The Food Law Firm was recently interviewed by The Local Food Association (LFA), a national trade association for those engaged in the business of local food. LFA works to increase market access and market share for both sellers and buyers of local food across the United States. We are honored to have been included and look forward to working together.
-by Jason Foscolo
The haphazard legalization of hemp and particularly cannabis is creating an unpredictable legal environment for entrepreneurs. By “haphazard,” I mean that legitimizing marijuana as an industry does not simply stop at decriminalization. There are other aspects of law having nothing to do with criminal justice that can thwart the progress of the marijuana entrepreneur. Here are a few issues we’ve seen in the news and in our legal practice lately:
1. In the rush to create hemp industries, legislatures make sloppy mistakes. South Carolina recently made it legal to grow industrial hemp if the grower was “licensed,” but neglected to create a licensing scheme for interested growers. The statute thus creates an economically tantalizing but unobtainable opportunity for the state’s farmers.
2. Branding for marijuana and marijuana-based products, like soft drinks and gummy bears containing THC extracts, is very difficult to trademark. To qualify for federal trademark registration, the use of a mark in commerce must be “lawful.” Thus, any goods or services to which the mark is applied must comply with all applicable federal laws. So long as marijuana or its derivatives remain controlled substances at the federal level, producers of marijuana-based products will not be able to avail themselves of federal trademark protection. Trademark protection is absolutely fundamental to a successful brand, and the powerful range of anti-infringement benefits that come with it are denied to marijuana-based businesses.
3. While we are on the subject of edibles, food safety is a new area of regulation for marijuana entrepreneurs. Even after they become legit, some marijuana manufacturers seem to have trouble dropping some of their old habits, like processing bubble hash in old washing machines. This may be an example of a few bad apples, but it doesn’t help foster a positive image of an industry that is trying to legitimize itself. When the trade was illicit, inspectors didn’t scrutinize manufacturing processes because they never had the chance to do so. Now that they are starting to poke around with their swabs and thermometers, they are not thrilled about the safety of the food products being offered to the public.
4. The biggest potential obstacle by far for medical marijuana is drug labeling. Too many drug references on a food or beverage product label can earn a Warning Letter from the FDA stating that it is a “street drug alternative” and therefore, a drug as defined by the Food Drug & Cosmetic Act. The stakes are raised when particular health claims are associated with medical marijuana consumption. Marketing a link between marijuana and a given ailment is central to the idea of medicinal marijuana, but marketing anything as a drug is tightly controlled by the FDA. Though marijuana entrepreneurs may be very tempted to make the claim that, say, THC may alleviate some of the symptoms of conditions like Alzheimer’s Disease, they are in no position to assert the same kinds of claims that prescription drug manufacturers make on drugs that have been through the approval process. The FDA does not seem to be going after marijuana entrepreneurs for the claims that they are currently making, but that can change at any time. In the interim, the safest course of action would be to not make any medicinal claims.
The most important thing to remember is that just because the Department of Justice has de-emphasized prosecution of certain marijuana crimes does not mean that other agencies necessarily will grant a “pass” on the regulations within their domain to marijuana entrepreneurs. Growers and processors in this burgeoning industry need to assess regulatory risk from every angle.
Today, we are proud to announce that attorney and public health advocate Michele Simon is joining the firm in an of counsel capacity. Michele’s practice will focus on food and alcoholic beverage labeling and marketing compliance. Michele brings more to the firm than just her comprehensive knowledge of marketing regulations. As someone with great experience identifying the problems in food industry marketing tactics, she brings integrity and a unique perspective to help clients who want to do better.
by Michele Simon
Over the past 18 years as a lawyer and public health advocate, I have scrutinized the ways that food companies use misleading or illegal marketing to unfairly influence consumers. I will continue to call out these deceptive practices as long as the industry continues to use them.
Fortunately, the food industry is changing. More companies are entering the marketplace with healthier options that are less processed and contain higher quality ingredients. These companies lead with their values and seek more meaningful connections with their customers. This new breed of food producer, which places integrity over profit, is vital to help shift the marketplace.
