On the topic of the FDA and regulation of dietary supplements, I am quoted as saying:

“The fear was a Democratic administration was going to be 180-degrees different…But the measures taken have not approached the sort of draconian response a lot of folks in the industry feared.  That’s not to say things didn’t tighten, they did.”

David Ettinger Food Law Expert

Also quoted is food law expert (and college chum) David Ettinger of Keller and Heckman in DC.

Unfortunately, the link requires a subscription, but a 30 day trial is available.  To read the full article, click here.

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Marketers of nutritional supplements often complain that they do not know what the FDA wants. Even after the agency sends a warning letter about misleading claims and advertising, its staff does not explain what would fall within the rules. That’s the reality; the FDA will tell you what’s wrong, not what’s right.

Through warning letters, the agency provides insight into how a marketer can fall afoul of the rules. Companies that examine why their competitors get chastised can apply the lessons to their Web sites, catalogs, labels and the like.  Washington attorney Ivan Wasserman looked at the 73 letters issued in 2009 (way, way up from 44 in 2008) and found that 72 related to claims on Web sites. Six involved claims made in metatags.

Lesson #1: The FDA is surfing the Web, checking not just product descriptions and benefits, but Googling for questionable SEO/SEM.

Wasserman’s list would rank the letters by claim problems in this order:

• Drug and disease claims: 72
• H1N1 virus claims: 37
• Other drug and disease claims: 20
• Heart disease and cardiovascular claims: 11
• Diabetes claims: 8
• Cold and flu claims (not H1N1): 8
• Cancer claims: 8

Lesson #2: The medical emergency that makes the most headlines gets the greatest scrutiny. In 2009, that was H1N1.

The FDA also sent 12 warnings letters related to claims made on labels and product labeling. Some of these may have echoed what was published on Web sites as manufacturers compounded their marketing errors.

Lesson#3: The FDA reads labels in the stores and on packages sent by mail. Adding an asterisked disclaimer to language on a label is no protection.

The FDA lived up to its announced commitment of greater enforcement and more scrutiny of the supplement industry. The agency could top the century mark in warning letters this year. Companies that have not recently reviewed their sites and labels would be wise to do so now before the mail carrier brings bad news.

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In a year when initial public offerings and acquisitions were almost unheard of, the supplement business saw many go public and get bought.  Only iPhone apps fared better, and not by much.

Meanwhile, the regulatory landscape tightened, but not as much as expected under a Democratic administration.  While both foods and drugs had their shares of scandals, supplement makers passed their early cGMP inspections and emerged unscathed.

Looking ahead to 2010 we envision many new challenges and opportunities for the supplement business.  In no particular order, here’s what to look for in the year ahead:

Sports supplements face stiffer regulation. Under several proposals currently being circulated in Congress, the Drug Enforcement Administration would be given increased powers to schedule substances that are chemically similar to or precursors of human growth hormone effectively banning them from use without a prescription.  Some sports supplement makers will need to reformulate their products or face enforcement action from DEA, an agency far more aggressive than the FDA supplement companies are used to.

CGMP regulations impact small supplement businesses. In June companies with 20 and fewer employees become subject to the FDA’s dietary supplement CGMP regulations.  Companies that rely on contract manufacturing will receive a rude awakening as they are subject to regulatory scrutiny they have never previously experienced.  Small supplement makers should begin to prepare themselves by implementing standard operating procedures to comply with the new cGMP rules.  Many will fail to do so and by year’s end fewer small supplement companies will be around to see 2011 as a result.

Investors get serious about supplements. Expect more merger and acquisition activity in 2010 with special emphasis on venture capital firms seeking new opportunities for profit in the supplement space.  Ingredient suppliers, contract manufacturers, marketers and retailers are all in play.

Regulators take aim at Internet supplement businesses. Armed with new rules and increased funding, regulators at the Federal Trade Commission, Food and Drug Administration and state attorneys general will step up their attack on supplements sold as drugs and deceptive and unfair sales practices.  The FTC endorsement rule will be used against bloggers and the companies that sponsor them.  Learn and follow the rules now or get caught violating them later.

