasting disease, or CWD, is a fatal disease that spreads among species in the deer family and is similar to bovine spongiform encephalopathy or BSE, commonly referred to as mad cow disease.

The group sounding the alarm, Calgary-based Alliance for Public Wildlife, points to a collaborative study by CFIA, the University of Kentucky Medical Center, Colorado State University, and the U.S. Department of Agriculture just published in the Emerging Infectious Diseases Journal.  To read the study, click here.

Meanwhile, the CFIA has posted a cautious Q&A about CWD on its website here.  One question asks is “powdered antler velvet from animals that have been exposed to CWD safe for human consumption?”

According to Health Canada there are no studies available on the safety of tissues from deer and elk with CWD. In studies using mice experimentally infected with scrapie, another TSE, muscle and skin tissues were not found to be infectious at any detectable level. Similarly it is recognized that BSE is not transmitted by meat and skin.

However, we have to be very cautious in using these results to predict the safety of products from infected or exposed elk, since test results from one species do not necessarily apply to another. Velvet and other products or by-products from elk or deer known to be infected with CWD are not allowed to enter the human or animal food chain. Velvet is used as a medicinal alternative.

No indication yet on whether the CFIA’s concern will spill over into the US and become an issue for FDA or USDA.

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The European Food Safety Authority (EFSA)

Taurine and d-glucuronolactone occur as natural ingredients in food, and are normal human metabolites. They are also usually used at much higher levels and in combination with different ingredients in energy drinks. The new data confirmed a No Observed Adverse Effect Level (NOAEL) of 1,000mg per kilogram of bodyweight per day for both substances.  Read the press release here.

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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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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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Peter Quinter

• Recommended pre-shipment due diligence
• What importers and customs brokers need to know to timely and completely file entries
• How to overcome automatic detentions and the relationship between the CBP and the FDA for reviewing food and medical devices

The presenters include representatives from the FDA and expert compliance officers. Attendance is free for members of the Florida Customs Brokers and Forwarders Association, or just $45 for non-members. To download a registration form with more information, click here.

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Helpful links from the presentation include FDA’s PowerPoint presentation the proposed regulations here: http://www.cfsan.fda.gov/~lrd/fr030313.html and a side-by-side comparison between the proposed dietary supplement GMP’s and the food GMP’s here: http://www.cfsan.fda.gov/~dms/dscgmps3.html. Also, more information courtesy of CRN is here: http://www.crnusa.org/pdfs/GMP4way.pdf.

Moderator Lambert observed that GMP implementation will probably result in “trial runs” by FDA inspectors of large facilities to allow FDA to become comfortable with the new regulations and their application.

LeDoux emphasized that GMP implementation will impact foreign supplement and ingredient manufacturers because the regulations will will apply to foreign firms that produce products imported into the US. The new GMP regulations may also be copied by some foreign governments, including ones in Asia, looking to create their own standards. LeDoux also observed that GMP implementation will also allow US firms to operate on an even playing field with foreign firms in countries that already have GMP regulations in place.

On a side note, one attendee noted that the implementation of GMP regulations may prompt plaintiffs lawyers in products liability cases to use the GMP’s as a standard of care for manufacturers in personal injury litigation. Good point.

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Fellow supplement blogger Marc Ullman of Ullman, Shapiro & Ullman, posed the question to Eugene I. Lambert, Senior Counsel at Covington & Burling, whether FDA user fees, such as those paid by prescription drug manufacturers to increase the speed of review for new drug applications, could be used to provide FDA with more resources to increase inspections of food and dietary supplement ingredients at the border?

Lambert agreed that such an application of user fees may provide a benefit to food and dietary supplement manufacturers and marketers, and could provide the industry with a reason to once again consider whether user fees are a tool help accomplish industry goals that the current regulatory scheme fails to address.

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