The anti-aging category is huge and here to stay; Boomers have made sure of that, at least for the next few decades. The problem with a market such as anti-aging is the overwhelming desire by consumers to stay young, much like the desire to get or stay thin in the diet category. This is the vulnerability seized upon by Boston Globe'sKay Lazar, who reports on the "buyer beware" nature of this market segment.

While admitting the early science on many anti-aging compounds and finished products is alluring to consumers, wild marketing, especially on the internet, makes too many leaps beyond what large-scale research on these products has or hasn't discovered on their safety and efficacy.

Sure, many anti-aging compounds are in early stages of research, perhaps with only some in vitro or even some in vivo animal trials in support of benefits, but human trials do not happen overnight, and anti-aging consumers are willing to try products based on such potential benefits. The problem, then, really comes down to marketing anti-aging products. Lazar takes the opportunity to criticize regulation of natural products, especially supplements, by calling them weak and blasting the use of overreaching claims. Again, this is similar to outcry against diet product marketing. Lazar suggests consumers aren't adequately protected from such marketing. I tend to agree that "Fountain of Youth" and "miraculous aging cure" have no reputable place in marketing for products that are scientifically backed in anyway. Companies should stick to the benefits or potential benefits revealed via scientific investigation.

That said, this problem doesn't require pre-market approval by FDA, but more claims policing by FTC and others, including industry and consumer watch groups. Then swift action is required against violating marketers. Lazar shows hints of wanting to impose the dug model on anti-aging supplements, a tired suggestion of a tactic that just won't work. Consumers have a right to try potentially beneficial products, provided they are safe. ON that note, I think if consumers want to be on the cutting edge of anti-aging and try the latest ingredients, they must accept some of the risk, as in the products may not work to the desired degree or at all.

Lazar was good to point out a couple anti-aging companies who've seemingly devoted significant scientific resources to investigating the safety and efficacy of their products. There definitely are products out there trying to go the scientific route, yet still not delay too much on getting to market. INSIDER constantly tracks the research on such products and keeps up to date on what's new in the category, from products to marketing.

The key to tilting the odds of success in your favor in any cutting edge market is to be informed, not to have your hand held.

You thought all the voting was over? Well, there is a vote in the Democratic party of the House of Representatives this week for various in-house positions. The big vote of note is the showdown between Democrats Henry Waxman (Calif.) and John Dingell (Mich.) for the head of the House Energy and Commerce Committee, which has broad oversight, including food and drug safety and public health (Health and Human Services). Dingell is the current chair, while Waxman has been the chair of the House Oversight and Government Reform Committee. Neither one has been very supportive of the natural products industry since DSHEA passed. In 2006, after the Democrats took over the majority and, thus, the committee chairs, Dingell said the Energy and Commerce committee would go after dietary supplement regulation and FDA drug safety procedures. Both Dingell and Waxman have worked together in the past to revisit DSHEA and make wholesale changes. With this in mind, it is hard to say which of these two men would be better for our industry, relative to the powers of the Energy and Commerce Committee. Perhaps there's a lesser of two evils, or maybe it's a lose-lose situation for natural products, namely dietary supplements. Time will tell. There is so much on the Congressional plate, there is a chance neither would get to fulfill their dream of turning back DSHEA.

"The Inside Scoop" welcomes guest blogger AHPA President Michael McGuffin, who is following up my little Obama post with a detailed look at the incoming administration:

It has now been over a week since the largest electorate in United States' history exercised their right to vote, and selected Barack Obama as our 44th president while increasing the Democratic party majority in both the U.S. Senate and in the House of Representatives. In the intervening days, I have been contacted by several of you to discuss what this election outcome might mean for the dietary supplement industry, and especially the herbal products trade.

I have heard concern expressed that control of both the executive and legislative branches by the Democrats will inevitably lead to some restrictions on the sales and marketing of dietary supplements. The sense is that this party is more likely to create new regulations generally, and that more restrictive laws for supplements may be desired by several well-placed Democrats who have long been critics of the Dietary Supplement Health and Education Act. Perhaps the most prominently placed of these is the senior Senator from Illinois, Richard Durbin. Senator Durbin holds the second-highest position in the Senate as the majority whip. He was the first Senator to endorse Barack Obama, and he served as a co-chair of Obama's election committee. He may well have some influence in identifying key positions in the new administration, including some that are important to our trade, such as Secretary of Health & Human Services and FDA Commissioner.