By all accounts 2010 will be a great year to not just survive but thrive.  We hope to be there with you and look forward to your comments in the year ahead.

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Jin Hua Qing Gan Fang made in lab.

The rules are different here in the United States. Hyde Park Holistic Center in Cincinnati recently received a warning letter from the Food & Drug Administration that read like many others having to do with nutritional supplements and the H1N1 virus. In China, though, the same admonishment could not be heard.

First, the FDA’s message to Hyde Park, which operates the Web site drdahlman.com: “The FDA has determined that your website offers a product for sale that is intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus in people. This product has not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation. prevention, treatment, or cure of the H1N1 Flu Virus.”

The product in question is “4 Life Transfer Factor Plus Tri Factor,” which is sold in a password-protected store on the site. The product apparently supports immune system health or, as the FDA quotes Dr. Dahlman on one of his Web pages, “I firmly believe that use of this product will sufficiently upregulate your immune system and should be a primary part of your strategy to avoid the dangers of swine flu (H1N1 virus).”

It’s worth noting that Dr. Dahlman is not an M.D. His online biography says he is “a Chiropractic Physician with a degree in Nutrition, is Director of The Hyde Park Holistic Center in Cincinnati, Ohio and specializes in treatment of chronic health problems using nutritional, herbal and homeopathic therapies.”

If Dr. Dahlman were in China, he might have gotten praise rather than criticism. On Dec. 16, Chinese medical specialists said they had developed a Chinese herbal medication to treat H1N1. An article from the official Chinese news agency, Xinhua, quotes Wang Chen, president of Beijing’s Chaoyang Hospital, as saying the medication “can shorten patients’ fever period and improve their respiratory systems. Doctors have found no negative effects on patients who were treated in this way.”

The article adds that the herbal formula, called “Jin Hua Qing Gan Fang,” had been tested at 11 hospitals on 410 people who exhibited mild symptoms of H1N1. With success in treatment over a five-month period, the makers were seeking international patents.

The herbal medication is being positioned as a lower-cost alternative to Tamiflu, which WHO recommends for the treatment of H1N1.
Interestingly, the article quotes Cris Tunon, a senior officer at the WHO office in China, as saying that “WHO welcomes the clinical results.”

It’s unlikely the herbal medication would get the same greeting in the United States. The FDA has warned a number of companies with herbal products to stop making H1N1-related claims. Twice in 2009, the AHPA has advised against the use of dietary supplements to prevent or treat the flu. What happens when “Jin Hua” is marketed on American shores?

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The DEA’s actions are the equivalent of the carnival game, “Gopher Bash,” in which you take a soft, oversized mallet and bop gophers on the head when they emerge through holes in a playing surface. Even though you might strike all the gophers on the head, they keep popping up.

The DEA, FDA, nutritional supplement make, retailers and some athletes are all prisoners of this game. The DEA is trying to keep up with companies that synthesize new forms of steroids. In this instance, the agency declared off the shelves the following — Madol, boldione and 19-nor-4,9(10)-Androstadienedione. Because they are now considered anabolic steroids, retailers run the risk of arrest if they sell supplements containing those substances. Manufacturers and marketers have to find another way to market the substances, which may be available by prescription.

And as more substances make their way onto the DEA list, makers, distributors and stores will have to keep a close eye on what they should — and should not — be producing and stocking. And athletes have to watch what they keep on their shelves; they do not want to accidentally take a substance that was banned after they bought it.

Rather than notify the DEA of a problem substance, Travis Tygart, the head of the United States Anti-Doping Agency, said in a statement that, “We need a regulatory system capable of managing the magnitude of this problem, and that can stop those rogue supplement manufacturers who are meanwhile profiting.”

Who might that regulator be? The logical choice would be the federal  agency that oversees drugs and nutritional supplements. Whether the FDA wants the full responsibility is yet to be seen.

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As we have written before, makers of nutritional supplements should pay close attention to comments submitted to the FDA before February 2010. There will likely be advocates for warnings on all products that make a claim to support good health. The agency’s rules on search-based advertising for health products could encompass non-prescription items such as vitamins and muscle-building powders.

