Oct 19

FDA Consultant Food Services

Our FDA Consultant Food and Beverage Services are comprehensive, to help our clients develop products that are compliant with federal laws and regulations. From ingredient reviews to label reviews, FDA registration and marketing reviews, we have FDA Consultant – Food Services to meet the needs of clients at every level and stage in the manufacturing and marketing process.

Ingredient reviews are used to determine whether particular products, as currently formulated, may be legally marketed in the United States without further regulatory approval. Because some ingredients may only be used in products that are classified as drugs, it is important to know whether your formulation would cause your product to be regulated more stringently and require pre-approval.

fda consultant food

FDA Consultant Food – Ingredient Reviews

Because products are regulated based on both their ingredients and intended use, ingredient reviews are often the first stage in determining how products are regulated. In addition, under FDA regulations ingredients generally must be declared according to their common or usual name. These regulatory requirements are applicable to foods, dietary supplements and other FDA-regulated products. More information about FDA regulations pertaining to ingredient declarations may be accessed here.

FDA Consultant Food – Label Reviews

The FDA has very specific requirements for the labels of the products it regulates. From the placement of information, to the formatting of the Nutrition Facts Panels and required statements, such as the Net Quantity of Contents, Statement of Identity, etc., compliance with FDA regulations can be a daunting process, but it doesn’t have to be this way. With our FDA Consultant – Food Label reviews are a key way of how we help our clients ensure that their product labels are fully compliant with FDA regulations.

If you would like to know more about FDA Consultant for food services or how hiring a FDA regulatory attorney can help you ensure that your labels are in compliance with FDA regulations, please feel free to contact us by phone at (786) 780-1544 or by email at contact@giannamore-law.com.

Dec 06

FDA Untitled Letters: FDA Warnings with a Twist

The U.S. Food and Drug Administration (“FDA”) has recently been issuing letters to companies that are distinct from traditional FDA Warning Letters. Referred to as FDA Untitled Letters, these letters must be taken seriously, as the terms of FDA Untitled Letters require the recipients to take immediate action once a letter has been issued.

FDA Untitled Letters: Why It Matters?

Many businesses may be well versed when it comes to handling FDA Warning Letters, but when it comes to FDA Untitled Letters recipients of Untitled Letters may not fully understand how to respond. Accordingly, there are a few things to keep in mind once a FDA Untitled Letter is received. First, an Untitled Letter should not go unanswered, as the terms of the Letter require response, and a comprehensive response thereto could potentially save a business from being issued a Warning Letter or other enforcement action.

Differences between FDA Warning Letters and FDA Untitled Letters

  1. Warning Letters describe alleged violations with both online marketing materials and print marketing materials, as well as product labels. Conversely, Untitled Letters appear to be focused solely on online marketing materials.
  1. Untitled Letters are typically not published on the FDA’s website, unlike FDA Warning Letters, which are routinely published on the FDA website. However, it is important to note that although the Agency does not automatically post FDA Untitled Letters, non-response may trigger publication, reinforcing the importance of a response to FDA Untitled Letters adequately and promptly.

Assistance with FDA Untitled Letters

If you have received an Untitled Letter from the FDA it is vital that you do not disregard the letter. In particular, the receipt of a FDA Untitled Letter may signal an additional chance to resolve the issues cited by the FDA before risking receipt and publication of a FDA Warning Letter. If you are unsure what a FDA Untitled Letter means and what action must be taken, our Firm is available to help you with this process. Whether it be FDA Warning Letters or FDA Untitled Letter we can help you develop and implement necessary, corrective measures before your products or business face consequences. If you are in need of assistance please contact us at contact@sglawfl.com.

Nov 03

FDA Regulation of Aromatherapy and Essential Oil Products

Aromatherapy and essential oil products are becoming more popular by the day, and marketing these products in compliance with federal regulations must be a key consideration for marketers and distributors of these products. On September 22, 2014 the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Young Living for alleged violations of the Federal Food, Drug & Cosmetic Act (FDCA) in connection with the marketing of their aromatherapy essential oils. According to the FDA, these violations stemmed from the Company’s claims of curing and treating diseases with the usage of Young Living Essential Oil aromatherapy products, causing the products to be deemed unapproved drugs by the FDA. The Warning Letter may be found here.