The industry and its trade associations must remain vigilant to protect against any legislative or executive actions that would in any way reduce consumer access to dietary supplements, or that would limit the broad range of health-promoting supplements that are available. Our attention should extend to legislative interest on food safety and importation issues, as these topics will continue to be important in the 111th Congress that will convene next January.

But this industry should also ask whether an Obama administration will present not only challenges but also opportunities. The issue of health care reform was identified early in the primary campaigns as a high priority for virtually every candidate. And as a candidate President-elect Obama stated on more than one occasion, the United States "does not have a health care system - we have a disease care system." This seems to imply that meaningful health care reform must extend beyond health insurance reform, and in fact, Obama's health care platform places significant emphasis on disease prevention and personal responsibility for health maintenance.

Surely there is a place for the best of our products in a reformed health care policy that stresses the value of prevention and responsibility. AHPA and others that represent the dietary supplement trade, along with such natural allies as practitioners of alternative medicine, will need to find a seat at the table to communicate to the incoming administration the health benefits and potential cost savings of incorporating well-researched and traditional herbal products into a new and innovative health care system in the United States.

I sincerely hope that our industry will balance our attention on both defending ourselves against unneeded and restrictive regulations and on working to realize the opportunities that may now be presented. Please feel free to contact me if you become aware of any challenges that may develop, or to share your ideas on how best to realize any emerging opportunities.

Sincerely,

Michael McGuffin

President, American Herbal Products Association

mmcguffin@ahpa.org

While uncertainties remain over many of Obama's actions upon becoming president on Jan. 20, 2009, experts seem clear about one aspect relative to FDA: von Eschenbach is out—he plans to tender his resignation before Obama takes office. Somewhat ironically, one of the troubles von Eschenbach was to solve at FDA was the lack of official and consistent leadership under the Bush administration. There is speculation FDA under Obama would focus on food safety: ""He thinks this is a fundamental role of government to ensure that people's food is safe and he has been concerned that we are not in a position to ensure that," said Neera Tanden, a senior campaign adviser" (source: AP).

Among the measures possible under Obama, industry fees for new FDA inspectors could get the acceptance it lacked under Bush, and a produce traceability program could see the light of day.

As for natural products, Obama has not hinted at any positions, but one would think the Democrat-led Congress, including Reps. Waxman and Dingle, might have an influence with the Democratic President, which could be trouble for our industry. However, a good deal of speculation will have to wait until Obama names the new agency head. The drug industry seems to be behind Janet Woodcock, current head of FDA's drug division. Others tout Steven Nissen, a cardiologist, and Joshua Sharfstein, Baltimore health commissioner. Sharfstein once worked for Rep. Waxman. Nissen has drug trial ties, but has raised many concerns over drug safety.

Despite the ominous possible selections for FDA chief, the agency under Obama would still suffer under-funding and likely focus more on food and drug safety, not dietary supplements. Still, signs are pointing to an air of strict consumer protection at FDA. That could affect natural products as the administration progresses.

One interesting rumor is the possibility the "F" be removed from FDA and given to USDA, which would regulate foods (dietary supplements?) via creation of a new food agency dedicated full-time to foods. (source: Washington Wire, WSJ)

This will be an interesting situation to monitor.

Big Pharma has long eyed the dietary supplement market as a market ripe with opportunity, but has never discovered a way to go beyond simply competing head-to-head, supplement to supplement, with pure natural products manufacturers. Enter Bayer aspirin combined with dietary supplement ingredients—Bayer Aspirin with Heart Advantage and Bayer Women's Low-Dose Aspirin + Calcium—a marriage of a safe and heralded OTC ingredient with well researched natural ingredients approved in some way by FDA for health claims.

This consolidation of non-prescription segments often separated in a pharmacy is innovative, if not risky from a regulatory prospective. Aspirin products must have a Drug Facts panel, while natural ingredients must have a Supplement Facts panel. Bayer's line of OTC-supplement fusions has both such panels. It also has health claims for its aspirin-phytosterols and aspirin-calcium based on the claims approved by FDA for foods and supplement containing certain amounts of those ingredients.

However, longtime natural products industry foe Rep. John Dingell (D-Mich.) took exception to the aspirin products, sending a letter to Bayer execs demanding scientific evidence to back the health claims used on the labels.

Given aspirin's long history of safe use as an OTC drug, and the similarly relative benign supplements calcium and phytosterols, it is amazing the Dingell finds time in all the crises that currently face our nation and Congress to take exception with one of hundreds of product claims that come into question each year. Of course Bayer is high profile and aspirin a household staple remedy, so the opportunity for a political crusade is ripe.