One obstacle to success is regulation. Any new company has to abide by the rules to succeed. Marketing is the most important tool these companies have because it enables them to distinguish their products from those of Big Food. Most of the marketing terms that such companies want to use, such as organic, gluten-free, or high fiber, are strictly regulated. Others, such as non-GMO, may soon be regulated, and require a keen eye to avoid greenwashing or other deceptions.
Making sure a food or beverage meets with federal and state legal requirements is just the first step. These days, it’s entirely possible to meet the letter of the law but still get into other trouble. Food companies need to consider the potential risk of being targeted by advocacy organizations, class action attorneys, the competition, the media, and bloggers, all getting amplified by social media. Based on my years of advocacy experience, I can help companies avoid such scrutiny. My ongoing role as an advocate ensures that I will keep my finger on the pulse of new policies at the federal and state levels, as well as demands from advocacy groups and other key developments.
There is a compelling and urgent need for legal services for good food. After being immersed in marketing strategies and policy for almost two decades, the time is right for me to direct the benefit of my experience towards companies who want to do the right thing. In addition to my continuing work as a public health advocate, I am now offering legal guidance on food and beverage marketing. As a licensed attorney in California, I will begin taking and advising clients on:
- Comprehensive label review for FDA, USDA, and TTB (alcohol) compliance
- Compliance with the FTC Act and California consumer protection laws
- Marketing claims review for legal compliance and beyond
- Recommendations for reliable certifications such as organic and gluten free
- Becoming eligible under USDA guidelines for federal programs such as school food
- Compliance with emerging regulations such as menu labeling and revised Nutrition Facts
- Compliance with industry self-regulatory standards such as the National Advertising Division
- Rapid responses to competitor complaints to self-regulatory bodies
- Rapid responses to attacks by advocacy groups, food bloggers, or media
- Rapid responses to adverse legal action, such as FDA warning letters for marketing claims
I am excited to be collaborating with Foscolo & Handel PLLC on this important work. It’s an honor to work with Jason and Lauren, two talented lawyers who themselves have a tremendous amount of integrity, along with a healthy dose of passion and commitment to a better food system. I see this new direction as the private sector supplement to my public advocacy work and look forward to this new venture.
Please help me spread the word.
For legal services, reach me at: Michele@foodlawfirm.com / 510-465-0322
by Jack Hornickel
NPR recently highlighted a new tool for raw milk producers: third-party quality control standards and independent certification. The Raw Milk Institute (RAWMI), a non-profit that supports a strong and safe raw milk industry, has published safety criteria for raw milk producers. If farmers meet RAWMI’s Common Standards and draft an adequate Risk Analysis and Management Plan, they can be listed on the RAWMI website as exemplar producers of “reliable, clean raw milk.” Doctors, veterinarians, epidemiologists, farmers, and consumers all participated in developing the safety measures.
The Common Standards include water and milk testing that probes for the presence of coliforms, salmonella, listeria, and E. coli. They also require testing the dairy herd to ensure the animals are free of tuberculosis and brucellosis. The Risk Analysis and Management Plans are developed uniquely for each farm. Generally they must address contamination risks that occur during animal transportation, cleaning of milk containers, management of bedding and manure, feed storage, and contact with farm employees. The Plan mandates responsible reflection on the entire dairy process and seeks to identify all points where contamination can occur, thereby mitigating risk.
By mitigating the risk that a consumer may become ill, RAWMI’s standards should also minimize exposure to civil lawsuits. However, compliance with such voluntary standards will not immunize a raw milk producer from civil liability or from criminal liability where raw milk sales are illegal. Because raw milk laws are different in each state, the independent certification offered by RAWMI will have varying effects depending on the location of the farm.
