FDA Law Blog

Another Shot Across the Bow of Cholesterol Health Claims – Pharmavite Changes Labels and Advertising for CholestOff in Face of FTC Challenge

By Wes Siegner & Ricardo Carvajal –

The FTC has closed its investigation of Pharmavite’s advertising campaign for CholestOff dietary supplements, which contain free form phytosterols and are promoted to lower cholesterol.  According to the April 2009 letter, Pharmavite used “advertising and labeling claims that CholestOff is clinically proven to lower to lower cholesterol and, more specifically, that CholestOff lowers LDL cholesterol up to 24% or 42 points.”  FTC questioned whether there is adequate substantiation for these claims because most studies testing the effect of phytosterols on cholesterol involve either conventional foods, or dietary supplements that contain phytosterols in their esterified form (CholestOff contains phytosterols in their free form).  FTC also noted that the more specific cholesterol-lowering claims made by Pharmavite “singled out the most dramatic reductions” in the underlying studies.  FDA recently challenged similar claims made for General Mill’s Cheerios based on the allegation that the claims are illegal drug claims.

FDA regulations authorize health claims that “describe the relationship between diets that include plant sterol or stanol esters and reduced risk of heart disease,” but only in the labeling of certain types of conventional food and dietary supplements, and only those that contain esterified phytosterols (21 C.F.R. § 101.83).  In 2003, FDA issued a letter stating that the agency would consider exercising enforcement with respect to these requirements, thereby opening the door to the use of the claims in the labeling of other types of conventional food and dietary supplements, including those that contain phytosterols in their free forms. 

Citing FDA's letter of enforcement discretion and Pharmavite’s agreement to remove the claims to which the FTC had objected, FTC decided not to take action against Pharmavite’s more general claims even though in the FTC’s view there are concerns about whether even these claims are substantiated.

President Obama Sets New Criteria for Preemption in Federal Agency Rules and Orders Sweeping Review of Existing Rules

By JP Ellison –

In a Memorandum to the heads of Executive Departments and Agencies dated May 20, 2009, with the Subject Line “Preemption” (the “May 20, 2009 Memorandum”), President Obama stated that “executive departments and agencies have sometimes announced that their regulations preempt State law, including State common law, without explicit preemption by the Congress or an otherwise sufficient basis under applicable legal principles.”

The May 20, 2009 Memorandum cross-references Executive Order (“EO”) 13132, which President Clinton issued on August 4, 1999, and the May 20, 2009 Memorandum includes as one of its criteria that an agency or department can only make a preemption statement in regulations when it is consistent with EO 13132 to do so. 

Significantly, the May 20, 2009 Memorandum seems to go beyond EO 13132.  For one thing, unlike EO 13132, the May 20, 2009 Memorandum specifically calls out “state common law” for preemption protection.  EO 13132, which was negotiated with state and local government organizations, did not specifically address common law preemption. 

In addition to compliance with EO 13132, the May 20, 2009 Memorandum also requires that any new regulations must contain preemption provisions in the codified regulations if there are preemptions statements in the preamble.

The May 20, 2009 Memorandum further requires heads of departments and agencies to look back 10 years to determine whether regulations issued in that time frame, “contain statements in regulatory preambles or codified provisions intended by the department or agency to preempt state law.”  Once any such regulations are identified, the departments and agencies are required to “decide whether such statements or provisions are justified under applicable legal provisions governing preemption.”  Other than EO 13132, the May 20, 2009 Memorandum does not identify any guidance for this review.  Finally, the May 20, 2009 instructs heads of departments and agencies to take “appropriate action” if they conclude that existing preemption provisions cannot be justified, “which may include amendment of the relevant regulation.”

It is difficult to predict how may regulations may be affected by the review ordered by the May 20, 2009 Memorandum.  That being said, FDA’s changes being effected (“CBE”) regulation, which was finalized in August 2008 and contains preamble preemption statements, is certainly on the FDA/HHS list of regulations to be reviewed. 

Unlike the FDA regulation at issue in Wyeth v. Levine, the preemptive effect of the CBE regulation was subject to notice and comment rule-making.  While the absence of notice and comment rulemaking seemed to matter to the Supreme Court in Wyeth, the presence of notice and comment rulemaking has not been given much weight by several courts that have considered the preemptive effect of the CBE regulation in connection with private tort suits against drug manufacturers.

It will be interesting to watch how the regulation review process unfolds across departments and agencies and in the courts.  It certainly seems like a significant undertaking.  Moreover, as the Supreme Court recently noted in FCC v. Fox Television Stations, Inc.:

To be sure, the requirement that an agency provide reasoned explanation for its action would ordinarily demand that it display awareness that it is changing position. An agency may not, for example, depart from a prior policy sub silentio or simply disregard rules that are still on the books. See United States v. Nixon, 418 U. S. 683, 696 (1974). And of course the agency must show that there are good reasons for the new policy.

