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January 31, 2014

Liquid Dietary Supplements and Beverages: How Do You Distinguish?

liquids.jpgWhether a beverage or a dietary supplement, liquid products are marketed more than ever before--now containing a wider array of ingredients, for many more intended uses and including traditional food substances, but at levels far exceeding previously used amounts. So how does one know if a liquid product is a beverage or a dietary supplement? And what regulations must be followed? To answer those questions, FDA has issued nonbinding recommendations in two new guidances this month: Distinguishing Liquid Dietary Supplements from Beverages and Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements. FDA hopes that these guidances will help the industry avoid misbranding with inconsistent product category labeling and adulteration for failure to meet the proper regulations.

When distinguishing between beverages and dietary supplements, as a general rule, dietary supplements are meant to supplement the diet, and beverages are for quenching thirst and providing fluid, nutritive value, taste or aroma. FDA's Guidance sets out the following factors to consider in distinguishing between the two types of liquid products: labeling and advertising, product name, product packaging, serving size and recommended daily intake, recommendations and directions for use, marketing practices, and composition of the liquid product. The Guidance provides examples of how the factors can come into play in a determination. It is likely that a combination of factors, not one, will be determinative of a product's category. For example, even if the label of a liquid product contains a Supplement Facts Panel, it could still be considered a "beverage" if it also contains a statement that the product "refreshes," or the product could be a "food" if the label contains a picture of the liquid being poured onto a salad. The product name could also be determinative that a product is likely a "beverage", if the product name contains conventional terms for beverages, like "drink", "soda", "orange juice", "iced tea", "bottled water", or "coffee". The product packaging is another determinant and, if the packaging is reclosable, is shaped similar to a common beverage package, or contains a single serving, then it is likely a "beverage". The serving size or recommended daily intake may also indicate which category a liquid product falls under. For example, if the product is intended to be consumed all at once or contains a significant part of the entire daily drinking fluid intake for the average person then it is likely a "beverage". Interestingly, marketing practices, another factor, such as metatags for "sodas," "juices" or "beverages," or paying for store shelf placement with other beverages could be determinative of a "beverage". But the product is not necessarily a "beverage" if the marketing says the product should be taken with a meal, since dietary supplements are often recommended for use along with a meal. Finally, the composition of a liquid product may be determinative, although there is a lot of overlap now with both categories containing amino acids, proteins, and vitamins. Similarly, merely adding a dietary ingredient does not make a product a "dietary supplement".

Once the factors are considered to determine whether a liquid product is a "beverage" or a "dietary supplement", the type of product controls which regulations must be met. For beverages, a substance can be generally recognized as safe ("GRAS") for its intended use based upon generally-available evidence of safety recognized by experts. But unless GRAS for its intended use or exempt, substances intentionally added to "beverages" are "food additives", which require premarket approval based upon safety data. FDA issues regulations for approved food additives that specify the conditions for which the substance is safe and can be used. Accordingly, non-dietary ingredients added to supplements, such as binders, excipients and fillers, however, must meet food additive requirements or be GRAS. On the other hand, dietary ingredients included in dietary supplements are not required to be GRAS and are exempt from food additive regulations but still must not be adulterated, and, if new, must meet new dietary ingredient requirements. No matter a "beverage" or "dietary supplement", the guidances remind the industry to make sure the labeling is not false or misleading, and if included, to make sure health claims, nutrient content claims, and structure function claims are proper.

January 8, 2014

Dietary Supplements Under Closer Scrutiny

dietary supplements.jpgIn mid to late December 2013, FDA appeared to be taking a closer look at dietary supplement claims and products, particularly those with health claims or potentially dangerous ingredients. Three recent actions/notifications that took place within days of each other worth note include actions against Risingsun Health (bloodroot-containing products with claims to treat cancer), Star Scientific, Inc. (anatabine-containing products with claims to treat traumatic brain injury ("TBI") and other ailments), and Blunt Force Nutrition (synthetic anabolic steroid with claims for muscle growth).