In New York, for example, dairies can sell raw milk from the farm after receiving a license. The standards for obtaining a license are similar to the RAWMI Common Standards but require additional testing for staphylococcus and organisms that cause mastitis in dairy cows. New York also requires farmers to post a sign reading, “Raw milk does not provide the protection of pasteurization.” Thus, raw milk producers that are independently certified by RAWMI are well on their way to being licensed by the state. By taking a few extra steps, farmers would be shielded from criminal liability.
New Jersey is another story. In that state, all sale of raw milk for human consumption is illegal. The RAWMI certification will do nothing to protect a New Jersey producer from criminal prosecution. In fact, listing on the RAWMI website is likely to draw attention to the illegal enterprise, and the paper trail of bacterial testing and food safety plans is evidence that can be used in a prosecution. Here, independent certification would raise the chances of criminal liability, despite the farmer’s honest attempt to provide safer food.
Now for the final twist: RAWMI’s standards will have only a minimal effect on farmers’ civil liability. In every state, raw dairies face strict liability in civil lawsuits for harms caused by the food products they sell. If anybody becomes sick from consuming a raw milk product, the producer can be held liable for the consumer’s injuries, even if the producer followed the highest safety standards. Raw dairies, like all food producers, have an absolute duty to make a safe product. The only effects RAWMI’s certification could have in a civil lawsuit might be to insulate the farmer from a negligence claim, an alternate theory on which a consumer could sue, as well as punitive damages.
RAWMI’s certification is a practical step forward, falling short of a legal solution. The Common Standards and Risk Analysis and Management Plan are a laudable attempt to legitimize and create industry-wide standards for the raw milk industry. However, they will have varying effects on farm liabilities, and farmers still must continue to navigate the patchwork of state laws. For a comprehensive guide to state raw milk laws, visit the Farm-to-Consumer Legal Defense Fund website.
by Jack Hornickel
The saga of Sriracha, the addictive sauce that waters my eye just at hearing the name, came to a close earlier this summer. The manufacturer of liquid fire, Huy Fong Foods, Inc., had come under increasing legal pressure from its host city, Irwindale, California, to turn down the spice — not in the product itself, but in the surrounding airspace. The city had attempted enjoin Sriracha production as a public nuisance after receiving numerous complaints from the factory’s neighbors. In response, hot sauce junkies and restaurateurs were shocked and took to hoarding the familiar rooster-clad, green-capped bottles. Ultimately, after some legal and commercial posturing, the parties came to an undisclosed agreement to keep the Sriracha facility up and running, and the city dismissed its lawsuit.
Sriracha is truly an American success story. David Tran, a Vietnamese immigrant, launched Huy Fong in 1980. Named after the vessel that carried its founder to the United States, Huy Fong began production in Los Angeles and later moved to Rosemead, CA. In 2010, the company broke ground on a new $40 million, 650,000-square-foot factory in Irwindale, CA that would at least triple its production capacity.
It took less than two years for the complaints to start rolling in. Neighbors bemoaned of standard respiratory ailments − coughing, sneezing, burning throats − but also more alarming agitations – headaches, bloody noses, even swollen glands. According to Irwindale residents, the chili sauce production really disrupted daily life. One resident resorted to popping heartburn medication before her morning jog. Others reported a looming red cloud of terror, a la John Carpenter’s The Fog. Overall, at least 18 households filed formal complaints with the city.
The antagonizing odor was allegedly caused by the production of Huy Fong’s flagship Sriracha sauce. Moreover, the trouble was intensified by Huy Fong’s production methods. In order to preserve the fresh spiciness of its red jalapeno peppers, the saucier grinds an entire year’s worth of peppers in the three months of harvest season! At peak production, about 40 truckloads of California red jalapenos are delivered and processed each day. During these months, residents report that the offensive odor can be irritating half of a mile away.
On October 21, 2013, after the conclusion of that year’s harvest season, the City of Irwindale filed a complaint against Huy Fong. It alleged that the sauce manufacturer constituted a public nuisance by creating conditions that were injurious to public health, or were indecent and offensive to the senses, such that it interfered with the comfortable enjoyment of life and property. A judge then granted a preliminary injunction on November 26, halting any Sriracha operation that would cause emission of offensive odors. Despite recognizing the lack of credible evidence proving causation, the court reasonably inferred that the irritating odors were a result of Huy Fong’s hot sauce. (Ya think?) The court then determined that the city and its residents would be irreparably harmed if the plant continued to operate pending trial.