The ruckus in Washington on Nov. 12 and 13 stemmed from FDA warnings in March to drug makers that their search-based ads did not contain proper product warnings. Drug makers backed off their advertising, and the search-engine companies saw revenues plunge. Everyone hurried to Washington to ask the FDA for clarification.

Google presented a solution. It told the agency that sponsored links are now less transparent and relevant. Google then proposed a standard for product-claim sponsored links:

1. A headline that links to a product landing or home page.
2. A first line with the Web address for that page, followed by an information message.
3. A second line containing a safety warning that cannot be altered, followed by a link to a Web page with more details on the warning.

You can see sample Web pages by Google at Scribd. Other companies and public advocacy groups will likely have ideas on how to balance sales messages and product warnings. There may be software solutions such as pop-ups or Flash that could be integrated in order to present more information in an ad, but an elegant solution seems unlikely. Thus, the FDA could write rules that force makers and marketers of nutritional supplements to alter their sponsored links in ways they never wanted.

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Ever since receiving FDA notices about their advertising generated from Google and similar searches, drugmakers have toned down their language and sought clarity on what is allowed. The discussion has ramifications for makers of nutritional supplements, because they could be next to face agency scrutiny for every ad created in response to a search for acai, reseveratrol and the like.

On Nov. 12, drugmakers and search-engine advertising agencies participated in about 30 presentations before the FDA. The hearing room was so crowded that most people seeking an audience seat were turned away. Here are two media takes:

(Yahoo’s David) Zinman testified that this shift to generic ads that don’t mention a brand name has created “a world where users have less transparency” because the ads deprive searchers of critical information about the landing pages. (MediaPost)

“We don’t think companies should be responsible for policing the entire Internet for information about their products,” said Johnson & Johnson executive Elizabeth Forminard.  (Reuters)

The key word is transparency, but Yahoo’s Zinman has it backwards. The FDA’s criticism was based on a lack of transparency in the form of who could take the drugs and what warnings should consumers receive before they clicked on the link. The FDA sent the warning letters because there was not enough information in the search-generated ads.

Forminard should walk down to FTC offices and read the new rules on Web marketing that take effect on Dec. 1; J&J will be responsible for a significant portion of what is posted on the Internet about its products.

There is more testimony today (Nov. 13) and the FDA will continue listening through February 2010. Nutritional supplement makers should watch for when they get dragged into the discussion. We all know that some vitamins are contraindicated for some people; will that fact have to be disclosed in your Google ad?

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Should there be a language standard in Google ads for supplements? Drug marketers may adopt rules given the close scrutiny that the FDA is giving search-generated ads for pharmaceuticals. The Interactive Advertising Bureau is asking the feds to endorse the use of standard formats online for drugs.

Why? Because seemingly harmless statements are incurring the FDA’s wrath. Case in point: A search for the pain medication Fentora generated this sponsored message from its maker, Cephalon: “Learn about treating breakthrough pain in patients with cancer.”

Harmless, right? No, said the FDA. According to a MediaPost report, the FDA deemed “such ad copy was deficient because it implied that all cancer patients with breakthrough pain could use Fentora.” The agency also said that the “implication was misleading because the drug is only indicated for people who can already tolerate around-the-click opioid therapy.”

The FDA warned a host of the world’s largest drugmakers that they too were running misleading ads. Unsure of how to act, the companies cut back on search-generated ads, with volume falling by about half. Now, the IAB wants a set of clear rules so that the drugmakers can resume online advertising without getting into trouble.

Standards may also help marketers of nutritional supplements. While drugmakers have a higher standard for publishing warnings and limitations on their products (see any Cialis ad), makers and marketers of nutraceuticals operate at their peril in making claims for ingredients. And sponsored links on Google could be one place they find trouble.

For example, a search on antioxidant produced this language in a sponsored link:

Get Healthy w/Natural Antioxidants
One Year Money Back Guarantee!”

Similarly, a search on glucosamine chondritin produced this ad language:

Drink Joint Juice and Leap More.
The 30-Day Joint Health Challenge!

