Eight Isn’t Enough: American Farm Bureau Permitted to Intervene In WV Poultry Dust Suit against EPA

By Stewart D. Fried and John G. Dillard

On October 9, 2012, a federal judge in Elkins, West Virginia, issued an order allowing the American Farm Bureau Federation and the West Virginia Farm Bureau (Farm Bureau) to intervene in a lawsuit filed by a West Virginia poultry producer against the U.S. Environmental Protection Agency (EPA), Alt v. EPA.  The Farm Bureau’s intervention will result in bolstering the farmer’s efforts to challenge EPA’s position on “dust and feather” discharges in one of the first post-Sackett challenges to EPA authority to regulate Concentrated Animal Feeding Operations (CAFO).

Lois Alt is the owner and operator of Eight Is Enough, a poultry broiler operation near Old Fields, West Virginia.  Alt raises approximately 125,000 chickens per year at her farm located about 100 miles west of Washington, D.C.   Her farm is defined under EPA regulations as a CAFO.   Alt filed suit during June 2012, after EPA issued her an Administrative Compliance Order (ACO) which determined that her farm was in violation of the Clean Water Act (CWA) for discharging pollutants without a federal permit.

In the ACO, EPA accuses Alt of releasing dust consisting of feathers, dander and manure into the air from ventilation fans in her chicken barns.  EPA has no authority to regulate the emissions of dust and other particles onto land under the CWA; instead, the EPA claims that an unpermitted discharge occurs after the dust from the barns settles on the ground, mixes with stormwater and eventually reaches jurisdictional waters of the United States through man-made ditches.  EPA’s Order requires Alt to apply for a National Pollutant Discharge Elimination System (NPDES) permit and threatens her with a civil enforcement action if she fails to apply.  Statutory civil penalties under the CWA can reach $37,500 per day.

By way of background, the CWA requires point sources, including CAFOs, to obtain NPDES permits if the point source “discharges” into waters of the United States.  CAFOs historically have not been required to obtain NPDES permits because Congress exempted agricultural stormwater discharges from permit requirements.  CAFOs are frequently designed to prevent the discharge of pollutants and are described as “zero discharge facilities.”  Alt’s farm is a dry litter facility and wastewater is not discharged from the inside of the broiler houses; the only water that runs off the farm is rainwater.

The emission of particles containing dust, dander and manure from large farms is nearly unavoidable.  As a result, EPA’s order against Alt has substantial implications for farmers across the country.  If EPA prevails in this suit, thousands of large animal farms across the country may be subject to NPDES permitting requirements.  NPDES permits often include onerous provisions that require farmers to expend considerable sums of money and devote substantial managerial resources in order to comply with these requirements.

Until recently, recipients of ACOs could not challenge the EPA in federal court and were left with the unreasonable option of either complying with the order and applying for a permit or doing nothing and running the risk of substantial fines.  In March 2012, the U.S. Supreme Court, in Sackett v. EPA, unanimously held that recipients of ACOs could bring suit under the Administrative Procedure Act without awaiting an EPA enforcement action.   The Alt case is one of the first post-Sackett challenges to an ACO.  At a minimum, the right to bring suit against EPA gives farmers and others who receive ACOs a new ability to challenge excessive governmental authority.

The Alt case also represents the next chapter in EPA’s continuing efforts to require CAFOs to obtain NPDES permits.  During the past ten years, EPA has promulgated several rules which require CAFOs to obtain NPDES permits.  In 2003, EPA began requiring CAFOs to obtain NPDES permits if the CAFO discharged or had the “potential to discharge.”  In 2005, the Second Circuit, in Waterkeeper Alliance v. EPA, held that CAFOs could not be required to obtain NPDES permits on the basis of the “potential to discharge,” noting that the CWA only provided EPA with NPDES permitting authority over “actual discharges.”  In response to the Waterkeeper decision, EPA released a new CAFO Rule in 2008 which required CAFOs to obtain an NPDES permit if the facility discharged or “proposed to discharge.”  Not surprisingly, the Fifth Circuit struck the “propose to discharge” language in a 2011 case, National Pork Producers Council v. EPA.

It is now clear that EPA does not have authority under the CWA to require CAFOs to obtain NPDES permits unless those facilities “actually discharge.”  In response, EPA has turned its attention to air emissions from CAFOs in an attempt to establish “actual discharges” through the release of particles from ventilation fans.  If it succeeds in the Alt case, EPA will be one step closer to requiring CAFOs to obtain NPDES permits regardless of the lack of any impact the facility has on federal waters.  The Order granting the Farm Bureaus permission to intervene will begin to level the playing field as those associations have resources that Alt may not be able to provide on her own.