As this year’s pepper harvest season approached, on March 21, 2014, Irwindale turned up the heat and amended its complaint to include a breach of contract claim. The city alleged that Huy Fong violated its operating permit by emitting the offensive odors. City attorneys stressed that this was not a separate attack, but rather an additional legal theory by which the city could halt the extreme irritation of its residents. Yet, of the available remedies for a breach of contract, a court is least likely to order specific performance. Thus, Irwindale was most likely adding this theory to its case so that, even if it lost on the theory of public nuisance, it could hold the threat of monetary damages over the hot sauce producer.
During the court proceedings, Huy Fong did its fair share of posturing. Employing 60 full-time and 200 seasonal workers, the sauce manufacturer is an economic staple in the city populated by about 1,400. Leveraging its position as a coveted manufacturing-sector job-creator, Huy Fong hosted a group of Texan officials from the state’s agricultural, economic development, and tourism departments, a clear indication that it was considering a move. Sufficiently spooked, the City of Irwindale, with the assistance of the California Governor’s Office of Business and Economic Development, brokered a deal in a closed-door meeting. The details of the bargain are yet unknown, but Irwindale dismissed its lawsuit on June 4th, and Huy Fong has been engaged in another chili melee this summer.
The lesson: If your food production creates a public nuisance, you’d better be properly represented, employ a lot of people, and make a damned good product.
by Jack Hornickel
The USDA’s Risk Management Agency (RMA) is on its way to providing insurance coverage for all organic crops, but farmers may have to wait another growing season before their investment is accurately protected by federal insurance programs. The trouble is that certified organic crops fetch higher sales prices than conventionally-grown crops; yet most organic crops only can be insured at conventional rates because the data for organic pricing remains limited. Previously, only three organic crops were priced: corn, soy, and cotton. The 2014 Farm Bill instructed RMA to determine pricing for all organic crops “as soon as possible, but not later than the 2015 reinsurance year.” While the beginning of the insurance year varies per crop, the RMA is nowhere near establishing price rates for all organic crops.
A recent RMA update tracks its progress and strategic plan moving forward. In addition to corn, soy, and cotton, the RMA has now established price rates for organic:
- almonds (only in California),
- apples, fresh (Idaho, Oregon, and Washington),
- avocados (California),
- blueberries (all types in California; Early to Late Highbush type in Oregon and Washington),
- grapes, Concord (Oregon and Washington),
- pears (Oregon and Washington),
- peaches, nectarines, plums, and apricots (California),
- stonefruits, fresh (Idaho, Oregon, and Washington), and
- tomatoes, processing (California).
Clearly, the RMA has a long way to go before all organic farmers are fairly protected. Those on the eastern seaboard are particularly out of luck. Until the RMA is able to collect more robust and regional data that establishes the true value of organic production, federal insurance programs will continue to cut short on organic farmers.
In the meantime, the RMA recommends the following insurance programs that organic farmers can use to protect themselves at full organic value:
- Contract Price Addendum – If organic farmers are growing crops under contract, they can use the contracted sale price as a price rate for federal insurance programs. This method can even be used for organic crops that have established price rates, providing insurance that is more reflective of the actual crop value. Currently, this coverage is available for 62 organic crops.
- Actual Revenue History – This pilot program offers insurance based on the farmer’s actual documented revenue, protecting against losses based on yield, price, and/or quality. Unfortunately, the program is only available for cherries, navel oranges, and strawberries and limited to the states of California, Idaho, Oregon, and Washington.
- Adjusted Gross Revenue and AGR-Lite – Based on income reported on federal tax returns, organic farmers can insure any agricultural production. AGR is available selectively by state, and AGR-Lite is available almost everywhere.
