Wednesday, January 28, 2009

01/28/09 - FDA Revving Up Regulatory Actions

0.  News  -  Continuing Regulatory Threats…
1.  2008 FDA Warning Letters - Analysis
2.  Identifying Target Markets for Your Brand

0. VL Blog News

Blog: http:// vitaminlawyerhealthfreedom .blogspot .com

vitaminlawyerhealthfreedom.blogspot .com/2009/01/so-is-codex-threat-to-dietary.html
Yes, Codex continues like a dark cloud on the horizon… and, even closer to home:

BREAKING NEWS! This message from the Natural Products Association (NPA)

FDA responding “…to a citizen petition filed on behalf of a pharmaceutical company… has determined  that products containing pyridoxamine, a form of vitamin B6… are not dietary supplements within… DSHEA… 201(ff)  and "may not be marketed as such." In a confusing twist, the agency goes on to clarify that although pyridoxamine is a dietary ingredient… FDA  has determined  by the petition that pyridoxamine is excluded under § 201(ff)(3) because:  pyridoxamine is authorized for investigation as a new drug for which substantial clinical investigations have been conducted and their existence made public; and there is no "independent, verifiable evidence" of prior marketing of pyridoxamine as a food or dietary supplement; this includes the… NNFA list of grandfathered ingredients.  …this development presents a number of problems, including the agency's interpretation of §301 (ll) of the FFDC Act (which prohibits the interstate shipment of certain foods to which an approved drug or a licensed biological product has been added)…”

This past November, I warned the industry about the “sleeper” danger in section 301(11); see:
vitaminlawyerhealthfreedom.blogspot .com/2008/11/emergency-fda-usda-attacking-foods.html

And this very important piece by Dr Laibow: "The Psychology and Physiology of Change" - healthfreedomusa .org/?p=1940

Please note: all URL links are “broken” so AOL and other providers will not treat this eMemo as “spam,” so please remove any spaces and add the www. prefix.”

1.  Analysis of FDA Warning Letters in 2008nutraingredients-usa .com/content/view/print/234091

FDA supplement warning letters: 2008 year in review
By Ivan Wasserman and Svetlana Walker, 27-Jan-2009

“The US Food and Drug Administration (FDA) issued over 40 warning letters to supplement marketers last year. An analysis by FDA legal specialists Ivan Wasserman and Svetlana Walker reveals that the agency’s focus was on cancer claims made on internet web sites. The oftentimes ‘fuzzy’ line between permissible and unlawful claims for dietary supplements makes it essential to stay apprised of FDA’s enforcement actions in order to successfully navigate the dietary supplement marketing waters without triggering regulatory scrutiny. … The agency sends Warning Letters to manufacturers or marketers to inform them of violations of FDA laws and regulations. FDA may observe violations during an inspection of manufacturing or other facilities. The agency can also review product labeling and, importantly, claims made on websites.

One area of focus for dietary supplements is the distinction between permissible ‘structure/function’ claims and unlawful ‘disease’ or ‘drug’ claims (i.e., claims that the product will treat, cure, or prevent a disease. …Unless the recipient is able to convince the agency that it was wrong about any of the alleged violations, failing to correct violations may lead to product seizures, injunctions, or other enforcement actions.

Our review identified 44 Warning Letters concerning dietary supplements issued by FDA in 2008. Some of the findings of our review are set out in the following chart, and discussed in more detail below.

‘Disease’ claims  44
Cancer claims  36
Heart disease/cardiovascular claims  10
Diabetes claims  6

Claims made on websites  -  41
Claims made in metatags  - 21
Claims made on labels  - 6
Claims made in ‘third party literature’ - 11
Claims concerning ‘FDA approval’ - 4…

Out of 44 warning letters issued to dietary supplement firms, 41 of them were issued as a result of FDA’s review of the firms’ websites. Only three letters were sent following facility inspections.

The amount of letters triggered by website reviews highlights the importance of diligence when it comes to creating website content. As a general rule, FDA can consider any statement or claim that appears on dietary supplement web pages to be a labeling claim for the product. This can include claims made in consumer testimonials and in third party literature excerpts that describe the health benefits of their dietary supplements.