The Ag/FDABlog will be monitoring Alt v. EPA and providing readers with updates as they occur.

George S. McGovern

By Marshall L. Matz

There has been an outpouring of emotion and praise mourning the loss of  Senator George S. McGovern.  While he was a liberal Democrat, he is being recognized as a great humanitarian by both Republicans and Democrats.  From President Obama and Vice President Biden, to the Secretary General of the United Nations and Senator Bob Dole, all are mourning the loss of a politician who, in the end, rose above politics.

Senator McGovern was also a much beloved member of our law firm serving in the capacity of a Senior Policy Advisor, working with us on behalf of food, agriculture and nutrition clients.  Our conference room is, and will remain, the McGovern Conference Room.  When the law firm moved to the Watergate last year, McGovern said: “I sure hope no one breaks into my office this time.”

I was the Senator’s senior counsel on nutrition policy, his  friend and advisor for 40 years.  My statement on the passing of George McGovern follows:

“George McGovern had an extraordinary, full life, and his impact will be felt for years to come. He was a decorated WWII bomber pilot, Member of Congress, the first Director of Food for Peace (under President Kennedy), South Dakota’s Senator for eighteen years, the Democratic Nominee for President in 1972, U.N. Ambassador and so much more.

“His most enduring legacy, however, will be in the fight against hunger here at home and around the world. As was noted by President Bill Clinton when he awarded him the Presidential Medal of Freedom, George McGovern was one of the great humanitarians of our time. McGovern made a commitment to the issue of fighting hunger in the 1960s and inspired many others into action. Together with Bob Dole, his friend and colleague, they expanded the food stamp program, the school lunch and breakfast programs, and created the Women, Infants and Children (WIC) program.

“After the Senate, McGovern’s leadership continued through his work at the United Nations and his own personal standing. When President Clinton launched the McGovern-Dole International School Nutrition Program in 2000 with a $300 million commitment, he said “George, it’s good to see that you are still at it.”  In many ways, McGovern was the grandfather of President Obama’s Feed the Future effort and the G8’s emphasis on food and agriculture.

“Today, 31 million children will participate in the school lunch program, 10 million will have a school breakfast, 9 million mothers and children will participate in the WIC program and 46 million people will participate in the food stamp program.   Internationally, millions of the poorest children will have one meal at school and will attend school in order to receive that meal. For the girls, it will change their lives. George McGovern is responsible for all of this, along with the nutrition labels on our foods.

“George McGovern’s legacy on food and nutrition is without equal and will be felt all over the world for many years to come. He was the man who fed the world.”

Here’s Your Chance to Fix the Budget

By Gary Zizka

With three weeks to go in the election season, federal budget and tax policy has taken center stage. Candidates on both sides of the political divide have had to reduce complex policy issues to sound bite-sized propositions.  What’s lost in the debates is an understanding of the full, interconnected complexity and clash of values that these decisions represent.

Fortunately, there are several great online, federal budget simulators or games available for you to use to get an excellent appreciation of just what is involved.  Regardless of your perspective and political interest, you can use these simulators to see how difficult are the choices which face Congress and the next Administration under either a President Obama or President Romney.  And, they’re fun, too!  So, have at it—be a Budget Hero:

  • Budget Hero, created by American Public Media, lets you select from a collection of “values badges” as you proceed to learn about and make choices between spending priorities and taxation options. It’s graphically well-designed and features a satisfying cash register sound when you save us money. The object of the game is to push off fiscal disaster as far into the future as possible.
  • The Concord Coalition’s “Federal Budget Challenge” offers more detail and more options to address the deficit, and you can print out a nice summary when you’re done. The Coalition is a nonpartisan nonprofit founded in 1992 by the late Sen. Paul Tsongas, former Sen. Warren Rudman and former Commerce Secretary Peter Peterson to advocate fiscal responsibility.
  • The New York Times’ November 2010 Deficit Project simulator, while somewhat out of date fiscally speaking, allows for the more politically-feasible  compromise measures to reduce the deficit, such as reducing, rather than eliminating, tax expenditures and spending programs. The Times also features a more recent (Jan. 2012) simulator dealing only with the defense budget. It’s worth a try, too.
  • Finally, if you really want to get down into the weeds and shoot for a target of stabilizing total U.S. debt at 60 percent of Gross Domestic Product by 2021, try the Committee for a Responsible Federal Budget’s Simulator.