The FDA issued this warning to Young Living and its distributors for claiming numerous benefits on the labels of aromatherapy essential oil products with ingredients such as cinnamon, eucalyptus blue, ylang ylang and other essential oils. In addition to their labels, Young Living promoted these essential oils online, including the Company’s websites and social media platforms – with claims that the essential oils treat various conditions.

Here, Young Living was targeted by FDA because its aromatherapy and essential oils were incorrectly labeled and marketed. In particular, the Company failed to follow FDA guidance and regulations applicable to cosmetic products, and instead labeled their products for conditions that caused the products to be deemed drugs by the Agency. Thus, it is important for marketers and sellers of aromatherapy and essential oil products to understand and comply with FDA regulations.

As the aromatherapy and essential oil industry has recently seen a rapid increase in popularity, we expect to see more attention to and FDA enforcement in this area. Compliant labeling of products will help to ensure the successful marketing and sale of the aromatherapy and essential oil products. Our Firm offers the comprehensive label and marketing reviews to help our clients ensure that their products are fully compliant with all applicable FDA regulations. If you would like assistance with your products, please contact us at contact@sglawfl.com or (305) 507-9843.

Jun 07

Cosmetic Products and the FDA

FDA Regulation of Cosmetics Products

Importers introducing cosmetic products into the United States must be mindful of FDA regulations, which can present a barrier to market entry if the appropriate steps are not taken to ensure compliance. The U.S. Food & Drug Administration (“FDA”) works in conjunction with the U.S. Customs and Border Protection (CBP) to monitor cosmetic products at the time of entry. Noncompliance with FDA regulations can result in a shipment being refused entry into the United States or a product being recalled from the market after entry.

However, one may mistakenly assume that cosmetic products are subjected to the same FDA scrutiny as foods or medical device products. In fact, this is not the case; instead, the FDA’s focus on the cosmetics industry differs from the regulation of other FDA-regulated products. Unlike the FDA’s regulation of many other FDA-regulated, cosmetic products and their ingredients (with the exception of color additives) do not require FDA premarket approval and registration or approval requirements are largely inapplicable.

Cosmetic Products and Import Alerts

Due to the high volume of cosmetics imported into the domestic market, as a practical matter, not all cosmetics are inspected or sampled upon entry into the country. Rather than implement blanket inspections, the FDA focuses its inspection efforts on potentially risk-laden products in addition to conducting inspections of randomly-sampled products. As part of these targeted efforts, the FDA issues Import Alerts, which provide a risk monitoring system for the FDA and a signal to importers on the agencies regulatory focus. According to the FDA, Import Alerts for cosmetic products focus on cosmetic products marketed with therapeutic claims, those that are adulterated with microbial contamination, and products which fail to meet FDA requirements for color additives. As explained below, issues surrounding color additives present one of the more complex and important regulatory issues in the cosmetics industry.

Cosmetic Products and Color Additives

Under the authority of the Federal Food, Drug and Cosmetic Act (“FFDCA”), cosmetic products containing color additives are subject to a strict system of approval prior to entering the market. Certain color additives must be batch certified by FDA if they are to be used in cosmetics. Although some colors are exempt from batch certification, these colors are considered artificial colors, and when used in cosmetics or other FDA-regulated products, they must comply with the identity, specifications, uses, restrictions, and labeling requirements stated in the regulations.

Further, all color additives must meet the requirements for identity and specifications. Color additives may be used only for the intended uses stated in the regulations that pertain to them. The regulations also specify other restrictions for certain colors, such as the maximum permissible concentration in the finished product. With the exception of coal-tar hair dyes, failure to meet U.S. color additive requirements causes a cosmetic to be adulterated which may subject the product to removal from the market or detention. Accordingly, even when marketing cosmetics, there are important considerations from a FDA regulatory perspective, and compliance with these regulations will ensure smooth importation and marketing of cosmetics.