On December 19, 2013, FDA posted a News Release that on December 4, 2013, Risingsun Health, a Livingston, Montana dietary supplement maker was found in civil contempt of violating the terms of a consent decree of permanent injunction that had resolved a case brought by FDA against the company and its owner in February 2010. The consent decree had barred the company from developing and selling topical bloodroot and graviola products, new drugs, new animal drugs, and dietary supplements. The 2010 case concerned the company's advertisements on various websites and sales of unapproved drugs that claimed to treat cancer, and the decree was entered in November 2010. In February 2013, the U.S. sought an order of civil contempt, because Toby McAdam, owner of Risingsun Health, and his company continued to manufacture and distribute products, including products containing bloodroot, which violated the decree, after FDA sent several letters concerning the alleged violative conduct. Federal judge Sam E. Haddon, District of Montana, held a hearing on the government's contempt motion on October 21, 2013. The Court found McAdam in contempt, requiring him to cease selling dietary supplements and new drugs and to pay both $80,000 in liquidated damages and $4,936.48 in attorneys' fees. Regarding the finding, Melinda K. Plasier, Associate Commissioner for Regulatory Affairs, stated, "The court's ruling will ensure that this business cannot harm consumers physically or economically by selling unapproved and deceptive dietary supplements."

Continue reading "Dietary Supplements Under Closer Scrutiny" »

January 18, 2013

Safe Harbor Provision Case Not Selected for Supreme Court Review

Thumbnail image for Thumbnail image for supremecourt.pngEarlier this week, the U.S. Supreme Court denied GlaxoSmithKline's certiorari petition in a case that would have helped clarify the scope of 35 U.S.C. § 271(e)'s safe-harbor provision. The issue facing the Court was whether section 271(e)(1) applies to postmarketing activity as well as premarketing activity.

Section 271(e), which states that it is not an act of infringement to make, use, offer to sell, or sell a patented invention "solely for uses reasonably related to the development and submission of information under [federal drug laws]," does not include a time limitation. The question about timing was highlighted in two recent Federal Circuit cases. In Classen Immunotherapies, Inc. v. Biogen Idec, 659 F.3d 1057 (Fed. Cir. 2011), the Federal Circuit explained that "§ 271(e)(1) is directed to premarketing approval of generic counterparts before patent expiration." Last year, however, a different panel of judges in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc., 686 F.3d 1348 (Fed. Cir. 2012) held that post-approval studies performed for the FDA fall within § 271(e)(1)'s safe harbor and explained that Classen held that 271(e)(1) "does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained."

As previously blogged on here, the Solicitor General had urged the Supreme Court to deny GSK's petition in the Classen case. Despite a belief that the Federal Circuit erred in Classen, United States Solicitor General Donald Verrilli offered the following reasons why the Supreme Court should deny certiorari: (1) the Federal Circuit's Momenta decision sufficiently clarified and narrowed the Classen holding; (2) it was unclear whether the safe harbor applied to the types of patents at issue in the Classen case; and (3) the petitioners were not entitled to the safe harbor protection regardless of the Supreme Court's interpretation of the provision.

Continue reading "Safe Harbor Provision Case Not Selected for Supreme Court Review" »

July 6, 2012

Nanotechnology: User Fee Bill Increases Funding for FDA Studies

nanotechnology.bmpThe Food and Drug Administration Safety and Innovation Act, otherwise known as the User Fee Bill, has passed through Congress and awaits the President's signature. This Bill, mostly known for implementing user fees for generic drug applications, also provides new programs to foster the study of nanomaterials in products regulated by FDA. Section 1126 of Title XI, Subsection C calls for the Secretary to "intensify and expand activities related to enhancing scientific knowledge regarding nanomaterials, ... to address issues relevant to the regulation of those products, including potential toxicology, the potential benefit of new therapies derived from nanotechnology, the effects of nanomaterials on biological systems, and the interaction of such nanomaterials with biological systems." This provision mirrors the Nanotechnology Regulatory Science Act of 2011 introduced by Sens. Ben Cardin (D-MD) and Mark Pryor (D-AR) last year, which stalled after its introduction in the Senate.