Good luck!

Safety v. Innovation – How the European Commission’s Proposed Regulation Hopes to Strike the Right Balance

By Kathryn E. Balmford

Back in January, Jeff Shuren, M.D., the Director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration (FDA), made headlines when comparing the European Union’s (EU) regulation of medical devices to FDA’s.  When asked by a reporter whether proposed changes to FDA’s 510(k) premarket clearance system were aimed at lessening industry’s premarket burden (more consistent with the European approach), Dr. Shuren quoted a plastic surgeon as saying, “Under the EU system, the public are being used as guinea pigs.”  He then added, “we don’t use our people as guinea pigs in the U.S.”  While his remarks sparked outrage on the part of his European counterparts, Dr. Shuren’s point has not fallen on completely deaf ears across the pond.

On September 26th, the European Commission released its long-anticipated proposed regulation aimed at overcoming the flaws and gaps in the EU existing regulatory framework, the Medical Device Directive (MDD).  One of the system’s flaws stems from the lack of a centralized government approval process.  In the United States, if a company wants to bring a medical device to market, it must meet FDA’s requirements – including, in the case of most Class II and Class III devices, obtaining premarket clearance or approval from FDA that its device is safe and effective for its intended use.  Conversely, in the EU, if a company wants to bring a medical device to market, it pays a notified body (i.e., a private company certified by a European Member State) to conduct a conformity assessment and review documentation demonstrating the device’s safety and quality.

It is not so much that the company pays for the notified body’s services – as even in the US, companies have been paying user fees for FDA to review their applications for years – it is that notified bodies do not consistently interpret and apply the standards set forth in the MDD.  In addition, the competent authorities in each Member State are not necessarily aware that a device has received a CE-mark from a notified body before the product reaches their market.  If a safety concern arises once the device is on the market, a coordinated response across Member States is not easy to organize.

One of the benefits of the European regulatory framework is that notified bodies are numerous and, therefore, generally able to perform their premarket duties faster than FDA.  This fact, coupled with a lower approval standard for high risk devices, has led some to characterize the European system as more supportive of innovation and patient access to novel products.  However, according to FDA, there is a price to pay for faster approvals supported by less clinical data, and that price is paid by European patients.  See Unsafe and Ineffective Devices Approved in the EU that were Not Approved in the US, FDA (May 2012).

The European Commission’s proposed Regulation includes several features intended to further strengthen patient safety and respond to criticism of the current regulatory framework.  With respect to premarket requirements, several reforms have been proposed, including:

  • Stronger supervision of notified bodies by competent authorities;
  • Additional authority for notified bodies (e.g., unannounced facility inspections, sample testing);
  • Manufacturer submission of a safety and effectiveness summary to a public EU-wide database; and
  • Creation of a Medical Device Coordination Group (MDCG) authorized to review notified body preliminary conformity assessments for high-risk devices before such products receive a CE-mark and enter the market.

It is this last “scrutiny mechanism” that has the best chances of catching unsafe, high-risk devices before they harm patients.  While the proposal steers clear of creating a centralized government approval process, by establishing the MDCG, the European Commission has attempted to address potential safety concerns and increase collaboration among Member States.

Of course, that is only one side of the story.  According to industry, the scrutiny mechanism will only deter innovation and slow patient access to novel technologies.  As the proposed Regulation is just now entering the legislative phase with the European Parliament and Council, it remains to be seen how the EU will ultimately balance the safety of its patients with the concerns of its manufacturers.

Scaling Up African Agriculture

By Marshall L. Matz, as published in the October 3, 2012, issue of Agri-Pulse.

Last week in Arusha, Tanzania, former United Nations Secretary General Kofi Annan told 1,200 delegates attending the African Green Revolution Forum (AGRF) that “African agriculture is now accelerating beyond the tipping point” and is the long term solution to global food and nutrition security.  Mr. Annan is correct on both points. The African Green Revolution is now under way and it is the key to both African and global food security.

Agriculture development has long been viewed as the economic key to Africa, but it is not always recognized as the solution to global food security and our ability to feed nine billion people by 2050.  Africa has 60 percent of the underutilized agricultural land in the world and is, therefore, the key to global food security.

To read the article in its entirety, click here.