In warning letters sent to Bayer, FDA says its problem with Bayer's new aspirin products is in the claims, which it says don't strictly adhere to those approved for each calcium-osteoporosis and phytosterols-heart disease. For plant sterols, foods must contain .65 g/serving; for supplements the required amount rises to 1.7 g/serving (3.4 g/day). Bayer's Heart Advantage has .4 g/serving, a total of .8 g/day according to recommended dosing.

Similarly, the FDA requires a food or supplement product to contain .4 g calcium and a label to note that more than 2 g/day conveys no added benefits. In its warning letter to Bayer, FDA notes its Women's Low-Dose Aspirin + Calcium contains an undisclosed amount of calcium carbonate but a total 300 mg elemental calcium. Otherwise, Bayer's label statement on calcium and osteoporosis appears to include the requirements of the FDA approved claim (multiple risk factors, 2,000 g/day maximum benefit, etc.).

In addition, FDA seems to be uncomfortable with the combination of drug and supplement, noting the use of both Drug and Supplement Facts Panels on the products' packaging. It said the inclusion of aspirin and the use of drug claims render the entire product a drug. It said Bayer could market the supplement ingredients separately from aspirin, provided it ensures any claims used adhere to the FDA-approved health claims under 21 CFR 101.72 (calcium) and 21 CFR 101.83 (plant sterols).

FDA seems to be wary of drug-supplement combinations because it may falsely imply both the drug and the supplement ingredients involved have been approved via the agency's drug approval process. It has taken issue with such products in the past, although it has claimed it will take a case-by-case approach, rather than one of a blanket precedent. However, Dingell challenged Bayer on its launch of these products given the FDA's past disapproval of such combinations. He said Bayer should have sought pre-market approval for these products. He added his committee will continue to investigate Bayer on this matter despite the FDA actions.

Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research argued that "...the overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events." She further noted that while FDA allows caalcium-osteoporosis claims, the use of the phrase "fighting" osteoporosis would require additional approval. She said the heart product similarly oversteps approved claim language by stating an effect on cholesterol instead of just coronary heart disease.

In defense of such combo products, Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), said combination dietary supplement-OTC drug products have a useful and important role to play in integrated healthcare and wellness, although he didn't specifically address the issue of pre-market approval for such products. "Our hope is that FDA will assist companies attempting to maneuver the regulatory challenges of developing products that combine these ingredients and meet the labeling and formulation requirements of both drugs and dietary supplements, as required by the law."

Mister explained in 1994, FDA stated in the Federal Register: "FDA does not believe that it would be appropriate to preclude such claims [health claims and OTC drug labeling] under all circumstances. Such claims may be permissible if a firm can demonstrate that dual claims can be made in a manner that will neither misbrand the product nor create a safety problem’ (59 Fed. Reg. 395, 419, January 4, 1994)."

He noted that statement has never been revoked. "Since then, FDA has issued a few warning letters addressing specific combinations of supplement and OTC drug ingredients, but has never publicly reversed its view that combination products with dual labeling can be developed that would satisfy the agency’s appropriate concerns for safety," he said. "It would be unfortunate if overly formalistic interpretations of labeling regulations carried the day and kept these beneficial products from consumers."

In various public statements, Bayer has said it is reviewing the FDA warning letters, but it stands behind the marketing of these products. It contends there is adequate warning and advice on the packaging. Heart Advantage was launched earlier this year (I saw an ad for it last night on CBS), but the apirin-calcium product has been on the market since 2002.

At this time, I am still awaiting Bayer's response to my specific questions about this situation.

Food safety has jumped front and center in the minds of consumers and governments around the world. From adulteration (melamine et al.) to microbial contamination (salmonella et al.), food crises are dominating the global marketplace. Considering these numerous issues facing food ingredients, the U.S. Pharmacopeia (USP), the new home to the Food Chemicals Codex (FCC), brought together numerous food standards regulators from various regions of the world to define issues, opportunities and solutions for food trade.

Held yesterday, Oct. 15, the Food Ingredients Workshop featured experts from USP, FDA, Health Canada, the Chinese Center for Disease Control and Prevention, Japan Food Additives Association and other experts working in Europe, South America, Australia/New Zealand and the Middle East.

Overall, the experts discussed the state of food standards and regulations in their region/country, especially on food safety issues. Specific attention was given to food additive and GRAS issues, as well as emerging technologies such as nanotechnology.