Nanomaterials utilize nanotechnology--manipulation of matter on the atomic and molecular scale. Nanomaterials, measured in billionths of a meter, range from 1- 100 nanometers (nm) and are used in a range of products, from paint and sunscreen to drugs and cosmetics. In 2010, the National Science Foundation estimated that nanotechnology-based products and manufacturing would add 2 million jobs and $1 trillion dollars in revenue to the world economy by 2015. These nanoproducts have different physical, chemical, and biological properties than conventionally-scaled materials, and some speculate that these properties may involve unknown risks to humans and our environment.

Written by Caroline Bercier

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The importance of nanomaterials has been recognized for some time. President Clinton advocated nanotechnology research, and President George W. Bush increased funding for nanotechnology development in 2003 with the passage of The 21st Century Nanotechnology Research and Development Act. However, this will be the first time that Congress has mandated that FDA study nanotechnology to evaluate the safety and toxicity of nanomaterials in consumer goods and products.

Continue reading "Nanotechnology: User Fee Bill Increases Funding for FDA Studies" »

May 9, 2012

Clinical Investigator Disqualifications Extended to All FDA-Regulated Products

3699948229_d7732f8df0_o.jpgOn April 30, FDA published in the Federal Register final regulations amending the scope of its clinical investigator disqualifications. Now when the Commissioner determines that a clinical investigator is ineligible to receive one kind of test article (drug, device, animal drug), the clinical investigator is also ineligible to conduct any clinical investigation that supports an application for research or marketing for other FDA-regulated products, including foods and tobacco products. FDA amended its regulations "to protect the rights and safety of subjects involved in FDA-regulated investigations, and help[s] to ensure the reliability and integrity of the data used to support the marketing of products regulated by FDA."

According to FDA, the final rule was based on a recommendation from the General Accounting Office ("GAO") in September 2009. The GAO Report, Oversight of Clinical Investigators: Action Needed to Improve Timeliness and Enhance Scope of FDA's Debarment and Disqualification Process for Medical Product Investigators, stated that it was "critical for FDA to take action--and to have the authority to take action--to prevent clinical investigators . . . who engaged in serious misconduct from doing it again, whether in research that involve drugs, biologics, or devices." FDA is also amending its regulations for informal hearings under 21 C.F.R. Part 16 by changing the scope of certain provisions that were "inadvertently omitted."

FDA proposed the rule in the Federal Register on April 13, 2011 and received only two comments. FDA, however, managed to convert one of the filed comments to ten points to address in the preamble to the final rule. First, FDA clarified the "repeatedly or deliberately" language in the regulations for when a clinical investigator may be disqualified for repeatedly or deliberately failing to comply with FDA's applicable clinical investigations regulations or deliberately submitting false information to the sponsor. FDA said "repeatedly" means more than once, which can be more than one time in a single study or in more than one study. "Deliberately" means "willful" conduct or with reckless regard, such as knowingly failing to comply with FDA's regulations or falsifying data. In another point, FDA clarified that FDA will place no limits on how far back FDA will investigate to find applications or submissions that may have been affected by a disqualified investigator. In yet another point, FDA summarized the notification process for how sponsors become aware of an clinical investigator's ongoing disqualification process, including redacted letters on FDA's website. In the final point, FDA indicated how FDA notifies sponsors that clinical investigators have been reinstated--once again, primarily FDA's website.