In terms of product categories, in 2008 FDA overwhelmingly targeted dietary supplements that made any type of cancer claim. Out of the 44 Warning Letters, 36 addressed cancer claims, making cancer by far the number one ‘disease’ targeted by FDA. …

In addition, our review revealed that the agency is concerned with the use of metatags with ‘disease’ terms. Metatags are used by companies to cause search engines to identify their websites when certain search terms are used by consumers. …

Finally, approximately 25 percent of the 2008 Warning Letters addressed third party literature violations, albeit as a secondary focus. In the letters, FDA noted that the use of excerpts from scientific publications, or citations to scientific publications in the same context as the marketing of a dietary supplement, was problematic if the excerpt or citation involved disease treatment or prevention….”


2. Identifying Target Markets for Your Brand
Entireweb .com/newsletter/archive/2009/PRINT513.html

“Identifying target markets for your brand is critical because your customers are the future success and growth of your business. But who are your customers and how can you find more like them? …

Your target audience is made up of the people who love of your business and what it offers. They are not everyone who will come in contact with your business.

In order to find your target market, start by refining your target audiences…

- Who are your best customers?
- Which target segment makes up the bulk of your customers, supporters, or members?
- What do all these segments or individuals have in common?
- Can you find others like them?

Recognizing what your customers have in common can help you craft a marketing strategy to draw in more of the same people, thus building your target audience into a successful business. …

- What is their typical age?
- Are they primarily male or female?
- What level of education have they received?
- Do they have any special interests or hobbies?
- How much is their household income?

By combining demographic and psychographic information… you can begin building a mental profile of your core market. … The only way to develop marketing communications that resonate with your target audience is to become knowledgeable about their wants, needs, and motivations. So ask them. Set up a continuous feedback and communication loops between your customers and the company. Make two-way communications a part of your corporate culture. You might also consider designing a short survey and sending it to your current and prospective customers and see what kinds of offerings, messages, and services your business should be providing. … While most businesses have multiple target audiences, they should only have one core market in order to provide as much focus as possible.”

Your papers must be in order. Do you have your SOPs (Standard Operating Procedures)? Is your web site Site Use Statement up-to-date? Learn more at my web site, www. SiteUseStatement .com or on my SOP page, http:// tinyurl .com/2eu6yj – Is your Substantiation Notebook ready? Your papers need to be in order before the FDA inspection!

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

Friday, January 23, 2009

01/23/09 - Mood Foods and the Future of Nutraceuticals

0. News  - Health Freedom – Change for the Good?
1. Mood Foods – the Latest Trend in Functional Foods
2. The Future of Nutraceuticals

0. VL Blog News

Blog: http:// vitaminlawyerhealthfreedom .blogspot .com

Health Freedom is Our First Freedom
Health Freedom Made it to the TOP TEN on
HealthFreedomUSA .org/?p=1910
We went up against all the hot-button issues and persevered.

Please note: all URL links are “broken” so AOL and other providers will not treat this eMemo as “spam,” so please remove any spaces and add the www. prefix.”

1. Mood Foods – Functional Foods TrendNew report breaks down global mood foods market
By Lorraine Heller, 21-Jan-2009

“Mood foods are emerging as the latest niche in the functional foods market, and are expected to experience continued growth, according to a new market report.
“Mood-enhancing foods are those that contain ingredients said to uplift mood, boost mental health or improve cognitive function. Although the category is still in its development stages and lacks a standard definition, it is an area attracting significant interest from consumers around the world… in countries with a developed and distinct functional foods market – such as the United States – foods making mood, emotional and cognitive health claims are emerging as an increasingly important category. .. ‘..the mood foods market will continue to experience a robust growth rate… As food scientists and marketers strive to infuse new ideas and incorporate new benefits, the focus of the functional foods industry is widening beyond the traditionally offered physiological functional benefits. In this context, functional foods and beverages that stimulate mental and emotional wellness emerge as an interesting market niche.’
“The mood food market saw ‘significant activity’ after 2000, with the first actors in the market being companies that were prepared to invest in the commercialization of products containing innovative ingredients. Small and medium-sized firms that capitalized on traditional mood-enhancing foods and ingredients – such as chocolate, ice cream or tea – were also at the starting line… the market will ‘continue to experience healthy growth rates’, boosted by an aging population prepared to spend more on prevention rather than cures… As well as the growing and more active baby-boomer population, other drivers for the growth in the mood-food market include changing lifestyles, rising consumer expectations and increased innovation...”
nutraingredients-usa .com/Consumer-Trends/New-report-breaks-down-global-mood-foods-market/?c=gbrnO2ewSG1JubPkBv3SmQ%3D%3D

2. The Future of Nutraceuticals

Many in the Natural Foods industry are asking what the future holds with the new Federal administration. lists "A crack-down on imported drugs and dietary ingredients that contain undeclared spiked pharmaceuticals." as one of the possibilities.

nutraingredients-usa .com/Regulation/What-Obama-means-for-functional-foods-and-supplements-Part-I/?c=gbrnO2ewSG0Sw5U%2B7Y9%2BBQ%3D%3D

This may also include the category of “Nutraceutical.” The Wikipedia definition of Nutraceutical is:

"Nutraceutical, a portmanteau of nutrition and pharmaceutical, refers to extracts of foods claimed to have a medicinal effect on human health.... More rigorously, nutraceutical implies that the extract or food is demonstrated to have a physiological benefit or provide protection against a chronic disease..."