In fact, one of the surprises of the workshop was FDA's presentation, given by Annette McCarthy, Ph.D., CFSAN, which provided some insight on the agency's view of nanotechnology in food, one of the first times this position has been made public, according to James Griffiths, Ph.D., VP of Food & Dietary Supplements for USP. While not a mind-blowing revelation, FDA's view on nanotechnology definitely gave some early indication of what to expect, as McCarthy reported several interesting FDA viewpoints:

• The safety of a compound does not automatically apply to a nanoscale version of the compound, as the nano size can generate novel properties and physical characteristics.
• Scientific data gaps prevent FDA from supporting GRAS status for nano-versions of previously designated GRAS substances.
• Nano-sized food ingredients fall out of compliance with regulations if their chemical attributes are changed from the approved version, the intended use changes, the nano-ingredient is no longer produced under GMPs, or the quantity of the nano-particle in food poses a risk to health.

At this point, FDA is handling such ingredients on a case-by-case basis. McCarthy acknowledged that industry has requested more guidance on nanotechnology, but while such guidance is under consideration, FDA has decided to update existing guidance for new submissions to include nano-based considerations. For instance, with Food Contact Notifications (FCNs), McCarthy highlighted regulation indicating any manufacturing change to produce nanoscale particles would be a considered a significant change, if the nanoscale particles were not part of the original FCN.

For its efforts, FDA has partnered with the Woodrow Wilson Institute to explore any potential issues with nanotech food ingredients and active packaging.

Beyond nanostuff, FDA highlighted its recently announced efforts to approach food safety in global manner, including opening up field offices in others countries, namely China. This Beyond Our Borders initiative also includes India, Jordan, Europe and Latin America.

As the workshop turned to presentation from the international community, the information was fast and technical, albeit relatively general in scope. Health Canada outlined its initiatives, including research, on food chemicals, indicating a specific recent focus on toxins. The agency has plans to develop standards for selected natural toxins and create a Natural Toxins Reference Centre.

Europe has been a model for food-related standards, but it still faces some challenges in harmonizing efforts amongst European Union (EU) countries. The EU defines food or foodstuffs as any substance intended for ingestion, except medicinal products. Hmm, still a gray area there? While the EU seeks "free movement of safe and wholesome food" and has accomplished regulations for many nutrients, novel foods and health claims, its food safety association (EFSA) is still tackling newer issues such as allergens, nanotechnology and GMOs.

South of our own border, Mexico has a well-defined and organized food regulation system, centered on its COFEPRIS, its Federal Commission for the Protection against Sanitary Risk. In Mexico regulation, food, functional foods, nutraceuticals, dietary supplements and drugs are closely related. Among its current issues/priorities, COFEPRIS looks to define and classify food categories—herbal products, dietary supplements, etc.—address food safety issues, such as allergens, labeling and contaminants/adulterants, and address new technologies, including functional foods, GMOs and nanotechnologies. See a theme yet?

Way south of our border, the South Americans are banding together to form a trade bloc for free movement of goods between its member countries. Who knew of this Mercosur trade bloc? Full members currently include Argentina, Brazil, Paraguay and Uraguay, although Venezuela is knocking on the door. Chile, Peru, Bolivia, Columbia and Ecuador are non-active participants with no voting power, but could become members in the future if things work out.

In its drive for South American harmonization of food standards, Mercosur has taken a similar approach to many other global regions in turning to established standards for guidance. This includes Codex Alimentarius, EU Directive, U.S. FDA regulations and other South American and foreign regulations. The Mercosur regulations take a while to get approved, but thus far, there has been work done on labeling, food additives, processing aids, contaminants, pesticides and packaging materials.

While Mercosur was influenced by outside regulations and standards, their system is their own creation, and outside companies tackling this system need to mind Mercosur regs as well as the regs in each individual country in Mercosur. You're best bet? Speak Spanish and/or retain experts in each country, and filed all your petitions at the same in all the countries plus Mercosur itself. Sounds complex.

The Australia-New Zealand efforts at food standards also took direction from the EU, FDA, Codex and FAO/WHO JEFCA. However, food sector expert Simon Brooke-Taylor said it was important to determine what worked and didn’t' work for the Trans-Tasman initiative.

The food safety agency in Australia and New Zealand (FSANZ) developed the standards and provides advice on them, but the Ministerial Council sets policy and approves or rejects standards. Put simply, in this region, food must be safe and suitable, and must comply with a regulation where one exists. For food additives, processing aids, nutritive substances (including vitamins), novel foods, GMOs irradiated foods and labeling, there are regulations in palce. The more detailed review of food regulation shows current issues, such as how to deal with functional additives, new foods and technologies (nanotechnology), synthetic food colors, and surprise issues such as contamination and adulteration.