Continue reading "Clinical Investigator Disqualifications Extended to All FDA-Regulated Products" »

April 24, 2012

FLH Partner Brian J. Malkin Attends FDLI's Annual Conference in Washington, D.C. on April 24-25

FLH Partner Brian Malkin will attend the Food and Drug Law Institute's ("FDLI's") Annual Conference in Washington, D.C. on April 24-25. For 55 years, FDLI's Annual Conference has been considered the venue for food and drug law lawyers and professionals to hear from FDA and industry about new and emerging topics covering all the products FDA regulates. FDLI has reported that this year's event is expected to draw more than 600 attendees, who will hear directly from FDA's key leaders including Commissioner Margaret Hamburg; Deputy Commissioners Deborah Autor, Stephen Spielberg, and Michael Taylor, various representatives from FDA's six product Centers; newly-appointed Chief Counsel Eliabeth Dickinson, as well as a number of former Chief Counsels. An updated agenda is available here.

FDA Lawyers Blog is a Media Partner of FDLI's 55th Annual Conference. Prior to FDLI's Annual Meeting, Mr. Malkin will participate in a FDLI Monograph Committee Meeting on April 23 and will be working out of Frommer Lawrence & Haug LLP's Washington, D.C. office next week. Mr. Malkin looks forward to seeking you and catching up at FDLI's Annual Conference this year.

FDLILogo.jpg

April 16, 2012

FDLI's Annual Conference in One Week (April 24-25) in Washington, D.C.

FDLILogo.jpgFor more than 50 years, the Food and Drug Law Institute's ("FDLI's") Annual Conference has provided the venue for food and drug law professionals to discuss and debate emerging topics, as well as participate in valuable education programs. At this year's event, more than 600 attendees will hear directly from FDA leadership including Commissioner Hamburg; Deputy Commissioners Autor, Spielberg, and Taylor; representatives from FDA's six product Centers; Chief Counsel Dickinson and former Chief Counsels.

Programming at the Conference addresses a range of topics including: regulatory science; global developments and emerging markets; economic, legal and regulatory challenges of innovation; social media and mobile apps.

Join FDLI for the largest networking opportunity for food and drug law professionals. We look forward to seeing you at the 2012 FDLI Annual Conference next week.

FDA Lawyers Blog is a Media Partner of FDLI's 55th Annual Conference.

July 12, 2011

Dietary Supplement Legislation Introduced but Criticized for Being Duplicative

by Russell A. Garman, Ph.D.

The popularity of dietary supplements continues to catch the attention of the federal government. Aside from the draft guidance recently released by FDA clarifying the requirements on dietary supplement distributors and manufacturers containing a new dietary ingredient, on June 30 U.S. Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT) introduced the Dietary Supplement Labeling Act (S.1310).

The proposed legislation requires companies to submit to FDA a description of each dietary supplement product that they manufacture, a list of all ingredients in each product, and a copy of the label and labeling for each product. The Bill also requires FDA to work with the Institute of Medicine in determining dietary supplement ingredients and proprietary blends of ingredients that can cause potentially serious adverse events, drug interactions, contraindications, and other effects, and to establish a mandatory warning label requirement for these dietary supplement ingredients and blends of ingredients. In addition, the Bill requires FDA to establish a definition for the term "conventional food," taking into account conventional foods marketed as dietary supplements and products marketed dietary supplements that simulate conventional foods.

The Bill is purportedly in response to a recent controversy involving "Lazy Cakes" brownies, which contain the neurohormone melatonin. In his May 18, 2011 letter to FDA Commissioner Margaret A. Hamburg, M.D. , Durbin raised concerns with about Lazy Cakes and other baked goods containing melatonin that are marketed as dietary supplements and do not require FDA pre-market approval for safety and efficacy. And now with the proposed Billtion, Durbin is looking to curb this practice. Durbin points out that products such as Lazy Cakes, Drank, and Monster Energy Drink "market themselves as dietary supplements that are safe ways to relax or get a boost of energy, when in reality they are foods and beverages taking advantage of the more relaxed safety standards for dietary supplements."

