A recent European study found patients using homeopathic remedies over an eight year period showed substantial improvements in their physical and mental health.

The multicenter, cohort study looked at 3,709 patients from 103 homeopathic primary care practices in Germany and Switzerland.  Improvements in conditions such as headache and allergic rhinitis in adults and atopic dermatitis and infections in children were common, but more significant in younger patients, females, and those with the greatest disease severity at baseline.

The authors did note that patients were allowed to use conventional and other complementary therapies during the course of the study and that the observed improvements cannot be attributed to homeopathic treatment alone.

BMC Public Health. 2008 Dec 17;8(1):413. To read the abstract and obtain the full text, click here.

The Food and Drug Administration issued a warning letter to The Coca-Cola Company, objecting to the labeling of their Diet Coke Plus product which describes the drink as “Diet Coke with Vitamins and Minerals.”

Regulators said the beverage does not have enough nutrients to justify the use of the word “plus” in its name. According to the agency, foods labeled “plus” must have at least 10 percent more nutrients than comparable products. Additionally, the FDA said it is inappropriate to add extra nutrients to “snack foods such as carbonated beverages.” To read the complete warning letter click here

Although Section 403(y) of the Federal Food, Drug, and Cosmetic Act (FFD&C Act) (21 U.S.C. 343(y), does not require a dietary supplement label to include anything other than a domestic address or phone number for the responsible person, the FDA recommends that the label also bear a clear, prominent statement informing consumers that the domestic address or phone number is for reporting serious adverse events associated with use of the product.

Under section 3(d)(2) of the Dietary Supplement and Nonprescription Drug Consumer Protection Act, the labeling requirements of section 403(y) ofthe FFD&C Act apply to all dietary supplements labeled on or after December 22, 2007. Therefore, these labeling requirements are already in effect. However, FDA intends to exercise enforcement discretion for the new labeling requirements until January 1, 2010.

FDA would have no objection to a firm’s combining the recommended statement with language informing consumers that the domestic address or phone number on the label may also be used for other purposes, as long as the information provided is not false or misleading. For example, a dual-purpose label statement might be “To report a serious adverse event or obtain product information, contact. .. ” or other similar language.

The National Advertising Division (NAD) of the Council of Better Business Bureaus has recommended that General Mills modify or discontinue certain advertising claims for the company’s Yoplait Yo-Plus product.

NAD, the advertising industry’s self-regulatory forum, examined broadcast, print and Internet advertising for Yoplait Yo-Plus, following a challenge by Dannon, the maker of Activia Yogurt, a competing product.

To read the press release, click here

A Utah-based operation that lured online customers with free samples of a purported weight-loss supplement in a scheme to obtain their credit or debit card information has agreed to pay $150,000 to settle Federal Trade Commission charges of deceptive and unfair marketing, and of violations of federal regulations governing the electronic transfer of funds.

According to the FTC’s complaint, the defendants, operating through their umbrella company Ultralife Fitness, Inc., lured customers by promising to send, for a specified trial period, free samples of the dietary supplement Hoodia, which they claimed caused weight loss. The supplement was purportedly derived from the cactus-like Hoodia gordonii plant, which is found in southern Africa.

To read the press release, click here

The Federal Trade Commission announced it has approved publication of a Federal Register notice seeking public comments on proposed revisions to the Guides Concerning the Use of Endorsements and Testimonials in Advertising.

In a Federal Register notice published in January 2007, the FTC sought public comment on the overall costs, benefits, and regulatory and economic impact of the Guides, which were last updated in 1980. In the newly approved Federal Register notice, the FTC’s proposed revisions to the Guides address consumer endorsements, expert endorsements, endorsement by organizations, and disclosure of material connections between advertisers and endorsers. On the issue of consumer endorsements, the proposed revisions state that testimonials that do not describe typical consumer experiences should be accompanied by clear and conspicuous disclosure of the results consumers can generally expect to achieve from the advertised product or program.

To read the press release, click here

The FTC announced 11 law enforcement actions challenging deceptive advertising of bogus cancer cures. The FTC charged the companies with making unsupported claims that their products cured or treated one or more types of cancer. In each case, the company is charged with violating the FTC Act, which bars deceptive claims. Some complaints allege that the companies also falsely touted clinical or scientific proof for their products.

The FTC also announced a new Web site about bogus cancer cures. The site – www.ftc.gov/curious – tells consumers how to spot and report bogus claims they see online, and urges people with cancer to talk to their treatment team about any products they’d like to try.
The site features a video and includes a list of resources on cancer treatments from a variety of agencies within the federal government. Information is provided in English and Spanish.