Navigating the web of regulations governing cosmetic products can be a daunting task. If you have any questions about FDA regulations or how these regulations relate to the marketing of a cosmetics products, please contact us at contact@giannamore-law.com.


Apr 20

FDA Imports: Tradeoff — Less Vigilance for More Diligence

The U.S. Food and Drug Administration (FDA) has found its ability to inspect and re-inspect all of the entities involved in food importing in a slow decline, resulting in delays for those dealing in FDA imports.  Troubled by its inability to get Congressional funding to pay all of its bills, the FDA came up with an idea: have the importer and the food manufacturer pay for the inspections and re-inspections.  With congressional approval, the Food Safety Modernization Act (2011) provides the FDA with the authority to charge such fees based on past costs (currently 2013) of inspections and re-inspections, and leverage this authority to get improved behavior from the importers, and food manufacturers, and related supply chain vendors.  The FDA is also offering a program where it will relax its typical schedule of inspection and re-inspection for those companies that prove great diligence in complying with FDA requirements pertaining to FDA imports, and join the FDA’s “Voluntary Qualified Importer Program” (VQIP).

What FDA Offers for FDA Imports (documented in VQIP):

Some of the benefits that the FDA offers to those who join VQIP and have records of diligence and compliance:

  • Near immediate release of FDA imports that are named in an approved VQIP
  • Prioritized analysis of samples taken for cause or health alert
  • Allow the importer to choose to be listed as a member of VQIP that is in good standing
  • A VQIP in good standing will face review only after three years

These and other benefits make the importer’s efforts less encumbered.  FDA Imports can be held “for as long as necessary”, but are typically held three days to a week due to the amount of imports that come through a port.  This delay does not include the need to take sampling when a public health alert occurs.  Also, an importer’s reputation can be enhanced by being listed on the FDA’s VQIP “good standing” site.

FDA’s Requirements (documented in VQIP):

Some of the requirements the FDA has for applicants and holders of VQIP approved applications are:

  • Have a VQIP “Quality Assurance Program” (QAP) – as a part of VQIP application submission
  • Have every importer, manufacturing and supplier entity involved in the food or foods in the VQIP application be in good standing with the FDA.  Those having no standing as yet with the FDA require an inspection with the cost of the entity’s inspection paid for by the entity or those entities under the application
  • A Dun & Bradstreet issued number (DUNS#) for each entity involved with the foods under the VQIP application.
  • Provide a food label for each food to be covered by the VQIP application with the VQIP application

The first two requirements listed, the QAP and the importer’s entire supply chain (IESC) in good standing with the FDA, are the ones that will be costly for the IESC.  If any part of the IESC gets an inspection finding, the existing VIQP application could be in jeopardy, and require re-inspection at IESC expense.  It is not an easy decision to make.

FDA’s Gamble: Hold Pat; But Needs Players

The FDA may be well-intentioned with implementations of FSMA, but its gamble on VQIP only pays off if importers see long term value in joining and complying with FSMA and VQIP.  Otherwise, it is business as usual, seeking budget from Congress, and looking for ways to do its job in the face of increasing numbers of importers and a budget that holds the FDA back.  Importers and their supply chain will continue to face delays in release, sporadic re-inspections that delay clearance of findings, and delays in getting information and help getting through the import / broker process.

We can help you in assessing what FSMA and VQIP mean to you as an importer or member of a supply chain, as well as other FDA regulations.  Together we would review the legal and regulatory basis for your VQIP application submission, and determine the appropriate measures needed to establish compliance with federal laws and FDA regulations on your behalf. For more information about hiring a FDA regulatory lawyer to help you make a knowledgeable decision on this FDA innovation, FDA imports, and benefit from diligent FDA compliance, please contact us at contact@giannamore-law.com.