Certainly such substances can come within the AMA Ethics Code Opinion 3.04 rubric of "therapies that may benefit" rather than "treatment of disease" and therefore not restricted to physician prescription.

See: lifespirit .org/Alternative-Practices.htm

The legal status of Nutraceuticals remains ambiguous. If the substance is:

1. grandfathered under DSHEA, it can be sold as a Dietary Supplement (sold since June 1994).
2. FDA approved new dietary ingredient, it can also be sold as a DS.
3. subject to an OTC monograph, it must be sold as an OTC medicine.
4. an approved prescription drug it must be sold as a prescription drug.
5. an unapproved drug, it may not be sold in the US (but US citizens can import from overseas under FDA regulation for personal use only; 3 months supply at a time).
6. just be an ordinary food it would be importable under those rules (including "Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act…",

See: vitaminlawyerarchives.blogspot .com/2008/11/110808.html

The article also cites, "June 2009 is the effective date for the majority of the supplement industry for GMP compliance. Will FDA dramatically increase inspections, and will we see a true reform of
manufacturing quality as a result?"

Clearly, “change is in the air…” What change, remains to be seen.

Your papers must be in order. Do you have your SOPs (Standard Operating Procedures)? Is your web site Site Use Statement up-to-date? Learn more at my web site, www. SiteUseStatement .com or on my SOP page, http:// tinyurl .com/2eu6yj – Is your Substantiation Notebook ready? Your papers need to be in order before the FDA inspection!

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

Tuesday, January 6, 2009

01/06/09 - Trends for Nutrients for 2009

0. News  - Health Freedom Reaches Round Two!
1. Nutrient Trends for 2009 – Top Ten Trends

0. VL Blog News

Blog: http:// vitaminlawyerhealthfreedom .blogspot .com

Health Freedom reaches Round Two on
Click here www.
to Vote to Bring Health Freedom’s Perspective to the New Administration

Invitation from Gen. Stubblebine to support Health Freedom:

Health Freedom is Our First Freedom
www .healthfreedomusa .org/index.php?p=1733

Please note: all URL links are “broken” so AOL and other providers will not treat this eMemo as “spam.”

1. Nutrient Trends for 2009

www .nutraingredients-usa .com/Publications/Food-Beverage-Nutrition/NutraIngredients/Industry/A-Nutra-eye-on-2009/?c=gbrnO2ewSG0ZwRqSh95F1w%3D%3D

[I’m forwarding this article in full, since it is so full of useful information. Please read on to the Ten Top Trends at the end of the article! R]

A Nutra Eye on 2009
By Shane Starling, 23-Dec-2008

As we wind down the online printing presses here at NutraIngredients for 2008, it seems appropriate to cast our eyes forward and locate those trends that are likely to battle for the functional foods and supplements spotlight in the coming year.

The momentum of areas that have dominated in 2008 such as probiotics, omega-3s, superfruits and weight management remains strong and seem certain to continue registering fat blips on the commercial and consumer radar in 2009. The interest you, our readers, have shown in these topics confirms this fact.

Despite the ongoing frustration of scientific studies that ask of vitamins, minerals, antioxidants, herbs and other nutrients that which they were never meant to deliver – like curing cancer or treating severe depression – the year ahead looks promising for their use in an array of matrices from supplements to cosmeceuticals to functional foods and drinks.

Built to purpose

With the financial climate bringing closer scrutiny to business and personal budgets alike, there is an argument that sales of healthy foods and supplements may benefit because individuals place greater emphasis on maintaining wellness through dietary choices, rather than face often exorbitant costs in the medical system.

As Julian Mellentin, author, consultant and editor of monthly trade journal New Nutrition Business, observes in ‘10 Key trends in Food, Nutrition and Health 2009’: “The effect of a slowdown will be to reinforce the core nutrition business trends and sweep away the fads and the peripheral ideas.”