POM Wonderful vs. FTC: The Epic War Continues

By Tish Eggleston Pahl

There are some spectacles we geeks in the food and drug bar follow as avidly as any mini-series. The epic, two-year battle between POM Wonderful (producer of pomegranate products) and the Federal Trade Commission (FTC) is almost as addictive as HBO’s “Game of Thrones” – only without all the beheadings.

Though POM Wonderful extols the health benefits of pomegranates and their juice, the FTC insists that the company’s product claims are not substantiated by competent and reliable scientific evidence, in violation of the FTC Act.  Last week, the FTC won a round when U.S. District Court Judge Richard Roberts dismissed POM Wonderful’s complaint against the FTC.  POM Wonderful LLC v. The Federal Trade Commission, Civil Action No. 10-1539 (RWR) (Sept. 30, 2012).

Battle lines were drawn in 2010 when the FTC entered into orders with Iovate Health Sciences and Nestle HealthCare Nutrition.  The FTC required both of those companies to possess two adequate and well-controlled human clinical studies to support their product health claims; FDA also had to pre-approve any disease claims for Nestle products.

In September 2010, POM Wonderful launched the first salvo when it sued the FTC, alleging that the agency imposed these new substantiation requirements unlawfully.  POM Wonderful was prescient, because two weeks later the FTC counter-attacked.  It filed an administrative complaint, challenging the company’s health claims for its pomegranate products.  This administrative complaint was eventually followed by a 345-page decision by the FTC’s Administrative Law Judge (ALJ).

The ALJ decision was a draw for Pom Wonderful and FTC staff.  The ALJ found some of POM Wonderful’s claims to be false and misleading, but also rejected the FTC’s demands that POM Wonderful obtain FDA pre-approval and conduct two clinical studies.  Appeals followed, with oral argument before the FTC Commissioners in August.  A decision is expected by December 2012.

With the Commission decision pending, the combatants turned to the federal district and, this time, POM Wonderful lost.  Judge Roberts found that POM Wonderful’s preemptive filing two weeks before the FTC’s administrative suit left “the disfavored appearance that POM hastily filed the instant case, in part, to secure tactical leverage from proceedings in this forum.”  In light of the advanced administrative proceeding, allowing the case to proceed in federal court would not help resolve the matter and so Judge Roberts dismissed Pom Wonderful’s complaint.

The adversaries withdraw for now and await the full Commission’s ruling. However, POM Wonderful can return to federal court by appealing any final FTC judgment against it. The battle may be over, but the war promises to continue.

OFW Law’s John Block Participates in Panel of Former USDA Secretaries

By John R. Block, Secretary of the U.S. Department of Agriculture from 1981-1985

Recently, I had the pleasure of joining three other former Secretaries of Agriculture at the University of Nebraska for a lively and informational discussion to celebrate the 150th anniversary of the Morrill Act, which created the land grant college system back in 1862. When I get the opportunity to spend time with Dan [Glickman], Clayton [Yeutter] and Mike [Johanns], it’s always a great evening. We discussed the challenges and opportunities for the American agriculture industry and took questions from students.  Ronnie Green, one of the moderators of the event and Vice President of the University, shared his hope that, in the audience of 1500, there might be one or two future Secretaries of Agriculture.   I hope so, too.

You can read more about the event in the Lincoln Journal Star by clicking here.

Deadly Meningitis Outbreak Linked To Compounded Steroid— The Tipping Point For Compounders?

By Tish Eggleston Pahl

CDC (as of Oct. 4, 2012)

Five people are dead and another 35 are very ill due to a fungal meningitis outbreak in six states.  The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) have traced the outbreak to the New England Compounding Center Inc.  Media sources report that over 17,000 vials of the epidural steroid in three lots were distributed to 75 healthcare facilities in 23 statesThe CDC and FDA warn that this outbreak will likely spread before being contained.

This follows on the heels of other serious outbreaks also linked to pharmacies that compounded contaminated drugs:

  • 33 people in 7 states suffered vision loss and blindness due to a fungal endophthalmitis outbreak linked to an injectable dye produced by Florida compounder Franck’s Lab.

Franck’s Lab has been embroiled in litigation with FDA since compounding a product that killed 21 polo horses in April 2009.  The scope of FDA’s authority over compounding of drugs for non-food animals has been fully briefed and will be argued before the 11th Circuit Court of Appeals on November 1, 2012 in US. v. Franck’s Lab, Inc., et al. (11th Cir. No.11-15350).  In May 2012, Franck’s ceased compounding and distributing its sterile preparations because they might not have actually been sterile.