Jan 21

District Court sides with Industry on Dietary Supplement Substantiation

A U.S. District judge New Jersey has ruled in United States v. Bayer Corporation that Bayer will not be held in contempt for alleged violations of a 2007 consent decree regarding the marketing of its Phillip’s Colon Health (PCH) product. The 2007 Consent Decree prohibited Bayer from “making any claim about the performance or efficacy of any dietary supplement, multivitamin or weight-control product unless, at the time Bayer makes the claim, the company possesses competent and reliable scientific evidence to support the claim.”  The current decision originates from a motion for an order to show cause filed by the Department of Justice (DOJ) on behalf of the Federal Trade Commission (FTC) and further originates from a 2011 FTC investigation concerning whether Bayer possessed competent and reliable scientific substantiation for its claims regarding PCH’s effectiveness as a digestive health product.

Based on evidence collected from its investigation, the DOJ’s motion alleged Bayer should be held in civil contempt for violating the 2007 consent decree concerning the requirement that Bayer substantiates its dietary supplement claims with scientific evidence. Specifically, the motion alleged that Bayer wrongfully made claims that PCH supports digestive health, and the product would help alleviate constipation, diarrhea, and gas and bloating without specific randomized, double-blind, placebo-controlled trials to prove that PCH offers these health benefits. In short, the Government’s position, like we have seen time and time again from the FTC, is that the Company must have conducted human studies in order to make the arguably dietary supplement-type claims.

In defense of the motion, Bayer produced as evidence a substantial amount of public domain and proprietary scientific evidence in support of its claims regarding PCH’s effectiveness in fostering digestive health. Further, Bayer argued the DOJ’s reliance on Bayer’s lack of substantiation of its product claims exceeded legislative intent for how dietary supplements should be regulated under the Dietary Supplement Health and Education Act (DSHEA). Thus, Bayer countnered the type of evidence required to substantiate claims under the DSHEA was not Laine-Level randomized clinical trials. In other words, Bayer argued that dietary supplements do not need the requisite level of substantiation that would be necessary for the approval of a drug under federal law. Accordingly, Bayer argued it only needed to conduct a periodic review of the literature since Bayer’s structure function claims were not implied disease claims and that the appropriate scientific substantiation standard for structure-function claims does not require Laine-Level randomized clinical trials.

The main takeaway from this is that for dietary supplement manufacturers making structure/function claims, courts may be willing to interpret this a less rigorous evidentiary burden when it comes to claims substantiation, as opposed to more highly regulated products. Additionally, and somewhat more controversially, this decision has been interpreted by some to signal that digestive health structure/function claims are more expansive than originally thought, potentially including constipation, diarrhea, gas and bloating.

Navigating the web of regulations governing claims regarding dietary supplements can be a daunting task. If you have any questions about FDA regulations or how they relate to the marketing of dietary supplements, please contact us at contact@giannamore-law.com.

Jan 11

FDA Clears Device via De Novo Process

On December 8, 2015, the U.S. Food & Drug Administration (“FDA”) cleared for marketing in the United States a cooling cap to reduce hair loss in breast cancer patients undergoing chemotherapy.  Marketed under the name the DigniCap® Cooling System, the cooling cap is manufactured by Dignitana, a Swedish company making its first foray into the United States medical device market.

After multiple clinical studies and extensive use in overseas markets, the DigniCap® scalp cooling system is the only such device to have completed an FDA-cleared multi-center clinical trial and is cleared for use with treatment regimens associated with breast cancer. More information about the device may be found here.

The FDA cleared the DigniCap through the de novo process. The de novo process, a relatively new pathway, provides an alternate means of clearing novel devices of low to moderate risk. Initially, Dignitana submitted the device for Premarket Approval (“PMA”) to the FDA at the beginning of 2015. After a brief review, the FDA converted the PMA to the de novo regulatory pathway since the FDA did not consider the DigniCap System a high-risk device warranting a PMA.

Through the De Novo process, device sponsors are able to utilize a hybrid-type pathway for clearance by bringing low-risk devices to market in situations where they would not otherwise be able to utilize the more confined 510(k) pathway. In particular, where the 510(k) pathway is most-frequently used to clear new devices, it is only available to those new devices that have a clear predicate device or are substantially equivalent to another legally marketed device. Devices that do not otherwise have a predicate device available but are still lower-risk that would be appropriate to merit a PMA, now have a pathway via the de novo process. More information about the De Novo process can be found here and here.