Thus, even when the agencies have completed the process outlined in the May 20, 2009 Memorandum – which could take years – one can imagine court challenges and litigation that could go on even longer.

In the interim, it will also be interesting to see whether the plaintiff’s bar can make use of the President’s statement that there are unspecified federal regulations containing preemption provisions that  lack “sufficient basis under applicable legal principles.”  While the Memorandum states that it “is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person” (emphasis added), it would be surprising if a citation to this Memorandum did not appear in a preemption brief soon. 

FDA Toughens Up on New Dietary Ingredients?

By Ricardo Carvajal –      

On May 11, FDA announced the condemnation and forfeiture of $1.3 million worth of dietary supplements marketed to body builders because the supplements contain “one or more unapproved food additives and/or new dietary ingredients for which there is inadequate information to assure that they do not present a significant or unreasonable risk of illness or injury.”  The former would constitute a violation of FDC Act § 402(a)(2)(C)(i) and the latter a violation of section 402(f)(1)(B).  Laboratory tests revealed that the products contained one or more of the steroids 1,4,6-androstatriene-3,17-dione (or “ATD” or 1,4,6-etioallocholan-dione) and 3,6,17-androstenetrione (or “6-OXO”), which are promoted as testosterone boosters.  FDA does not contend that the products present a hazard; the agency contends only that it “has no scientific information concerning the safety of the condemned products or their ingredients.”  FDA recommends that consumers discuss their use of the supplements and any related adverse events with health care professionals.

With the exception of a flurry of warning letters issued to marketers of androstenedione supplements in 2004, FDA has made little use of its authority under FDC Act § 402(f)(1)(B).  We’ll soon know whether this latest action is part of a similarly targeted effort, or is the first sign of a broader intent to get tough on new dietary ingredients that the agency considers unsafe within the meaning of the FDC Act.

FTC Wins Summary Judgment Against Marketer of Weight Loss Products

By Ricardo Carvajal & John R. Fleder –      

In Federal Trade Commission v. Medlab, Inc., the United States District Court for the Northern District of California granted summary judgment on April 21, 2009, to the FTC in an action against a marketer of weight loss products, which the FTC alleged had engaged in false advertising and deceptive business practices.  Defendants claimed in their advertising that their products quickly caused substantial weight loss with no dieting or exercising (and that this effect had been demonstrated in clinical studies), and that their products caused permanent weight loss.  In support of its decision, the court cited expert testimony that defendants’ claims were “clearly outside the realm of plausible science.”  Both individual and corporate defendants are liable for restitution in the amount of $2.7 million, which the court calculated by reference not just to profits, but to “the full amount lost by consumers.”

Would Dietary Supplements and Cosmetics Find a Home in a New Food Safety Administration?

By Ricardo Carvajal –      

Among the myriad proposals to overhaul the nation’s ailing food safety system, at least one calls for splitting off FDA’s food safety programs and incorporating them into a new Food Safety Administration ("FSA") within the U.S. Department of Health and Human Services.  That’s the tack taken in a report issued by the non-profit Trust for America’s Health titled “Keeping America’s Food Safe: A Blueprint for Fixing the Food Safety System at the U.S. Department of Health and Human Services.”  The report appears to have been strongly influenced by a paper included as an appendix titled “Restructuring Food Safety at HHS: Design and Implementation.”  That paper caught our eye because it was authored in part by Michael Taylor, formerly Deputy Commissioner for Policy at FDA, and now on faculty at the George Washington University School of Public Health.

Mr. Taylor’s paper raises the question of whether FDA’s dietary supplements and cosmetics programs should be housed in a new FSA or in the medical products agency that would remain once FDA’s food safety functions have been split off.  The paper acknowledges that dietary supplements “are categorized legally as foods and housed in CFSAN.”  However, the paper appears to suggest that perhaps the dietary supplement program should be housed in the medical products agency because:

the supplement category includes not only vitamins, minerals and other clearly nutritional substances but also herbal products and others that are marketed and sought after for their drug-like effects.  In fact, the issue of whether supplement claims cross the line to become, legally, drug claims is a recurring issue.

Similarly, with respect to cosmetics, that paper notes that “one of the recurring issues in cosmetic regulation is whether marketing claims and intended uses for some cosmetic products render them legally drugs.”