- Whole Farm Revenue Protection – Designed for diversified farms, this new pilot program allows farmers to insure an entire farm rather than a specific commodity. Whole Farm Revenue Protection uses the same calculation as AGR and AGR-Lite but increases coverage. More information will be available later this summer.
by Jason Foscolo
Ariel Schwartz at fastcoexist.com postulates the fascinating idea that aerial drones can be used to circumvent so-called “ag gag” laws that restrict the use of photography and video to expose the abuse of livestock. The idea is so original it deserves detailed consideration. The article’s subtitle posits: “Some states have made it illegal for people to take photos or video of livestock operations. Drones to the rescue?”
Upon examining a few state ag gag laws, it appears that drones may be a viable way for activists to circumvent the laws, but not because the drones do not qualify as “people.” Drones instead make it possible to exploit ambiguities in trespass law.
Some states’ ag gag laws simply would not apply to the drone hypothetical. For example, Iowa’s law (Iowa Code § 717A.3A) states that “a person is guilty of agricultural production facility fraud” if the person obtains access to an agricultural operation by false pretenses, or makes a false statement on a job application in order to perform an act within the facility “not authorized by the owner.” Basically, this statute makes it illegal to lie on a resume in order to surreptitiously film inside of an ag business.
Similar to the Iowa law, Utah (Utah Code Annotated § 76-6-112) criminalizes entry by a person into an agricultural operation under false pretenses for the purpose of taking pictures as well. The Utah law, however, goes a bit further by also criminalizing the taking of pictures and video during a criminal trespass. Interestingly enough, “entry” is defined as “intrusion of the entire body” onto someone else’s land (Utah Code Annotated § 76-6-206). This “body” requirement makes this the one specific ag gag statute we found so far which could be circumvented by a flying Go Pro.
Kansas (K.S.A.§ 47 – 1827) prohibits a person from entering into an animal facility, not then open to the public, or remaining concealed after invitation, with intent to “take pictures by photograph, video camera or by any other means.” In essence, this is just a specialized form of trespass.
Idaho’s law (Section § 18-7042 of the Idaho Code) is both a beefed-up trespass statute and a “don’t lie on your resume” statute. It criminalizes a “person” who “is not employed by an agricultural production facility and enters an agricultural production facility by force, threat, misrepresentation or trespass,” obtains “employment with an agricultural production facility by force, threat, or misrepresentation with the intent to cause economic or other injury to the facility’s operations” or who enters “into an agricultural production facility that is not open to the public and, without the facility owner’s express consent or pursuant to judicial process or statutory authorization, makes audio or video recordings of the conduct of an agricultural production facility’s operations.”
Montana criminalizes the unauthorized acquisition or exercise of control over a production facility. The act also prohibits entry into an animal facility to take pictures by photograph, video camera, or other means with the intent to commit criminal defamation (Montana Code Annotated § 81-30-103). Montana makes the most deliberate effort to broaden the definition of “person” to include “a state agency, corporation, association, nonprofit corporation, joint-stock company, firm, trust, partnership; two or more persons having a joint or common interest; or some other legal entity” (Montana Code Annotated § 81-30-102).
For those ag gag laws predicated on entry into an agricultural facility, a hypothetical drone case is not likely to turn on the personhood of the drone. There may be some elasticity in the definition of personhood that is not contemplated by the statute but nevertheless would allow a criminal prosecution. Any ag gag prosecutor could argue that a person mediates their presence through the drone, which is under his or her control. The flying machine would be considered an extension of the operator for the purposes of establishing presence. Typically, a person can be liable for a trespass if he or she causes a thing to enter onto someone else’s property.
These cases are more likely to turn on the issue of whether a trespass or entry has occurred. A drone does not “enter” a facility in the way that all of these ag gag statutes contemplate, and whether or not a trespass can be committed by a remote controlled flying camera is ambiguous. The Volokh Conspiracy had a great post about drones and trespass from a few years back, which explains that land owners have the right to “exclusive control of the immediate reaches of the enveloping atmosphere,” which includes “at least as much of the space above the ground as he can occupy or use in connection with the land.” Given the novelty of drone technology, there is yet no clear indication of how low is too low for drone flight to be considered a trespass. An ambiguity this big, especially in the realm of criminal law, is ripe for exploit by animal welfare organizations.