Navigating the FDA’s web of regulations governing medical devices can be a daunting task. If you have any questions about FDA regulations or how they relate to the marketing of a medical device, please contact us at contact@giannamore-law.com.

Jan 11

FDA “Natural” Food Labeling

On November 12, the U.S. Food & Drug Administration (“FDA”) announced that it is soliciting public comments on how the Agency should define the term “natural” and regulate its use in food labeling. The FDA has engaged the public’s input after receiving two Citizen Petitions requesting the agency take action on establishing a formal definition of the term “natural” for use in food labeling and one requesting asking that the agency prohibits the use of the term “natural” on food labels.

The FDA also notes that this recent move is driven by recent private litigation surrounding the term “natural” in which some federal courts requested administrative determinations from the FDA as to the propriety of labeling of food products containing genetically engineered ingredients or high fructose corn syrup as “natural.”

While FDA regulations presently do not offer a formal definition of the term “natural,” the Agency has maintained a longstanding policy concerning the use of “natural” in human food labeling. FDA’s nonbinding guidance on this subject defines “natural” as “nothing artificial or synthetic (including all color additives regardless of source) has been included in or has been added to, food that would not normally be expected to be in the food.”  Although this policy touches on the qualitative aspects of food, this policy does not address production methods and food processing or manufacturing methods. Further, the FDA also does not presently consider in its non-binding guidance whether the term “natural” should describe any nutritional or another health benefit derived from such foods.

As part of the public comment process the FDA requests information on whether it is appropriate to define the term “natural;” suggestions as to how the agency should define “natural,” and the term’s appropriate use of the term on food labels. The FDA is accepting public comments through February 10, 2016.

For more information about hiring a FDA regulatory lawyer to help you develop FDA-compliant labeling or how you can achieve FDA compliance, please contact us at contact@giannamore-law.com.FDA Lawyer

Sep 10

What’s in a Name? Everything, for “Standard” FDA Food Labeling


Particular words mean everything to the U.S. Food and Drug Administration (FDA).  It takes great pains and uses specific words to proclaim its position, and clarify what it names something, especially when it comes to setting a standard.  Most of us who have dealt with or follow FDA activities are well aware of FDA rules, such as those set forth in 21 CFR. What many do not know or realize is that the FDA has set standards for what is in, and what is not in, a commonly named food, such as mayonnaise, or tomato paste. These standards are a part of 21 CFR regulations.  Each of these foods, as well as many others, are set forth in 21 CFR Chapter 1, Sub-Chapter B, “Food For Human Consumption”. In these various sections the FDA states unequivocally what is in the food called “mayo” or “tomato paste”, and, often by omission, what is not in these foods.

May-o?  No, You are Not, by FDA Standard

As stated above, precision is essential to provide makers and sellers of food items and flavoring with clarity as to what their products are.  When a store or website advertises a human consumable food using “common names” like “Mayo”, “Mayonnaise”, or “Tomato Paste”, but has left out specific ingredients, or has added in specific ingredients that are not included in the regulations, the food item may have gone beyond the FDA definition and become a different food that may not use these identifying names.

In a recent warning letter, the FDA takes an internet food seller to task for such a violation. Found here, the FDA specifically targeted the company for marketing a food item as “mayo”, despite the fact that the product does not contain eggs. Makes it healthier, right? In addition to removing the egg component, the seller also has added a specific starch product to help with consistency of the food item. But, this is a component that is not typically in mayo.  For these and other reasons, the FDA tells the seller that it is misleading the public in its advertising, finding its labeling to be non-compliant with FDA food labeling regulations – in short, saying that mayo has eggs, and this product does not.

Another Path down into FDA Enforcement

In a too-familiar occurrence, when a seller violates one aspect of FDA food labeling regulations, the added event of labeling violations follows close behind. The standard phrasing of such violations called out in the FDA letter states: “This letter is not an all-inclusive statement of violations associated with your products or their labeling ….  It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.  We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.”  Now the seller must update the site, within 15 days, removing all references to “mayonnaise”.

