Welcome to our May edition of the Update eMemo.
First, I reprint a brief announcement from NPA on the first of the FDA’s new regulations under the Food Control Act – remember, Dietary Supplements are considered foods.
This Edition: New FDA Regs; Quotes from Supply Side East; Warnings for Natural Product Companies (and a "Comfort Letter" offer); Archived Webinars; Natural/Nutritional Clinical Trials.
FDA Issues First New Regs Under FSMA - by Mary Rothschild | May 05, 2011
The U.S. Food and Drug Administration announced two new regulations Wednesday, the first rules issued since the Food Safety Modernization Act gave it some extra muscle. Both rules take effect July 3, the agency said in a statement.
The first rule allows the FDA to detain food that may be contaminated or mislabeled. The agency will have 30 days to keep potentially unsafe food from entering commerce while it determines whether further action - such as seizure or a federal injunction - is necessary. Previously, the FDA could act only if there was evidence of serious harm or threat of death, and had to work under states' legal authority in negotiating recalls with food companies. FDA said it will continue to work in partnership with state agencies, but now has the power to administratively embargo…
The second rule requires anyone who imports food or animal feed into the United States to disclose whether another country has already rejected or refused entry to the same product.
Quotes from Presenters at Supply Side East, earlier this month.
RESVERATROL IS HOT! “New food and beverage product launches containing resveratrol tripled in 2009-2010. This is an ingredient to watch…” Tom Verhile, Datamonitor
AND SO IS PROTEIN! “Almost half (49 percent) of adults in a 2010 IFIC survey said they were trying to eat more protein. I think this is going to be a real breakout area as products move from the sport nutrition area to the mass market.” Tom Verhile, Datamonitor
BUT HIGH FRUCTOSE CORN SYRUP IS NOT “More than 2% of all new food product launches in the US in 2010 contained the claim ‘no high fructose corn syrup’ compared with 0.2% in 2006…” Tom Verhile, Datamonitor
CONSUMERS DON'T UNDERSTAND FAT "In the IFIC 2010 consumer survey, 43 percent say they are trying to eat more omega-3s, but 37% say they are trying to consume fewer polyunsaturated fatty acids [which would actually include omega-3s] and 31 percent are trying to consume fewer monounsaturated fats [healthier fats such as olive oil]." Tom Verhile, Datamonitor
KEEP IT SIMPLE, STUPID “I think we’ll see more functional food products with single ingredients instead of ones with multiple ingredients and claims where manufacturers have thrown in the kitchen sink.” Mark Crowell, CuliNex
A NATURAL HIGH? “There has been an increase in foods fortified with vitamins and minerals, but a much bigger interest in foods claiming to be ‘naturally high' in them.” Bob McNabb, Natural Marketing Institute
CONSUMERS EQUATE ORGANICS WITH HEALTHIER “Surveys asking why consumers first started buying organics show that 54 percent did so ‘to promote health’; 40 percent said it was to 'help the local community' and 34 percent say to 'help the environment'.” Bob McNabb, Natural Marketing Institute.
FOOD SAFETY DOUBLE WHAMMY? “If you’re a supplier of raw materials to the dietary supplements industry your customers may already expect you to follow GMPs, but under the new Food Safety Modernization Act (FSMA) you will also be required by law to follow FSMA's new HACCP rules, so there could be some duplication of efforts.” Marc Ullman, Ullman, Shapiro & Ullman
ALWAYS READ THE SMALL PRINT “Qualifying information about claims must be clearly and prominently disclosed on your label near the claim itself. Putting qualifiers in mouse type doesn’t quite cut it.” Steven Weisman, Innovative Science Solutions
Warnings for Natural Product Companies!
Several clients are raising funds to invest in Clinical Trials or Clinical Studies; I was asked to prepare a “Comfort Letter” for the clients to use with their potential investors. If you would like a copy addressed to your Company, to raise the funds you need to invest to stay in the market, please email me!
The Red Letter warnings I sent you in recent weeks from the NPA & ASA urgently restate what I’ve been telling my perceptive clients regarding the vitamin or natural products companies. Are you ready for the FDA inspectors? I told you the 4 essential steps you must take in the last issue of the VL Update. Here, I add estimates of what these essential steps will cost your company. You need to budget now and start to do what you can to be prepared.