It strikes us as curious that the decision of where to house the dietary supplement and cosmetics programs would be based to any degree on the fact that unlawful marketing claims might be made for those products (a problem that needs to be addressed through enforcement), or that some consumers might seek those products out for their “drug-like” effects (what is to become of coffee?).  In any case, we thought that Congress had definitively settled the question as to how dietary supplements should be regulated – as food – and that nothing about the recent or current food safety crises suggests otherwise.  As for cosmetics, their regulatory paradigm has long resembled the one for foods much more strongly than the one for drugs.

It’s not difficult to imagine how the fate of the dietary supplement and cosmetics industries could depend on whether they’re housed in a new FSA or a medical products agency.  As the paper acknowledges in a masterful bit of understatement, “[t]he issue is of great interest to the regulated industries and other stakeholders and thus requires careful consideration.”

Lessons to be Learned from the Curious Case of Lawyer Paul Kellogg

In the latest “Enforcement Corner” column for the Food and Drug Law Institute’s Update publication, Hyman, Phelps & McNamara, P.C. attorneys JP Ellison and John R. Fleder discuss the indictment, trial, conviction, and sentencing of Berkeley Nutraceuticals’ former in-house counsel Paul Kellogg.  Mr. Kellogg’s conviction arose out of two distinct series of events – one that the government alleged was designed to cover up an FDA violation, and another that the government alleged was designed to evade the Federal Trade Commission (“FTC”).  The article notes that “[i]f Kellogg’s conviction for conspiracy to obstruct the FDA seems like the work of a criminal mastermind, then Kellogg’s conspiracy conviction relating to the FTC may largely appear that of the unwitting dupe.”  The authors go on to discuss what lessons can be learned from Mr. Kellog’s case. 

GAO Urges Increased Oversight and Consumer Understanding of Dietary Supplements, Expresses Concern Over Functional Foods

By Riëtte van Laack –      

The U.S. Government Accountability Office ("GAO") has released a report that calls for FDA to take further actions to improve oversight and consumer understanding of dietary supplements. In its 2009 Report, GAO reviews developments since its previous report in 2000.  Significant developments are FDA’s actions concerning reporting of adverse events for dietary supplements and issuance of the Current Good Manufacturing Practice regulations for dietary supplements. Nevertheless, GAO remains concerned about FDA’s oversight of dietary supplements.  It concludes that FDA needs more resources and authority to regulate dietary supplements to address safety concerns.

In the report, GAO recommends that FDA request additional authority to oversee dietary supplements, issue the long overdue guidance on new dietary ingredients, clarify the boundary between dietary supplements and foods with added dietary ingredients, and take steps to improve consumer understanding of dietary supplements.  To enable greater oversight of the dietary supplement industry, GAO recommends that dietary supplement establishments be required to identify themselves as such when registering pursuant to the existing registration requirements under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.  In addition, dietary supplement companies should be required to annually submit a list of all dietary supplements and labels for the products they market.  GAO further recommends that the requirements for reporting adverse events be expanded to include minor adverse events.  However, as FDA pointed out in its comments to GAO’s recommendations, this expansion might backfire; the huge increase in adverse event reports might hinder finding meaningful signals amidst the noise.

In its report, GAO also expressed concerns regarding conventional foods containing dietary ingredients, such as energy drinks.  Specifically, GAO expressed concerns that the dietary ingredients may not be generally recognized as safe.  However, “FDA officials told [GAO] that the current regulatory framework is sufficient to identify and act on safety concerns regarding” such products.  GAO did not make recommendations specifically addressing functional foods.

FDA Confirms that the Term “Dietary Supplement” Is a Legal Statement of Identity for Dietary Supplement Products and that FDA Guidance to the Contrary is in Error; State Regulators may Remain Confused and Have Taken Enforcement Action

By Wes Siegner –  

In April 2005, FDA published guidance for industry on dietary supplement labeling, “A Dietary Supplement Labeling Guide.”   Chapter II of this guidance contains FDA’s views on how to fulfill the statement of identity requirement for dietary supplements contained in 21 C.F.R. § 101.3(g). 

This portion of the guidance contains the following question and answer:

Can the term "dietary supplement" by itself be considered the statement of identity?

No. This term by itself is not appropriately descriptive to be a statement of identity.  21 CFR 101.3(g)

The regulation cited is at best ambiguous as to the correct answer to the question posed.  Nonetheless, prior to the issuance of the guidance in 2005 the vast majority of dietary supplement products were labeled with “Dietary Supplement” as the only statement of identity, and this situation has not changed since FDA issued the guidance, although some companies have changed their labels to comply with the guidance.  FDA has, to our knowledge, not taken enforcement action to force industry to change, which likely explains the lack of any real interest in the question of whether the guidance is correct as to whether the term “dietary supplement” alone meets the applicable statutory and regulatory requirements.