Its biggest effort appears to be in the area of allergens, including allegen labeling. Its Voluntary Incidental Trace Allergen Labelling (VITAL) initiative and its recently created (2005) Allergen Bureau are proof of the heavy attention Australia and New Zealand are paying to allergens in food.

North of this region is China and its areas of political control/influence. Junshi Chen, M.D., from the Institute of Nutrition and Food Safety, Chinese Disease Control and Prevention, braved his countries recent image and reputation problems and presentated his take on food regulation in China. Among the positives, he said China food regs and standards are fine, noting they are basically in compliance with international practices, including the Codex General Standard for Food Additives (GFSA). However, he admitted China has a lack of specification for almost half of the food additives approved for use, few specs for flavors and a positive list for packaging materials that hasn't been updated in more than 10 years.

On China's recent food safety crises, he insisted the adulteration cases "are not due to the illegal use of food additives, colors or processing aids. The problem is with bad companies in a system where the number of companies involved in the food trade far overwhelm the ability of the Chinese government to police and inspect. He further said, despite melamine problems, chemical hazards are not the number one food safety problem in China, but microbial hazard/contamination is at the forefront. He said risk analysis is the only efficient way to deal with any type of food safety issue.

One of the most interesting—and entertaining presentation was on the Middle East. Though not from the Middle East, P. Vincent hagerty, Ph.D., a consultant to WHO, FAO, USAID, EU and Dubai, has worked in middle east to help set up food standards and agencies, most recently in Egypt. He said flat-out that this region is far behind the western world and Asia, and has many obstacles to overcome before it can properly oversee food regulations and standards, especially food safety issues.

While Gulf Cooperation Countries—Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and United Arab Emirates (UAE)—got a more positive nod for progress on food trade and safety, Hagerty, called the efforts by Middle Eastern countries, for the most part, ineffective, inefficient, fragmented, outdated and inept. He expressed particular concern in Egypt, where he said those in charge of food regulation and oversight are more concerned with handouts or bribes than with establishing regulations to protect their citizens, culture and tourism income. He said the organizational structures of many of these countries are complex and weakly coordinated, and many don't see the value in treating all food the same, whether imported, exported or locally produced. He did say efforts such as USAID's in Egypt and elsewhere are making a difference, albeit slowly, but said one major barrier has been language; Arabic offers little , if any, vocabulary to describe new scientific and technical terms, especially nanotechnology.

Despite all these flaws, some countries in the Middle East are getting some aspects of food regulation correct, although there is a tendency for some countries to simply cut and past EU, FA or Codex standards, instead of creating standards that reflect the people, culture and other needs of its populations. Hagerty said the opportunity in this region is huge, as the countries generally have the income and desire for functional foods, dietary supplements and even new technologies.

All in all, there was too much to take in during this day-long workshop. Thankfully I have a handy workbook to review and tons of new contacts around the world for any upcoming stories on food safety or regulation. If you are interested in learning more about the workshop and its participants, contact the USP at (301) 881-0666 or visit USP.org for more information.

After the NY Daily News posted an item on presidential candidate John McCain's possible use of an herbal memory enhancer before last night's debate, the blogosphere lit up with the news and some interesting short analysis. Rumor is McCain took some Neuro1, a formulation of 18 "neuroutrients" touted to improve focus, confidence memory and overall brain health. Who is the maker of this supplement? Nutrition 53, founded by former NFL bad boy Bill Romanowski. Many have drawn humorous connections between Romanowski's roid rage behavior on and off the football field with McCain's legendary short-temper.

Nutrition 53 would not confirm the Senator took Neuro1 before the debate, but McCain's campaign reportedly confirmed it secured a memory enhancing herbal supplement. I don't profess to know Nutrition 53 too well, but I acknowledge the irony relative to rage and temper. Of course, I applaud the Senator and presidential candidate for seeking a natural approach to brain health, but I wonder if he is aware of all the high quality, long-time providers of researched brain health supplements in the natural products industry. I'm sure a few such companies would have offered up some samples for him to try. My other question is, did the supplement work? My guess is, quality aside, he took them as an acute measure instead of a more long term solution to cognitive function.

Check out our recent cognitive function article for more information on scientifically researched natural remedies in this area.