FDA Compliance – Seller Must Know, and Follow, the Rules

It is essential that a person selling food items understand and comply with FDA food labeling regulations. FDA food labeling regulations are non-negotiable marketing requirements a seller must meet to avoid FDA warnings.

For more information about hiring a FDA regulatory lawyer to help you make a knowledgeable decision on these and other applicable FDA regulations, please contact us at contact@giannamore-law.com.FDA Lawyer

Jun 30

FDA Bans Trans Fats

FDA Issues Final Determination Concerning Partially Hydrogenated Oils

The U.S. Food and Drug Administration (FDA) has long reacted to the public concern over trans fatty acids (also known as TFA or trans fats) found in foods as a part of Partially Hydrogenated Oils (PHOs).  FDA recently issued its final decision on how it would categorize PHOs.  Following through on an effort the FDA began in 2013, the categorization of PHOs officially changed to not generally recognized as safe (GRAS) for use in food, effectively banning trans fats.  This change in categorization now puts PHOs under the regulations that govern food additives.  Current registrations of foods containing PHOs and their labeling must eliminate PHOs by June 2018.  The FDA will allow registrants to obtain new registration of use of PHOs in foods under much stricter guidelines.

FDA’s Long Pursuit of Trans Fats – A Troubled Relationship

The FDA began its relationship with trans fats and PHOs in 2006 when the FDA required that the amount of trans fats in a food be put onto the ingredients listing of the FDA-required Nutrition Facts label.  Trans fat is listed as a part of the Saturated Fat listing.  Since trans fat is typically a percentage of Saturated Fat, trans fat could list at zero grams but still be present in the food, up to 0.5 grams of trans fat, and allow the continued use of PHOs.  This is no longer the case.

The reason PHOs became important in the food industry is that PHOs have a longer shelf life and are cheaper than other fats and oils to use in recipes.  Removal of PHOs from a food means potential changes to the Nutrition Facts label for that food.  Additionally, for an imported food currently containing PHOs, the importer will be responsible for getting its food source manufacturer to reformulate and eliminate the PHOs.

FDA’s Scope on PHOs and Trans Fat is Black and White

Using the Federal Register to issue a Declaratory Order, rather than proceeding through formal rulemaking (with the necessary notice and comment periods) the FDA has set its boundaries on what is non GRAS, on what must be eliminated, and what occurs outside these boundaries.  One boundary is that this order is for PHOs only and excludes FHOs, fully hydrogenated oils.  The Order also excludes naturally occurring trans fats, those that are not a part of PHO manufacture.  The Order clearly defines PHOs as “as those fats and oils that have been hydrogenated, but not to complete or near complete saturation, and with an iodine value (IV) greater than 4.”    The Order also provides that “Any interested party may seek food additive approval for one or more specific uses of PHOs with data demonstrating a reasonable certainty of no harm of the proposed use(s).

FDA’s follow-up … What’s Next?

The FDA will be busy from now through June 2018 with updates to a multitude of Nutrition Fact labels, as well as new and revised food additive submissions seeking FDA’s approval to use PHOs in some “safe” manner.  For food imports containing PHOs, this means an updated recipe with an updated Nutrition Fact label, otherwise the importer may lose the ability to import.  FDA will then be able to seize imported foods and additives containing unapproved PHOS, categorizing them as adulterated, illegal imports.  With three years available to make necessary changes, violators will get little sympathy from the FDA, and may be subject to warning letters and seizure for continued non-compliance.

We can help you comply this order and other FDA regulations by reviewing the legal and regulatory basis for your updated Nutrition Facts label and determine the appropriate measures that need to be taken in order to reestablish compliance with federal laws and FDA regulations, if necessary. For more information about hiring a FDA regulatory lawyer to help you respond to this FDA Declaratory Order or how you can achieve FDA compliance, please contact us at contact@giannamore-law.com.


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