This question became a sticking point in recent efforts to settle a multistate investigation of a dietary supplement manufacturer, and the state regulatory authorities involved were understandably confused by FDA’s guidance.  As a result, this firm submitted our analysis of the relevant statutory and regulatory requirements to FDA’s Center for Food Safety and Applied Nutrition ("CFSAN") by e-mail, the relevant substance of which follows.

Section 403(s)(2)(B) of the Federal Food, Drug and Cosmetic Act ("FDC Act"), 21 U.S.C. § 343(s)(2)(B), provides that a dietary supplement is misbranded if “the label or labeling of the dietary supplement fails to identify the product by using the term ‘dietary supplement,’ which term may be modified with the name of such an ingredient.”  Therefore, the statute, which is controlling, specifies that the use of  "dietary supplement" alone as the statement of identity is acceptable, but that other words may be added.

FDA’s regulation, if read alone without reference to the preamble, is less clear and is likely the source of the confusion in the guidance document.  The applicable regulation states that “[d]ietary supplements shall be identified by the term 'dietary supplement' as a part of the statement of identity ... .”  21 C.F.R. § 101.3(g).  It is possible to read this regulation as meaning that the statement of identity must include more than just the words "dietary supplement."  However, this reading would conflict with the statutory wording.  FDA’s preamble to the final rule establishes that there is no inconsistency, and that the correct reading of § 101.3(g) is that the use of  the term "dietary supplement" alone as the statement of identity is acceptable.

FDA’s preamble states that:

Section 201(ff)(2)(C) of the act, in defining the term ``dietary supplement,'' mandates that such a product must be labeled as a dietary supplement. Section 403(s)(2)(B) of the act states that a food shall be deemed to be misbranded if it is a dietary supplement, and the label or labeling of the dietary supplement fails to identify the product by using the term ``dietary supplement, which term may be modified with the name of such an ingredient.'' Section 403(i)(1) of the act requires that a food label must bear the common or usual name of the food, that is, a statement that identifies the food. Dietary supplements are labeled subject to the provisions of section 403(i)(1) of the act (see the last sentence of section 201(ff) of the act). Thus, when the act is read in its entirety, it is clear that sections 201(ff)(2)(C), 403(s)(2)(B), and 403(i)(1) of the act require that the statement of identity of a product that is marketed as a dietary supplement identify the product as such.

FDA's longstanding regulations lead directly to this result. Section 102.5 (21 CFR 102.5) sets out how the common or usual name of a nonstandardized food is to be derived. Under this provision, the common or usual name must accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food. The basic nature of a dietary supplement is that it is a dietary supplement.  This is the point made in both sections 201(ff)(2)(C) and 403(s)(2)(B) of  the act.  Thus, under 102.5(a), the common or usual name of these products must, at least in part, identify them as a dietary supplement.

62 Fed. Reg. 49,826, 49,827 (Sept. 23, 1997).  The preamble clarifies that the words "as part of" in § 101.3(g) mean that the statement of identity should include the term "dietary supplement" "at least in part."  Stated differently, the preamble establishes that the correct reading of § 101.3(g), consistent with the statute, is that "dietary supplement" satisfies the statement of identity requirement under § 101.3(g), but that additional words may be included.

Consistent with our reading of the statute and regulation, in its press release concerning this rule, the Department of Health and Human Services stated that “[a] statement of identity will appear on the front panel of the product label. The statement must use the terms "dietary supplement" or a term identifying the contents of the product, such as "Vitamin C supplement" or "Herbal supplement."   

A senior official within CFSAN, has confirmed that CFSAN has considered this issue and agrees that FDA’s guidance is incorrect as to the answer to the question posed in the guidance, “[c]an the term ‘dietary supplement’ by itself be considered the statement of identity,” and that the correct answer should be “Yes” rather than “No.”  However, FDA has also indicated that the agency is not likely to correct this guidance anytime in the near future. 

Given the increased number of multistate investigations of the supplement industry, manufacturers responsible for labeling dietary supplements should be aware that Texas  authorities, even after learning that FDA agrees that the guidance is incorrect and being reminded that such guidance is not binding on FDA or industry, have stated their intent to enforce Texas’ view of the statement of identity requirement as expressed in the guidance.  Other states involved in the multistate investigation appeared to understand that, given the lack of ambiguity in the FDC Act, FDA’s acknowledgement of the error, and the lack of any state requirement of a different statement of identity, there is no legal basis for state enforcement that is inconsistent with the FDC Act.  Should Texas or any other state attempt to enforce the erroneous view expressed in the FDA guidance, the manufacturer targeted would have a strong basis for refusing to comply and litigating this issue.