In countries where state health support is minimal, this is especially the case, and makes a lot of sense as it allows healthy foods to play the role they were designed for – maintaining wellness and preventing disease – rather than some kind of silver bullet fired out of a shoddy gun. It’s a suss strategy and one that can only make pumpkins of all concerned.

If price premiums can be kept low, a process that should be assisted by falling energy and transport costs after a couple of years of steep rises, then a greater percentage of the population is likely to take an interest in foods with a ‘healthy halo’.

The year promises to be very interesting in terms of the way the ‘health halo’ can be marketed, with crucial European nutrition and health claims legislation reaching fruition in early 2010 and the resolution of the GSK weight loss petition expected in the US. With hundreds of millions of dollars and euros hanging in the balance, industry awaits with baited breath.

Top trends: Digestive health

Of all the categories predicted to shine in 2009, most of the trendspotters place digestive health near the top of the pile.

The probiotics and prebiotics-dominated area had an impressive year, especially in North America where the Dannon’s probiotic spoonable and drinking yoghurts continued their remarkable ascent into the consciousness of mainstream America.

The probiotic market there has surged past €500m from virtually zilch less than five years ago.

Mellentin ranked digestive health as THE KEY TREND for 2009, just as he did in 2008, and he noted the importance of efficacy in their success, as well as its overlap into the area of immunity.

Probiotic products, along with energy drinks, probably stand-out, as products that have consumers, as Mellentin says, “feeling the benefit” very quickly.

“Digestive health is a wellness issue that affects everyone; it is more important to consumers than heart health or cholesterol-lowering or any other medicalised issue,” he wrote.

Fibre, fruit and fruit juice as a non-dairy medium, would also play key roles in the digestive health area this year, he noted.


There are some, Mellentin included, who feel there is more hype to the omega-3 boom than hard sales, but as the major marine-sourced, omega-3 trade group, GOED, states, the category is still in its relative infancy.

While breakthrough mainstream sales in omega-3 foods and beverages are as yet few and far between, product launches are flooding the market in many regions and companies are refining their marketing ploys to match increasing consumer knowledge.

But there have been high-profile product withdrawals causing some to question the strength of public interest, but this is hard to gauge as supplement sales remain buoyant, and even those that have mounted them, have admitted to mis-directed and executed marketing campaigns.

It will be an interesting year for omega-3, but with its well-documented brain, heart and other health benefits, it is hard to see the ingredient falling too far from the spotlight in 2009, especially as formulation improvements continue, thereby increasing the potential for high-dose functional foods, which may go a long way to improving their all-round saleability.

Weight management

Despite greater awareness of dietary pitfalls, endless government ‘improve your lifestyle’ campaigns, and a general shift from the mainstream food industry to healthier foods, ‘globesity’ remains a major problem in many countries, and so ingredients and foods that can offer assistance in this area have an instant appeal.

There is also a large market for the non-obese who seek to control their weight or even their body shape.

Most large ingredients companies have an offering or a whole suite of offerings in the area ranging from plant extracts, to protein forms to salt, fat and sugar replacers and all offering either calorie burning, fat burning or satiety benefits.

Plant-based solutions took a blow in 2008 when Unilever pulled the pin on its hoodia ambitions, but with obesity rates surging in the developing world – especially in China, India and many other parts of Asia – it’s an area that will consume the attention of many in this business in the year ahead.


Superfruits have won a place in the mainstream, with sales of prominent forms like cranberry, pomegranate, goji and acai doing well in many western markets, and usually at significant premiums.

With the novelty factor just about worn off, it seems superfruits, at least some of them, are here to stay, and they may kicked open the door for new form of ‘regular fruit’ marketing also.

“Ten years from now, if science can substantiate the many benefits now emerging, the term ‘superfruit’ may become redundant – and fruit, like dairy, may be a vehicle for delivering a wide array of health benefits to consumers,” wrote Mellentin.

We could go on, but it may be time for a probiotic juice drink. May your choices be fruitful in 2009.

Mellentin’s top 10 trends for 2009 are:

1. Digestive health
2. Feel the benefit
3. Weight management
4. Energy
5. Naturally healthy
6. Fruit: the future of functional foods
7. Kids’ nutrition
8. Snacking
9. Target the loyal niches
10. Packaging and premiumization

A Peaceful, Prosperous New Year to All!
Ralph Fucetola JD
www .vitaminlawyer .com
http:// vitaminlawyerarchives .blogspot .com