However, critics have accused the Bill as undermining the dietary supplement industry and of giving FDA unnecessary power to address problems that it already has the authority to remedy. For example, some critics question why the provisions in the Bill apply to supplement manufacturers and do not address the issues surrounding the illegal sale of Lazy Cake, while others note that FDA already has the authority to take action against the producers of Lazy Cake for its violation of the law prohibiting the sale of a supplement as food, and yet FDA has not acted. Further, some point out that a new dietary ingredient (i.e., a new supplement) is already covered through the existing new dietary ingredient ("NDI") notification process. In a press release, the Council for Responsible Nutrition summarized many of these criticisms of the Bill: "The bill contains duplicative requirements that already exist under current law that gives FDA the proper legal authority to take action to protect consumers and maintain safety standards. FDA needs to continue working toward becoming a more efficient steward of its resources, and we continuously call on the Agency to use its power under the law."

July 5, 2011

Dietary Supplement Guidance Issued by FDA

by Andrew S. Wasson

Thumbnail image for dietary supplements.jpgFDA recently released a draft guidance clarifying the requirements that the Dietary Supplement Health and Education Act of 1994 ("DSHEA") places on distributors and manufacturers of dietary supplements containing a new dietary ingredient ("NDI"). In particular, the draft guidance ("Dietary Supplements: New Dietary Ingredient Notifications and Related Issues") describes when a distributor or manufacturer must notify FDA of an NDI and the types of information required by such a notification. FDA estimates that there are approximately 55,600 dietary supplement products on the market, and that FDA has received approximately 700 NDI notifications over the last 16 years. The draft guidance presents information in a question and answer format.

When Congress passed DSHEA in 1994, it created a new framework for the regulation of dietary supplements, which were previously regulated no differently than foods. Generally speaking, dietary supplements are not subject to pre-market approval, with the exception of a supplement containing an NDI. DSHEA defines an NDI as "a dietary ingredient that was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994." 21 USC § 350b. DSHEA provides that a dietary supplement containing a NDI is adulterated unless the supplement (a) "contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered" or (b) the firm submits a premarket notification to FDA seventy-five days prior to introducing (or delivering for introduction) a supplement containing an NDI into interstate commerce. A firm must show in its premarket notification that there is "a history of use or other evidence of safety" establishing that the dietary ingredient "will reasonably be expected to be safe" when used as directed.

As some industry observers are quick to point out, the draft guidance does not change the requirements set forth in DSHEA or the related regulations. The draft guidance subsumes its recommendations generally under three categories: (1) when is it necessary to provide a new dietary ingredient notification, (2) a description of NDI notification procedures and timeframes, and (3) what to include in an NDI notification. In broad strokes, FDA recommends including (1) a full description of the NDI's identity, composition, and the marketed dietary supplement, (2) the basis for considering it an NDI, (3) the recommended or ordinary conditions of use, (4) and "an explanation of how the history of use or other evidence of safety in the notification justifies the notifier's conclusion that the dietary supplement containing the NDI will reasonably be expected to be safe."

FDA suggests submitting comments within 90 days of the draft guidance's promulgation (June 29, 2010) to ensure consideration.

June 30, 2011

Global Product Safety and Quality Meets FDA

by: Howard Rosenberg. Ph.D.

The FDA recently released a report on the 'Pathway to Global Product Safety and Quality', it highlights yet again its problems in safeguarding America's food and medical products particularly in reference to imported goods. The concern for pharmaceuticals imported from facilities which, in the main, have not been inspected by FDA staff is a key part of U.S. Sen. Sherrod Brown's (D-OH) letter to the FDA. Senator Brown is a leading voice on the need to protect Americans from unsafe food and drug products. In 2008, he introduced the Transparency in Drug Labeling Act (S. 3633), which would require country-of-origin labeling for both active and inactive ingredients on all pharmaceuticals.