The Supreme Court’s POM v. Coca-Cola Decision: Complying With FDA Labeling Rules Is No Longer Good Enough
by Laura Gaudreau
With a 8-0 decision on June 12, the Supreme Court welcomed another player to question the legality of food and beverage labels: competitors. In Pom Wonderful, LLC v. The Coca-Cola Company, the Court unanimously held that competitors may bring federal Lanham Act claims alleging unfair competition from false or misleading food product labels, even if those labels comply with FDA regulations.
POM Wonderful, a marketer of pomegranate juice products, sued a competitor, Coca-Cola, alleging that the labeling of Coke’s pomegranate blueberry flavored juice blend was deceptive and misleading under §43 of the Lanham Act and hurt POM’s sales. Coke’s product label prominently featured the words “Blueberry Pomegranate” even though the beverage consisted of 99% grape and apple juice, and was only about 0.2% blueberry juice and 0.3% pomegranate juice. Significantly, Coke’s labeling was permissible under the extensive FDA rules governing juice product names.
The issue before the Supreme Court was not the label itself, but the intersection between the Food, Drug, and Cosmetic Act (FDCA) and the Lanham Act. The FDCA prohibits the misbranding of food through false or misleading labels. Private parties may not bring enforcement suits under the FDCA, so the FDA has nearly exclusive enforcement authority. In contrast, the Lanham Act confers private rights of action, allowing business to sue competitors for unfair competition and false advertising. The Court evaluated whether FDA’s extensive regulation of food labeling under the FDCA precludes private claims challenging food labels under the Lanham Act.
The lower courts sided with Coca-Cola, which claimed the FDCA precludes a Lanham Act claim because the Lanham Act may not be used to preempt or undermine the FDA’s authority. Essentially, Coca-Cola claimed if the juice label satisfied the rules of the FDA, it had the stamp of approval for sale, and could not be challenged through private action via other statutes.
The Supreme Court disagreed with the lower courts, holding that competitors are allowed to bring Lanham Act claims alleging unfair competition from false or misleading food product labels. Justice Kennedy wrote the opinion, noting the two statutes are complementary. The FDCA is concerned primarily with public health and safety, while the Lanham Act protects commercial interests from unfair competition.
This decision potentially opens the door for a high volume of litigation over food labels, and puts substantial power in the hands of competitors. In his decision, Kennedy noted that competitors’ “awareness of unfair competition practices may be far more immediate and accurate than that of agency rule makers and regulators” due to their knowledge of how “consumers rely upon certain sales and marketing strategies.” Likewise, competitors have a financial incentive and possibly greater resources than FDA to challenge deceptive food labeling. Moving forward, food manufacturers must now be concerned not only with whether their labeling complies with FDA regulations, but also with whether it may invite lawsuits from competitors.
by Jack Hornickel
This post is not intended to poke fun at any faith particularly or religion generally. Rather, it is meant to examine the possible implications of the Supreme Court’s policy of corporate personhood for laws meant to protect and inform consumers.
On Monday, the Supreme Court handed down a ruling in Burwell v. Hobby Lobby Stores, Inc., one of its most controversial cases this term. In an ideological 5-4 split, the Court ruled that closely-held, for-profit corporations operating on sincere religious principles are protected by the Religious Freedom Restoration Act of 1993 (RFRA) from laws of general applicability that burden the exercise of religion. Hobby Lobby, an Oklahoma-based arts and crafts chain, objected primarily to the contraceptive mandate promulgated by the Department of Health and Human Services, pursuant to the Affordable Care Act.
The dissenting justices, however, argued that the Court’s decision would open the door for corporations to remove certain medical practices from their healthcare plans, such as vaccinations, blood transfusions, and antidepressants, on the grounds of corporate religious liberty. But what effect, if any, could the Hobby Lobby ruling have on the laws governing food producers?