I discussed this unfolding tragedy with my colleagues Arthur Tsien and Steve Terman and we wonder if, in a few years, we’ll look back on this as a turning point in the regulation of compounding pharmacies.  On the one hand, FDA defers to State Boards of Pharmacy to regulate traditional compounding practice where a pharmacist mixes-to-order drugs (like the enrofloxacin I must administer to my disapproving rabbit via a syringe).  On the other hand, FDA’s Compliance Policy Guide describes what activities could turn a compounding pharmacy into a commercial-scale drug manufacturer.  FDA has long pursued pharmacies it believes are unlawful drug manufacturers.

Patient deaths have historically spurred Congressional action.  After over 100 deaths due to Elixir of Sulfanilamide, Congress passed the 1938 Food, Drug, and Cosmetic Act, requiring manufacturers to show a drug’s safety prior to marketing. Next week marks the 50th anniversary of the Kefauver-Harris Amendment, enacted in response to the thalidomide tragedy in Europe, in which Congress required FDA to approve drugs before marketing and demand greater proof of safety and efficacy.

Maybe 2012 and compounded steroids will be the tipping point in stricter oversight of compounders.

FDA has now updated its webpage with information on the outbreak here.

California’s Prop 37 — A Prop Too Far?

By Robert A. Hahn

On election day, California voters will decide on another food labeling ballot initiative, one that is being watched intently by the food industry.  If it passes, the California Right to Know Genetically Engineered Food Act, popularly known as “Prop 37” (short for Proposition 37), would require genetically engineered foods to be labeled as such.

Specifically, Prop 37 would:

  • Require genetically engineered raw agricultural commodities to be labeled “genetically engineered” on the front label;
  • Require processed foods with genetically engineered ingredients to be labeled “[May be] partially produced with genetic engineering” on the front label;
  • Prohibit any processed food from being labeled “natural,” even if the food is not genetically engineered;
  • Exempt several categories of foods, including restaurants foods, alcoholic beverages, and meat and poultry, from the labeling requirement; and
  • Authorize private plaintiffs to sue to enforce the law.

Putting aside the question of whether Prop 37 is sound public policy, there is a good chance it will be struck down as unconstitutional if it passes, and the entire exercise will have been a waste of time and money.

While other constitutional challenges to Prop 37 (e.g., dormant Commerce Clause) are possible, a lawsuit alleging that Prop 37 violates the First Amendment appears all but certain.  Generally, a law that seeks to regulate (i.e., restrict or compel) commercial speech must pass the test enunciated by the U.S. Supreme Court in Central Hudson Gas & Elec. Corp. v. Public Service Commission, 447 U.S. 557 (1980).  Under the Central Hudson test, a law compelling commercial speech must involve a substantial government interest, must directly advance that government interest, and must be no more extensive than is necessary.  If the Central Hudson test is applied to Prop 37, it’s difficult to see how a court could find it constitutional.

(1)  Is there a substantial government interest in mandatory labeling of genetically engineered foods?

The proponents of Prop 37 say that there is a consumer “right to know” which foods are genetically engineered.  The Statement of Purpose in section 2 of Prop 37 states that its purpose is “to create and enforce the fundamental right of the people of California to be fully informed about whether the food they purchase and eat is genetically engineered.”  Is satisfying that consumer right to know a substantial government interest?

In the closest precedent available, the consumer’s right to know was held not to be a substantial government interest.  In 1994, the State of Vermont enacted a law mandating labeling of milk produced from cows treated with recombinant bovine growth hormone (rbGH), also knows as recombinant bovine somatotropin (rbST).  In International Dairy Foods Association v. Amestoy, a case brought by a dairy industry trade association, the Second Circuit Court of Appeals held that the Vermont labeling requirement violated the First Amendment.  The court acknowledged a strong interest in this information among Vermont consumers, but held that “consumer concern is not, in itself, a substantial interest.”  According to the Second Circuit, “were consumer interest alone sufficient, there is no end to the information that states could require manufacturers to disclose about their production methods.”

The U.S. Food and Drug Administration’s (FDA) position also undercuts any argument that there is a substantial government interest in labeling genetically engineered foods.  FDA considered requiring special labeling of all bioengineered foods, but decided against it.  The agency concluded that the fact that a food has been genetically engineered is not a material fact.  If the genetically engineered food is significantly different from its traditional counterpart (e.g., in terms of nutritional value, safety, or functionality), then it must be labeled to indicate the difference, but the fact that a food was produced using bioengineering, by itself, is not a material fact.  The American Medical Association has similarly stated that there is no scientific justification for special labeling of biotech foods.