FDA Pathway to Global Product Safety and Quality

This new FDA document discusses the difficulties it faces especially in resolving such safety problems on its own. The report is a follow up to last September's GAO reports, GAO-10-961 and GAO-10-960, which pointed out the need for better long term planning to ensure import safety and improving knowledge about foreign manufacture and the number of foreign inspections.

The FDA states its " new approach rests on four core building blocks:

  1. FDA, in close partnership with its foreign counterparts, will assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world.
  2. With these coalitions, FDA intends to develop a global data information system and network in which regulators worldwide can regularly and proactively share real-time information and resources across markets.
  3. FDA will continue to expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities.
  4. FDA will effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties.

Continue reading "Global Product Safety and Quality Meets FDA" »

June 17, 2011

Nanotechnology Guidance Issued

by Erin A. Lawrence

nanotechnology.bmpOn June 9, FDA issued a draft guidance titled, "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology." Nanotechnology is the science of particles that are less than 100nm in size. Nanomaterials can have different chemical, physical, or biological properties than conventionally-manufactured products. FDA acknowledges the need to learn more about the potential role and importance of dimensions in the characteristics exhibited by engineered nanomaterials. The guidance is FDA's current thinking on whether FDA-regulated products contain nanomaterials or otherwise involve nanotechnology.

FDA will determine whether a product contains nanomaterials by considering whether the engineered material or final product has at least one dimension in the nanoscale range and whether the product contains physical or chemical properties that are attributable to its dimensions. These considerations apply to new products and when manufacturing changes alter the dimensions, properties, or effects of an FDA regulated product or any of its components.

FDA has yet to establish regulatory definitions of "nanotechnology," "nanoscale" or related terms. Currently, FDA addresses nanomaterials on a case-by-case basis using existing review processes. The National Nanotechnology Initiative Program defines nanotechnology as the "understanding and control of matter at dimensions between approximately 1 and 100 nanometers, where unique phenomena enable novel applications."

Nanotechnology has various potential applications. It can increase the bioavailability, decrease dosage, increase potency, and/or decrease toxicity of drugs. Additionally, nanotechnology can lead to better detection of pathogens, improve food packaging, and can be used cosmetics.

Continue reading "Nanotechnology Guidance Issued" »

May 20, 2011

PETITION ASSAILS FTC HEALTH CLAIM SUBSTANTIATION CRITERIA

by Charles J. Raubicheck

The group American Health Alliance ("AHA") has petitioned the Federal Trade Commission ("FTC") to rescind criteria the agency uses to judge the substantiation of health claims made in advertisements for foods and dietary supplements.

Alliance Petition Dietary Supplements

A health claim is a statement that consumption of a particular nutrient in a food or a dietary supplement may prevent or reduce the risk of contracting a particular disease. The petition contends that the FTC is improperly usurping powers of the FDA by requiring two clinical trials (the strict standard for drug approval) to support these advertising claims. Also, the petition maintains, FTC is unlawfully using the lack of FDA approval of specific health claims as a proxy for finding the claims unsubstantiated. (FDA has hardly approved any health claims, usually asking for more data).

In fact, the FTC has employed the above criteria in obtaining consent orders in several advertising enforcement cases involving probiotic and cold/flu immunity claims.

AHA calls FTC's actions a prior governmental restraint that unconstitutionally chills commercial free speech in the food and supplement industries.

March 7, 2011

Free Phytosterols Obtain Extension from FDA on Coronary Disease Health Claim

by Charles J. Raubicheck

Tetralogy.pngFDA has granted an extension of time, to February 21, 2012, allowing makers of dietary supplements containing non-esterified (free) phytosterols to submit further data warranting use of the health claim that these products may reduce the risk of coronary heart disease.

Phytosterols are plant-derived sterols that reduce cholesterol levels. The agency has proposed to allow the claim for esterified phytosterols (prepared with fatty acids), but is not yet convinced that the non-esterified (free) form is efficacious. Free phytosterols are used more frequently in dietary supplements because they permit the production of smaller, easier-to-swallow pills.