The cases announced today began through an Internet surf conducted by the FTC, the U.S. Food and Drug Administration (FDA), and Competition Bureau Canada in June 2007. Following the surf, the FTC sent warning letters via e-mail to 112 Web sites between August 2007 and January 2008. Of these, nearly 30 percent either closed their sites or removed the problematic cancer treatment claims. The remainder were reviewed to determine whether a law enforcement action was warranted or whether they should be referred to the FDA or the Competition Bureau.

To read the press release, click here.

CFSAN issued this press release recently that announces the publication in the Federal Register of a notice (73 FR 43937; July 29, 2008) requesting comment on Section 912 of the Food and Drug Administration Amendments Act of 2007 (FDAAA).

Here is FDA’s summary of this new provision:

Section 912 of FDAAA prohibits the interstate shipment of certain foods to which an approved drug or a licensed biological product has been added. Section 301(ll) also prohibits the interstate shipment of foods containing an added drug or a biological product that has been the subject of substantial clinical investigations, the existence of which has been made public. Foods that may be affected by the provisions of section 301(ll) include human food, including infant formula, medical foods, and dietary supplements, and their ingredients; food contact substances, including most food packaging; and animal feed, including pet food and feed ingredients. We are seeking comments about the impact of section 301(ll) on food in all its forms, including food ingredients, categories of food, and finished food products.

The text of the statute is set out in the FR notice cited above.

Section 912 is very puzzling. It seems to be focused on regulating foods/supplements that contain drugs/biologicals. However, the FR notice says that there was no legislative history of this provision at all.

The total lack of information as to why Congress passed this is a concern. It is not apparent what this was supposed to deal with or why this was enacted. It appears that FDA is scratching its head on this as well.

The only thing I can think of as an example of a practice that this would target would be putting sildenafil or its analogues in “male enhancement” supplements. However, this is already illegal under FDCA and FDA has all the same enforcement authority as is in this new act.

So Congress didn’t really pass a totally useless piece of legislation, did it?  The lack of any explanation by the FDA in the FR notice of what this is supposed to address suggests to me that they have no idea why this was enacted either.

If any readers have any more info on this please comment. The Food Law Prof Blog appears to be at a loss for words too.

The American Herbal Products Association (AHPA) has requested that FDA clarify its policy on products combining over-the-counter drugs and dietary supplement ingredients. To read the letter from AHPA to FDA, click here.

According to this article in Natural Products Insider, AHPA sent the inquiry following the launch of an “analgesic phytosterol supplement”, Bayer Aspirin with Heart Advantage, by Bayer Healthcare; the product combines 81 mg of aspirin and 400 mg of sterols, and carries both OTC drug and dietary supplement labeling and claims.

In its May 29 letter, AHPA cited two past warning letters from FDA issued to companies marketing OTC-supplement combination products without first filing new drug applications. AHPA also referenced this 2000 letter from FDA in which the agency “strongly” recommended companies not to market such products, given possible health and policy issues.

To read the AHPA press release on this, click here.

Your editor, dietary supplement regulatory attorney Joel Rothman, and seasoned supplement industry regulatory consultant Vincent Annunziata, in cooperation with the law firm of Seiden, Alder, Matthewman & Bloch, P.A., have announced the formation of a new FDA regulatory consultancy for small to medium size dietary supplement companies, Nutritional Supplement Compliance Solutions, LLC and the launch of its website at nutricompliance.com.

“The challenges facing small to medium sized supplement firms are significant and growing,” said Joel Rothman, President of NutriCompliance. “New regulatory requirements for adverse event reporting (AER) and good manufacturing practices (GMP) are forcing supplement firms to take on new and greater responsibilities they may not have the resources internally to manage. NutriCompliance helps small to medium sized companies “bridge the gap” and meet the demands of today’s expanded regulatory environment.”

Annunziata is a supplement industry veteran whose regulatory experience includes work for industry giants like Life Extension Foundation and Jarrow Formulas. “NutriCompliance provides a platform for us to serve the needs of small to medium sized supplement companies to help solve their regulatory challenges,” said Annunziata. “Whether it is FDA compliance, FTC review, or any other regulatory issue, NutriCompliance has the experience and strength to assist its clients to successfully address these challenges.”

Based in Boca Raton, Florida, NutriCompliance serves nutritional and dietary supplement companies with vitamin, mineral, herbal, homeopathic, and proprietary blend products throughout the state and the nation. For more information on the services provided by NutriCompliance, please contact info@nutricompliance.com or call 561-416-0170.