HHS Secretary Sibelius admitted a couple days ago that she has a $16 Billion slush fund under Obamacare that can be used to fund activities like the FDA’s 4,000 new inspectors… and FDA has already dramatically increased inspections, without those new bureaucrats!
What do you need to survive an FDA inspection? I’ve told you several times!
- Standard Operating Procedures – in place and up-to-date -from $500. The SOP document not only satisfies FDA, but also helps you organize your business!
- Product Substantiation Notebook – in place and up-to-date –from $500 plus your research time; this Notebook is a MUST if you get inspected! Part of the Notebook includes copies of the Structure and Function Claims Notices companies are required to file with the FDA within 30 days of marketing any claim. The cost for these notices is from $340.
- Copy-writers who know how to avoid Red Flag claims & Illegal Testimonials! My webinar on these issues is inexpensive. $99 for the archived CAM Webinar; a private copywriter webinar just for your company copywriters will cost above $500 (the webinar includes an eBook specially written for your company).
- A Third-Party Clinical Trial of your product; you can no longer fully rely on published science about isolated ingredients – This can cost up to several hundred thousand dollars. NCT offers a Minimal Clinical Trial from $35,000.
the more at-risk is your company!
Archived Cautions for CAM Wellness Practices
"Do you have a CAM “Alternative” health practice? Do you provide nutrients, remedies or health related items to clients?
Do you have questions about your legal rights and limits … or need information about how best to run your health care business? Are you aware there are words you cannot use and statements, although true, you cannot safely say to clients?
Hiring an attorney, one on one, to review these issues could cost you hundreds of dollars… making a mistake could cost you thousands. I invite you, instead, to learn from my Webinar, Cautions for CAM Wellness Practices.
I am known as The Vitamin Lawyer, because much of my 36 year legal practice centered around helping people in CAM practices, nutrient purveyors and advanced healthcare teachers. Today I am a Trustee of Natural Solutions Foundation. I can keep you out of trouble and operating smoothly so you can fulfill your mission to help others…"
This $99 PEL Webinar runs about an hour through 32 slides. It includes an 18 page eBook of information and forms all of which would cost over $500 if one on one. This is a Natural Solutions Foundation Benefit Webinar."
NCT Clinical Trials Center
The Natural Solutions Center in Volcan, Panama is now open, so Clinical Trials are beginning shortly! GET YOURS SCHEDULED NOW. The cost of a basic 12-person, one month Clinical Trial with a formal Report signed-off by credentialed professionals is about $35,000.
Prof. Udani on Clinical Trials - If you haven't seen it before, I urge you to watch the short video from Prof. Udani, who says that you need to get your Clinical Trials done if you want to remain in business! See his video here:
Meet Drs. Laibow and Goodman.
• To demonstrate product safety
• To substantiate product claims
• To determine "typical results" for Testimonial Ads
• To meet batch testing requirements
• These changes also mean you must not -
• Make claims you cannot substantiate
• Use Testimonials without disclosing "typical results"
• What can you do to tell your customers that your product is helpful, effective and important for them to use? Let us show you what we can do to help you with cost-effective clinical work...
Natural Solutions Wellness Center has established the Natural Clinical Trials Program - the NCT - to bring our special expertise to natural product clinical studies, tests and trials.
The NCT Program is headed by Dr. Rima E. Laibow MD, with the collaboration of Dr. Robert Goodman PhD, Ralph Fucetola JD, and the Natural Solutions Center Staff.
“In my opinion, over the next two to three years a company that still wants to be on the market and on the shelves needs to start investing in clinical trials today,” said Dr Udani.
Vitamin Lawyer Connections…
Notice of Fee Increase:
New rates: $340 standard and $285 discounted.
Do you Skype? If so, free Skype.com is one of the easiest ways to contact me, no matter where I may be.
My Skype handle is: vitaminlawyer
Our new affiliation site: www.naturalhealthoptions.net
Do you have an affiliation program? We’d like to list it.
If you don’t have an affiliate program… I have Affiliate Program SOPs & Rules …
And good advice… for you.
“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www.youtube.com/watch?v=wWPvzpn0YgA www.powerpicturesinc.net/store.html
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Ralph Fucetola JD
www.NaturalHealthOptions.net www.vitaminlawyer.com http://vitaminlawyerarchives.blogspot.com http://vitaminlawyerhealthfreedom.blogspot.com www.HealthFreedomPortal.org
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