Several trade associations and companies petitioned for the extension. FDA terms its action an "exercise of enforcement discretion."

February 16, 2011

Dietary Supplements' Effects on Key Drug Transporters to Be Studied in Optiva-FDA Collaboration

by Andrew M. Nason

supplements.jpgOptivia Biotechnology Inc., a leading provider of in vitro transporter assay services, announced that it signed a collaboration agreement with the U.S. Food and Drug Administration ("FDA") to assess the effect of dietary supplements on key drug transporters. The collaboration aims to identify potentially harmful interactions between drugs and dietary supplements, such as a supplement interacting with acetaminophen or other drugs associated with liver toxicity. Estimates blame drug-induced liver toxicity for as many as five percent of all hospital admissions, and fifty percent of all acute liver failures. Drug transporters greatly influence the liver's disposition of a number of commonly used drugs, such as antibiotics, statins, and hypoglycemic agents.

Following a recent report from the International Transporter Consortium that identified the most clinically significant transporter-related drug-drug interactions, drug-nutrient interactions have become a growing area of interest for both the nutrition and pharmaceutical industries. As a starting point, Optivia and FDA will use Optivia's novel transporter technology platform to examine potentially harmful interactions between the most clinically relevant transporters and dietary supplements such as black cohosh, green tea, ginko biloba, kava, and usnic acid. The platform features polarized mammalian cell assays that closely model human biology.

"This project further advances Optivia's leadership position in the development of quantitative tools for optimizing the safety and efficacy of drugs," stated Yong Huang, Ph. D., president and chief executive officer of Optivia. "We are excited about this opportunity to expand the use of our technology to examine the role of dietary supplements in causing drug-related liver injury."

December 20, 2010

Dietary Supplement Makers Asked to Police Themselves More

by Howard E. Rosenberg, Ph.D.

army.mil-2007-05-31-135215.jpgIn a letter dated December 15, FDA warned makers of dietary supplements to police themselves and their suppliers and distributors, to ensure that drugs are not included in their products and to follow current Good Manufacturing Practices (cGMPs). The agency asked five trade organizations to do the same. FDA told the makers and distributors of dietary supplements that there are hundreds of products on the market that illegally contain drugs or compounds which act as drugs. Generally these supplements are labeled for weight-loss, bodybuilding and "sexual enhancers" and are illegal, because they contain known pharmaceuticals or similar chemicals, which effects on humans have not been studied or because they contain drug claims.

Although FDA actions have included recall of supplements and referral of companies for criminal prosecution, FDA believes the problem is still not being solved. The origin of the questionable supplements usually is not known, but many of the products come with Chinese writing, suggesting that they are made in China. Most of the questionable supplements are sold over the Internet. Federal law requires that supplement makers be responsible for marketing a safe product and for them to be manufactured to cGMP. The manufacturers don't have to prove the safety or effectiveness of their products.

Following the introduction of the Dietary Supplement Regulation Bill in 2007, the Indian SME segment has been finding it difficult to enter the U.S. market. Owing to this regulation, which requires the products are manufactured to cGMP, the U.S. dietary supplement market is dominated by the large players from India who have already invested in the high level of manufacturing and quality control that the regulation requires. cGMP compliance has up until now been viewed as cumbersome and an expensive exercise for these SMEs. Coincidentally, a recent article in Pharmabiz.com (Dec. 10, 2010) stated that the U.S. dietary supplement market is valued at $25 billion and that Indian Small and Medium Enterprises (SMEs), specializing in the manufacture of raw materials for dietary supplements, are eyeing this as a big opportunity. They are gearing up to obtain the mandatory certifications.

In view of latest FDA's concerns, it appears that self-policing will not be enough to ensure that dietary supplements are both free from illegal substances and routinely manufactured to cGMP.