Good News on FDA’s Phantom “Domestic Address” Requirement for OTC Drugs and Dietary Supplements; In a Tough Economy, Industry Could Save $84M – or More – by Doing Nothing

By Cassandra A. Soltis & Wes Siegner –  

Previously we have commented on FDA’s draft guidance originally issued on January 2, 2008 and recently reissued again in draft form on December 11, 2008 (here and here).  Both draft guidance documents assert that, in the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006, Congress's use of the term "domestic address" in sections 403(y) and 502(x) of the Federal Food, Drug, and Cosmetic Act ("FDC Act") is “a clear and unambiguous directive” that all labels for dietary supplement and OTC drug products (other than those approved through the NDA process) be revised to permit consumers to report adverse events.  Industry has submitted numerous comments pointing out that FDA’s reading of the “domestic address” requirement is obviously flawed and contradicted FDA’s longstanding regulations, 21 C.F.R. §§ 101.5(d) and 201.1(a), requiring that all dietary supplement and OTC drug labels bear the “name and place of business” of the manufacturer, packer or distributor of the product.

FDA’s two February 24, 2009 Federal Register publications (here and here) estimate the cost in terms of hours of compliance with FDA’s draft guidance, which, according to a March 2, 2009 Tan Sheet article, FDA states is equivalent to just under $44M for dietary supplements and $40M for OTC drugs.  These estimates beg the question – why would there be any cost at all when FDA has issued its views in non-binding draft guidance, the views expressed in the draft guidance are flatly contradicted by existing FDA regulations, and there is little, if any, risk that FDA would ever enforce the “domestic address” requirement?  Those companies that understand the legal requirements and FDA’s enforcement options would likely choose to do nothing, for a cost of $0.

FDA’s labeling initiative is a flawed effort to badger the dietary supplement and OTC drug industries into making labeling changes that are irrational, both from a cost and a public health perspective.  FDA’s argument is that consumers, armed with a phone book or even the Internet, need more information than the name and place of business of the company to be able to report an adverse event, and that Congress recognized the problem and therefore used the term “domestic address” to clarify that the name and place of business was insufficient.  This argument ignores the lack of any evidence of congressional intent as well as the intent of FDA’s “name and place of business” regulations, which are also aimed at company contact and have successfully achieved that goal for decades.  In addition, FDA’s view runs counter to the increased access to contact information in the modern world, and the ability of consumers to report adverse events to medical professionals and to FDA, should they somehow be unable to locate the company or, as is usually the case, prefer not to report to the company.  The labeling changes FDA seeks would have no effect on consumer reporting, but would cost industry millions.

Finally, industry should understand that the closing sentence of both draft guidances, that “FDA intends to begin enforcing the [labeling] requirements . . . on or after January 1, 2010,” is either a bluff or was written by someone who does not understand the non-binding nature of FDA guidance (see 21 C.F.R. § 10.115(d)(1)).  Any effort to enforce the “domestic address” requirement would be at least an implied threat of litigation, which would force the agency to confront several major obstacles, not the least of which is the logic of its own existing “name and place of business” regulations and the non-binding nature of FDA’s guidance, all for a cause that must be of questionable merit even to those within the agency.  Even assuming FDA might push to enforce the requested label changes, convincing attorneys at the Department of Justice that such a case would be worth bringing would be difficult, if not impossible.  The risk of litigation would be at best remote, and therefore the threat of litigation of little use as an enforcement tool.

The most likely outcome of FDA’s labeling initiative is that there will be little if any change in labels and therefore no cost to industry.  These days, no added costs would be very good news.

Call Renewed For FDA to Preempt Proposition 65

By Ricardo Carvajal –      

In January 2008, FDA received a citizen petition asking it to “issue a formal determination that when applied to foods and dietary supplements, California's Proposition 65 causes consumer confusion, ‘misbrands’ safe and wholesome products, and frustrates FDA's ability to carry out its statutory mandates.”  California’s recent Proposition 65 action against lead in dietary supplements appears to be reinvigorating that effort.  FDA has received a supplemental submission to the docket established for the petition noting that California’s action is founded on an FDA survey showing that the products at issue posed no safety concerns.  The supplemental submission also highlights the cooperation between California’s Attorney General (AG) and private plaintiffs in the case, and attacks the AG’s inclusion of claims under the state’s unfair competition law, which would give rise to additional penalties and extend the statute of limitations.  If the recent news about the potential presence of mercury in high fructose corn syrup begets another Proposition 65 action, we’re betting that this citizen petition will find a few more friends.