(2)  Does mandatory labeling of genetically engineered foods directly advance that government interest?

Even if there is a substantial government interest in labeling all foods produced using genetic engineering, Prop 37 arguably fails to directly advance that government interest, because it exempts so many categories of food from its labeling requirement.  Exempt categories include all foods served in restaurants and other food facilities primarily engaged in sale of food for immediate consumption; food derived entirely from animals such as meat, poultry, and milk (unless the animal itself has been genetically engineered); and alcoholic beverages.  Prop 37 also contains a large loophole: a food is exempt if there is a sworn statement from the food’s supplier that it has not been knowingly or intentionally genetically engineered or commingled with genetically engineered foods.  Even if there is a substantial government interest in satisfying the consumer right to know which foods are produced using biotechnology, with so much of the food supply exempt from its labeling requirement, it is not clear that Prop 37 would directly advance that government interest.

(3)  Is a law mandating labeling of genetically engineered foods more extensive than is necessary to advance the government interest?

Stated otherwise, is there a way to advance the consumers’ right to know which foods are genetically engineered without mandating a new labeling requirement?  A reasonable case could be made that there is, and it is already in place.  It’s called the National Organic Program, administered by the U.S. Department of Agriculture.  The right to know which foods have been genetically engineered is clearly motivated by a desire to avoid those foods.  Consumers who want to avoid genetically engineered foods can already do so by purchasing certified “organic” foods, which are prohibited from using genetic engineering.  If a food is not labeled “organic” and it contains ingredients derived from corn, soybeans, or other crops commonly known to be genetically engineered, an educated consumer can assume it has genetically engineered ingredients.

If the ballot initiative passes, the battleground will shift to the courts.  It will no doubt be intensely fought.

Mirror, Mirror on the Wall: Nothing Magical about FDA Warning Letters for Cosmetics with Age-Related Claims

By Tish Eggleston Pahl

The evil queen sucks the life out of young maidens to sustain her flawless complexion in the movie Snow White and the Huntsman.  If you are wondering how the U.S. Food and Drug Administration (FDA) might regulate the claims for a product with such regenerative properties (minus the grisly maiden death), look no further.

Source: Snow White and the Huntsman Official Site

In early September 2012, FDA posted a warning letter to Lancôme USA and yesterday posted warning letters to Andes Natural and Janson Beckett Inc.   In all three letters, FDA objected to anti-aging claims that (magically) turned these cosmetic products into unapproved new drugs in violation of the Federal Food, Drug and Cosmetic Act (FDC Act).

Objectionable claims on the companies’ respective websites included:

  • “[B]oosts the activity of genes and stimulates the production of youth proteins” (Lancôme USA);
  • “[U]nique R.A.R.E. oligopeptide helps to re-bundle collagen”  (Lancôme USA);
  • “Alpha Lipoic Acid, the most potent antioxidant on the market today, helps repair aged skin while preventing future damage” (Janson Beckett);
  • “[H]elps to protect against and repair environmental skin damage and signs of aging while stimulating collagen synthesis” (Janson Beckett);
  • “[S]timulate collagen growth and cellular regeneration thereby improving … sagging, reduction of imperfections and blemishes … ” (Andes Natural); and
  • “Stimulates the formation of glycosaminoglycans … helps to thicken the dermis resulting in a lessening of sagging and less fine lines and wrinkles”  (Andes Natural).

The FDA also took Andes Natural to task for products bearing acne claims which either must be subject to New Drug Applications under section 505 of the FDC Act, or must be labeled and formulated consistent with the final monograph for over-the-counter acne drugs.

It is sometimes a murky line between drugs that affect the structure or function of the body and cosmetics that alter appearance.  Cosmetics cannot make structure/function claims under the FDC Act.   Longstanding FDA policy classifies moisturizers as cosmetics, even though they arguably achieve their purpose by affecting the structure or function of the body.  As any woman of a certain age knows (of whom I am one) anti-aging claims are very common in the cosmetics aisle.  FDA issued an import alert for cosmetics making anti-aging claims in 1988.  Signaling that it was becoming impatient with the continued aggressive marketing, FDA began steadily adding companies to its watch list in 2009 and 2010, and finally re-issued the import alert in March 2012.  The warning letters seem to be another step in the agency’s efforts to make the claims on cosmetic moisturizers a little less magical.