During oral argument, Justice Alito posed an apt hypothetical: if Congress outlawed certain slaughtering techniques as inhumane, could kosher or halal butchers assert a religious exemption? (Nevermind momentarily that ritual slaughter is already explicitly exempt from the Humane Methods of Slaughter Act.) Answering his own question, Justice Alito’s opinion in Hobby Lobby would allow Jewish and Muslim butchers to opt out of such a law, so long as they were closely-held for-profit companies operating on sincere religious principles.
This leads me to wonder: could food purveyors bring challenges to other types of food laws based on the recent ruling? For example, the FDA protects consumers from misbranded foods by enforcing accurate labeling. Imagine now a company that produces wines and breads for Catholic communion (closely-held, for-profit, sincerely religious) that wishes to remind purchasers of the sacred mystery of transubstantiation by printing “Contains the Body and Blood of Christ” on its products. When the FDA takes enforcement action, could the corporation successfully sue under RFRA for burdening its exercise of religion? Likewise, the Church of Scientology utilizes a detoxification program that aims to promote spiritual wellness, relying on a routine of exercise, sweating, and vitamins. Could a company advertise the cocktail of vitamins as “Guaranteed to Heal Your Spirit” with impunity?
The possibilities are admittedly farfetched, but worth considering:
-Could a Muslim-owned business deny its employees their 60 minutes of mealtime during the month of Ramadan, contrary to state labor laws?
-Could producers of kosher beef, which must chew cud, challenge the Farm Bill provisions that favor corn-fed cattle?
-Could Rastafarians observing strict Ital challenge FDA regulations that do not require explicit labeling of hevery food additive?
In the wake of the Hobby Lobby decision, the conflict of food law and religion may one day reach the courts. Because RFRA covers “any exercise of religion, whether or not compelled by, or central to, a system of religious belief,” the cry of corporate religious freedom can be extended as far as any company wants to take it, so long as the belief is sincere. The Court assures in its opinion that federal courts are capable of “weed[ing] out” insincere religious beliefs. Only time will tell.
-by Jack Hornickel
Earlier this week, Food Safety News reported on a Los Angeles-based seafood distributor cited in an FDA Warning Letter for deficiencies in its seafood HACCP plan. This quote from the article caught our eye:
FDA’s district office used the warning letter to express its concerns about shortcomings the agency found in the company’s response to its earlier concerns.
Food Safety News drew this conclusion from the Warning Letter itself:
We acknowledge receipt of your written response dated October 18, 2013. We have reviewed your response, which included an updated HACCP plan, as well as corresponding records. However, based on your response and your HACCP plan that was provided, your canned raw scallops and canned pasteurized crab meat continue to be adulterated.
This is a perfect example of how the FDA will ratchet-up its enforcement authority if it receives an insufficient response from a food processor during an investigation. In this case, an inadequate response to a relatively discrete inspection precipitated a public flogging in the form of this Warning Letter. This exchange demonstrates why it is so utterly important to respond accurately and comprehensively to any issues raised by regulators during an FDA inspection.
Immediately after a facility inspection, FDA must meet with the company’s manager and discuss the findings. The FDA’s Investigations Operations Manual coaches FDA inspectors to advise the company that its response to the observed violations “may impact FDA’s determination of the need for follow-up action, if FDA receives an adequate response to the [results of inspection] within 15 business days.” While nothing in the law requires an inspected company to reply, a well-crafted response is a company’s best chance of avoiding a public warning and further enforcement.
The key takeaway from all this is to have an attorney review all communication with the FDA to ensure that no statement is made during an investigation that can expose the business to additional liability. FDA has a continuum of powers it can use against food businesses. The strongest administrative actions available are mandatory recall of adulterated food, suspension of food production, and temporary seizure of food products. Communication errors at any step during an investigation could provoke the FDA to use these powers, so food businesses have plenty of reason to tread very carefully throughout an inspection.