Did You Know That Sunglasses Are Regulated by The FDA As Medical Devices?

Whether you import sunglasses into the United States or sell sunglasses in the U.S. commerce, you are required to comply with the laws and regulations of the U.S. Food & Drug Administration (FDA). The FDA regulates sunglasses products to ensure their safety and impact resistance. These products are regulated as medical devices as they are intended to mitigate or prevent the effect of the sun's ultraviolet (UV) rays on the eyes of a person. The term “Medical Device” is defined in 21 CFR 201(h).

The following are FDA regulations that apply sunglasses. Failure to comply with them may result in CBP and FDA detaining your sunglasses at the U.S. port of entry.

Dietary Supplement Labeling Do’s and Don’ts

You don’t want to miss this one! The U.S. Food and Drug Administration (FDA)’s top rationales for detention of dietary supplements include non-compliant labeling, products subject to an Import Alert, unauthorized claims, and more. Consistently, we encounter dietary supplements with outrageous claims turning the intended use of the products into “drugs” instead of Supplements. In this webinar we will explore the confusion surrounding suitable structure/function claims versus disease claims made on Dietary Supplements and the nuances involved behind the FDA’s approach of deciding what constitutes a valid claim. Participants will also what’s required on a dietary supplement label, best practices and how to handle FDA enforcement actions, and much more! Don’t delay, RSVP Today!

UPDATE: FDA Delays Compliance Dates for the New Nutrition Facts Label Rule

In an earlier article, we detailed some of the new changes that would be implemented with the new Nutrition Facts Label rule. That article also provided the compliance dates for the rule. On September 29,2017, however, the FDA proposed yet another deadline extension for

FDA Targets Vending Machine Operators

Co-Authored by Jennifer Diaz and Kristina Hernandez-Tilson, an attorney in Miami, Florida, practices in state and federal court, litigating matters of civil and administrative law. 

Since April 2008, pursuant to New York City Health Code Section 81.50, all Starbucks (and many other restaurants) in New York City have been required to display the calories of each of the menu items. A subsequent study found that this mandatory calorie posting influenced consumers in NYC, causing average calories per transaction to drop by 6%. The study also found that calorie posting did not cause any significant change in Starbucks’ overall revenue.

Now, owners and operators of vending machines across the U.S. are next. Back in December of 2014, the Food and Drug Administration (FDA) issued a final rule entitled “Food Labeling: Calorie Labeling of Articles of Food in Vending Machines”. This rule is codified at 21 CFR 101.8, and requires vending machine operators who own or operate twenty (20) or more vending machines, or who voluntarily register with FDA to be covered, to declare calories for those vending machine foods for which the Nutrition Facts label cannot be examined before purchase or for which visible nutrition information is not otherwise provided at the point of purchase. According to the December 2014 final rule, covered vending machine operators must comply by December 1, 2016.

FDA’s Declared War on Sugar

Take a look at any food label. Check out the back panel entitled Nutrition Facts”. It should look similar to the image on the left. Take a look at the total carbohydrate. In this sample, the total carbs is 37g, with 4g of dietary fiber, and 1g of sugar. That leaves 32g of carbohydrates unaccounted for! What are those carbs you might wonder? Well, a majority of them are added sugars. 

FDA Finally Issues Definition of "GLUTEN FREE"!

FDA issued the update below DEFINING the term "Gluten Free".   As a Celiac, this is extremely exciting news! The reason this is a HUGE deal?  Us Celiac's need to know we can trust food products that are labeled "gluten free".  If they are not, the repercussions are severe, ranging from serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers...

My sincere hope is FDA will now test imported products that make "GLUTEN FREE" claims, and assure these companies are legitimately using the gluten free claim.  Meaning, I hope FDA will enforce and penalize those that are importing misbranded product and not correctly utilizing the gluten free claim!  The enforcement tools I will look for include FDA detaining imported product making gluten free claims, and sending them to FDA's own laboratories to check the parts per million of gluten in the product.  If the product contains more than 20 parts per million of gluten, FDA should refuse admission of the product - meaning it would need to be exported or destroyed within 90 days of the refusal, otherwise, companies would face a liquidated damages claim. I also hope FDA will take the added step of adding non-compliant companies to the FDA's Import Alert (black list) so that the products are AUTOMATICALLY stopped before entering the U.S. and the importer is forced to prove compliance prior to getting FDA to release the goods.

The "Compliance Date" for this final rule is August 5, 2014. If consumers see products labeled "gluten free" we should be able to TRUST that those products legitimately do not contain gluten. Now, we have a standard. Products labeled gluten free must contain LESS than 20 parts per million of gluten to be legitimately labeled so.

This is a fantastic start!!! Here's what the FDA had to say, and the actual FINAL RULE is included as a hyperlink at the end.

FDA defines “gluten-free” for food labeling
New rule provides standard definition to protect the health of Americans with celiac disease
The U.S. Food and Drug Administration today published a new regulation defining the term "gluten-free" for voluntary food labeling. This will provide a uniform standard definition to help the up to 3 million Americans who have celiac disease, an autoimmune digestive condition that can be effectively managed only by eating a gluten free diet.

“Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s new ‘gluten-free’ definition will help people with this condition make food choices with confidence and allow them to better manage their health.”

This new federal definition standardizes the meaning of “gluten-free” claims across the food industry. It requires that, in order to use the term "gluten-free" on its label, a food must meet all of the requirements of the definition, including that the food must contain less than 20 parts per million of gluten. The rule also requires foods with the claims “no gluten,” “free of gluten,” and “without gluten” to meet the definition for “gluten-free.”

The FDA recognizes that many foods currently labeled as “gluten-free” may be able to meet the new federal definition already. Food manufacturers will have a year after the rule is published to bring their labels into compliance with the new requirements.

“We encourage the food industry to come into compliance with the new definition as soon as possible and help us make it as easy as possible for people with celiac disease to identify foods that meet the federal definition of ‘gluten-free’” said Michael R. Taylor, the FDA’s deputy commissioner for foods and veterinary medicine.

The term "gluten" refers to proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains. In people with celiac disease, foods that contain gluten trigger production of antibodies that attack and damage the lining of the small intestine. Such damage limits the ability of celiac disease patients to absorb nutrients and puts them at risk of other very serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers.

The FDA was directed to issue the new regulation by the Food Allergen Labeling and Consumer Protection Act (FALCPA), which directed FDA to set guidelines for the use of the term “gluten-free” to help people with celiac disease maintain a gluten-free diet.

The regulation was published in the Federal Register.

Gluten Free Labeling is Coming - But, First, FDA Wants to Hear From YOU!!!!

Imagine a world where a manufacturer’s claims that their products are “gluten free” could be trusted by U.S. consumers.  Imagine a world where U.S. consumers were promised a definition of “gluten free” by the U.S. Food and Drug Administration (FDA), and the FDA held all manufacturers and importers to the same stringent standard….

Good news, we’re getting close!!

As of August 2, 2011, FDA has re-opened the comment period so that they can hear from YOU.  Yes, YOU!  FDA wants to hear from Celiacs, gluten sensitive consumers, et al. in the U.S.  Why, you ask?  Well, the FDA is firming up their definition of “gluten free”; and wants to know that the gluten free community is satisfied with the FDA’s finalized definition.  So, let’s make sure we tell the FDA what's important to us.  FDA has proposed a definition of "gluten free" in order for the term to be used on labeling of food products.

FDA’s proposed rule defines “gluten free” as products that do not contain:

1. an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains
2. an ingredient derived from these grains and that has not been processed to remove gluten
3. an ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten
4. 20 ppm (parts per million) or more gluten

FDA wants to hear from the public and industry. The public comment period on the proposed rule will officially open after noon on Aug. 3, 2011, and will remain open for 60 days (until October 3, 2011). FDA prefers electronic comments, go to http://www.regulations.gov/ and

1. choose “Submit a Comment” from the top task bar
2. enter the docket number FDA-2005-N-0404 in the “Keyword” space
3. select “Search”

FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is tasked with making this happen, check out FDA's webpage which shows the safety assessment done to confirm 20 ppm is the correct standard to use.   

FDA held a conference call with industry, where the FDA allowed questions on opening up the comment period, and hopefully bringing truthful gluten free labeling to U.S. consumers soon.  Some questions asked where the methods in which FDA would test manufacturer’s products (answers were the Elisa R5 Mendez method, and Morinaga Method (currently used by the Japanese government for allergen labeling).  Presently, the Food Service and Products industry doesn't have to use these methods, but these are the methods FDA will use for enforcement.  

FDA is well aware that 20 ppm may not protect everyone, FDA wants your comments on this issue, what would truthful gluten free labeling be to you??  I was thinking about a range, 0-5 ppm, 5-10 ppm, 10-15 ppm, etc. to be included with “gluten free.”  FDA was also thinking about low/very low gluten labeling – but, what would be considered low?  What would be low or very low to you?  Tell the FDA!!

As far as timing goes, FDA will review the comments received, and is targeting the 3rd quarter of 2012 to publish a final rule.   

Yours truly asked the FDA about enforcement because I want to know how FDA will check on these products once these standards are implemented.  FDA advised there will be a compliance program set with the new rule, which will likely entail inspections, label review, (although I was hoping to hear about more lab testing of products).  Further, I asked about the size of FDA’s budget to assist in enforcement (once we all agree on definitions and a final rule comes to be…) but, there was no comment from the FDA on the budget to enforce (only a chuckle...).

We all think of the monsters out there who have preyed on Celiac’s/gluten free consumers, and did not in fact sell a gluten free product.  FDA will issue warning letters, seize products, issue injunctions, issue mandatory recalls, etc., when faced with manufacturers who are selling gluten free product that is NOT truly gluten free.

Let’s get to it, let’s tell the FDA you agree with 20 ppm, don’t agree, want low/very low standards (explaining what your tolerances are), or whatever your prospective may be.  FDA is listening, they want to hear from you, speak now!  You have until October 3 to have your voice heard before the final rule, and then, the hope is you will trust the products on your shelves that state, “gluten free”.