How would the FDA or FTC view these claims getting healthy or jumping higher if they were made for drugs? The supplement industry may want an answer before agencies go on the offensive.

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This warning letter attacks a purportedly novel type of hand sanitizer called SkinWear that claims to work for up to 8 hours without alcohol in order to prevent the transmission of H1N1 Flu Virus.

Andrew Weill is in the FDA and FTC cross-hairs for claims that “astragalus, a well-known immune-boosting herb that can help ward off colds and flu” is available in the Weill Immune Support Formula product.

Similar claims were found at the site for Mountain Meadow Herbs who offer Anti-Inflammatory, Herbal Respiratory, T&C Formula, Flu Season (now marketed as Winter-Immune Booster), Infa-Flu, Blood Pressure Formula (now marketed as Herbal CardioCare), ClarkRx, and other products that FDA claims violate the FD&C Act.

And then there’s P&G and its Vicks DayQuil Plus Vitamin C product.  Mixing OTC drugs and supplements has been a sure way to elicit a warning letter lately.  The latest products to come under scrutiny are Vicks DayQuil Plus Vitamin C and Vicks Nyquil Plus Vitamin C which FDA says are illegally marketed combinations of drug ingredients and a dietary ingredient.  To read the warning letter click here. But wait, there’s more!  FDA has issued a press release telling the world that P&G is “unlawfully marketing” medicines!  Very scary!  To read the release, click here.

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FDA Deputy Commissioner Joshua Sharfstein, M.D.

FDA Principal Deputy Commissioner Joshua M. Sharfstein, M.D. gave the keynote speech to the Council for Responsible Nutrition Conference. Dr. Sharfstein expressed a willingness to work with supplement industry members and received a warm welcome from industry members in return.

Sharfstein filled in at the last minute when Commissioner Margaret Hamburg, M.D. was called before the Senate Committee on Health, Labor, Education and Pensions to testify at a hearing entitled “Keeping America’s Families Safe: Reforming the Food Safety System.”

Dr. Sharfstein started off by noting that FDA products account for $.20 of every $1.00 spent by Americans.  As to supplements, he revealed that he (like me) suffers from lactose intolerance and supplements with lactase enzyme.

Beyond the pleasantries, Sharfstein focused his speech on regulatory concerns with specific types of products and what FDA is doing currently to address these concerns.  Sharfstein pointed specifically to FDA successes in addressing products promoted for treating H1N1 flu, adulterated muscle enhancers containing anabolic steroids, and male enhancement supplements containing erectile dysfunction drug analogues.

Sharfstein also addressed suggestions that one way regulate adulterated supplements is through the NDI process.  Under DSHEA, ingredients that were in the food supply prior to October of 1994 are grandfathered in, but those that were not and require new dietary ingredient (NDI) applications.  However, as Sharfstein noted, there is no FDA recognized list of grandfathered supplement ingredients at present, and also many supplement products often contain undeclared ingredients which makes an approach that depends upon examining labels fundamentally flawed.  As a result, Sharfstein declared that new ingredient premarket verification is a priority for FDA.  With these and other challenges Sharfstein expressed a sincere willingness to work with industry to improve FDA response and regulatory strategies.

Sharfstein did receive several probing questions including a challenge regarding the FDA’s handling of the recent Hydroxycut recall, something we at NutriSupLaw have previously questioned several times.  The questioner noted that Hydroxycut was recalled based upon just 23 reports of liver disease out of over 20 million units of Hydroxycut sold, and asked Sharfstein for a the scientific basis of the FDA’s action.  The questioner also noted that the panel that raised concerns with Hydroxycut failed to identify a specific ingredient in the product that caused the problems, and there are many products still on the market today that contain those same ingredients.

To his credit, Sharfstein did not simply “toe the party line” on this issue in his response.  Instead he observed “I am getting the sense that there is a lack of understanding in this room about why the FDA did this,” and he went on to suggest that FDA reevaluate the matter and hold a conference call with industry to discuss it further.

Let’s see if FDA comes through and works with industry on these efforts.

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